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- OBE022 is ObsEva's potential first-in-class, oral and selective PGF2alpha receptor antagonist for the treatment of preterm labor - Geneva, Switzerland and Boston, MA - 18 May 2017 - ObsEva SA (Nasdaq: OBSV), a Swiss biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman's reproductive health and pregnancy, today announced the completion of a Phase 1 study which investigated the potential drug-drug interactions of OBE022 when given with magnesium sulfate (MgSO4), betamethasone, atosiban, or nifedipine, medications typically used in women with preterm labor. "We are very pleased with the results of this Phase 1 drug-drug interaction study which supports our initiation of a Phase 2a study commencing later this year for the treatment of preterm labor. These data support the co-administration of OBE022 with tocolytics to prevent pre-term birth, as well as standard of care to improve the neonatal outcome of the premature baby." said Jean-Pierre Gotteland, CSO of ObsEva. OBE022 is a first-in-class, once daily, oral and selective prostaglandin F (PGF2alpha) receptor antagonist, which is in development for the treatment of preterm labor in weeks 24 to 34 of pregnancy. Based on pre-clinical models, OBE022 may potentially match the known tocolytic efficacy of prostaglandin inhibitors without the serious safety concerns reported with non-specific compounds such as indomethacin or other NSAIDs. Patients with threatened preterm delivery are usually treated with MgSO4 for fetal neuroprotection, betamethasone for accelerating fetal lung maturation and a tocolytic to suppress uterine activity. More than one tocolytic may be used in combination or sequentially if the primary choice is not effective. The combination of tocolytic treatments could potentially lead to additive or synergistic effects on uterine contractions. As a result of the limited efficacy and unfavorable safety profile of many current tocolytics used off-label to treat preterm labor, we believe there remains a significant unmet need for a selective prostaglandin inhibitor. Focus on the inhibition of only PGF2alpha to delay preterm birth may provide a safe treatment option for both mother and child. The drug-drug interaction Phase 1 clinical study was a randomized, open-label, single-centre Phase 1 study designed to assess the safety, tolerability and pharmacokinetics of OBE022 when co-administered with MgSO4, betamethasone, atosiban, or nifedipine to pre-menopausal healthy women. The study was performed in two parts: (A) single dose of OBE022, 12 hours MgSO4 infusion and co-administration of both, each separated by 7 days; (B) single dose of each of atosiban, nifedipine and betamethasone followed by co-administration of each of these compounds with multiple doses of OBE022. All studied OBE022 combination treatments were safe and well-tolerated. All but one treatment emergent adverse events (TEAE) were mild, one was moderate; there were no serious adverse events and no clinically relevant changes in safety parameters. No clinically significant abnormalities were detected in clinical laboratory results and the ECG assessments including QTcF evaluation did not reveal any clinically significant abnormalities. Single and steady state pharmacokinetics of OBE022 and its readily formed active stable metabolite OBE002 in pre-menopausal women were comparable to those in the Phase 1 first-in-women study with post-menopausal women. There were no clinically relevant interactions between OBE022 and MgSO4, betamethasone or atosiban while nifedipine exposure was increased. Given the results announced today, ObsEva intends to advance OBE022 into a Phase 2a Proof-of-Concept clinical trial in the second half of 2017 to assess the safety and efficacy of OBE022 to delay birth in women 24 to 34 weeks pregnant who face preterm labor and potentially preterm delivery. Preterm labor, defined as the body commencing the birthing process prior to 37 weeks, is a serious women's pregnancy health condition characterized by uterine contractions, cervical dilation and rupture of the fetal membranes that surround and protect the fetus during pregnancy. According to a study published in the Lancet in 2012, approximately 15 million babies were born before 37 weeks of gestation in 2010, accounting for 11.1% of all live births worldwide. Over 1 million children under the age of five died in 2013 worldwide due to preterm birth complications, and many infants who survive preterm birth are at greater risk for cerebral palsy, delays in development, hearing and vision issues, and often face a lifetime of disability. The rates of preterm births are rising in almost all countries with reliable data for preterm birth, and are associated with an immense financial impact to the global healthcare system. To date, preterm labor is a condition for which only treatments with limited efficacy or restrictive safety issues are available. In the United States, the evidence supports the use of first-line tocolytic treatment with beta-adrenergic receptor agonists, calcium channel blockers, or NSAIDs for short-term prolongation of pregnancy (up to 48 hours) to allow for the administration of antenatal steroids (e.g. betamethasone). Magnesium sulfate, used for fetal neuroprotection after tocolysis could also be used (up to 48 hours) to inhibit acute preterm labor. Approved tocolytic treatments in Europe include beta-adrenergic agonists, which carry severe maternal cardiovascular risks and intravenous infusions of atosiban (an oxytocin receptor antagonist). While NSAIDs can also be effective for controlling preterm labor, use of such drugs is limited, due to the threat of serious and sometimes life-threatening side effects to the fetus. Such side effects may include kidney function impairment, premature constriction of the blood vessel connecting the pulmonary artery and the descending aorta in a developing fetus, and higher risk of thrombosis of the intestinal arteries (a condition called necrotizing enterocolitis). ObsEva is advancing OBE022, a potential first-in-class, once daily, oral and selective PGF2alpha receptor antagonist designed to control preterm labor by reducing inflammation, decreasing uterine contractions, and preventing cervical changes and fetal membrane ruptures. PGF2alpha induces contraction of the myometrium and also upregulates enzymes causing cervix dilation and membrane rupture. In nonclinical studies, ObsEva has observed that OBE022 markedly reduces spontaneous uterine contractions in pregnant rats without causing the adverse effects seen with NSAIDs. ObsEva is a clinical-stage biopharmaceutical company focused on the clinical development and commercialization of novel therapeutics for serious conditions that compromise a woman's reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor and improving ART outcomes. ObsEva is listed on The NASDAQ Global Select Market and is trading under the ticker symbol "OBSV". For more information, please visit www.ObsEva.com. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "intend", "expect", "may", "plan," "potential," "will," and similar expressions, and are based on ObsEva's current beliefs and expectations. These forward-looking statements include expectations regarding the pharmacology study of OBE022, the potential benefits of OBE022 and the potential clinical development plan for OBE022, including the timing and scope of future clinical trials as well as the timing and outcome of future interactions with the appropriate regulatory authorities. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, ObsEva's reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of ObsEva's Annual Report on Form 20-F for the year ended December 31, 2016, and other filings ObsEva makes with the SEC from time to time. These documents are available on the Investors page of ObsEva's website at http://www.obseva.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.


- OBE022 is ObsEva's potential first-in-class, oral and selective PGF2alpha receptor antagonist for the treatment of preterm labor - Geneva, Switzerland and Boston, MA - 18 May 2017 - ObsEva SA (Nasdaq: OBSV), a Swiss biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman's reproductive health and pregnancy, today announced the completion of a Phase 1 study which investigated the potential drug-drug interactions of OBE022 when given with magnesium sulfate (MgSO4), betamethasone, atosiban, or nifedipine, medications typically used in women with preterm labor. "We are very pleased with the results of this Phase 1 drug-drug interaction study which supports our initiation of a Phase 2a study commencing later this year for the treatment of preterm labor. These data support the co-administration of OBE022 with tocolytics to prevent pre-term birth, as well as standard of care to improve the neonatal outcome of the premature baby." said Jean-Pierre Gotteland, CSO of ObsEva. OBE022 is a first-in-class, once daily, oral and selective prostaglandin F (PGF2alpha) receptor antagonist, which is in development for the treatment of preterm labor in weeks 24 to 34 of pregnancy. Based on pre-clinical models, OBE022 may potentially match the known tocolytic efficacy of prostaglandin inhibitors without the serious safety concerns reported with non-specific compounds such as indomethacin or other NSAIDs. Patients with threatened preterm delivery are usually treated with MgSO4 for fetal neuroprotection, betamethasone for accelerating fetal lung maturation and a tocolytic to suppress uterine activity. More than one tocolytic may be used in combination or sequentially if the primary choice is not effective. The combination of tocolytic treatments could potentially lead to additive or synergistic effects on uterine contractions. As a result of the limited efficacy and unfavorable safety profile of many current tocolytics used off-label to treat preterm labor, we believe there remains a significant unmet need for a selective prostaglandin inhibitor. Focus on the inhibition of only PGF2alpha to delay preterm birth may provide a safe treatment option for both mother and child. The drug-drug interaction Phase 1 clinical study was a randomized, open-label, single-centre Phase 1 study designed to assess the safety, tolerability and pharmacokinetics of OBE022 when co-administered with MgSO4, betamethasone, atosiban, or nifedipine to pre-menopausal healthy women. The study was performed in two parts: (A) single dose of OBE022, 12 hours MgSO4 infusion and co-administration of both, each separated by 7 days; (B) single dose of each of atosiban, nifedipine and betamethasone followed by co-administration of each of these compounds with multiple doses of OBE022. All studied OBE022 combination treatments were safe and well-tolerated. All but one treatment emergent adverse events (TEAE) were mild, one was moderate; there were no serious adverse events and no clinically relevant changes in safety parameters. No clinically significant abnormalities were detected in clinical laboratory results and the ECG assessments including QTcF evaluation did not reveal any clinically significant abnormalities. Single and steady state pharmacokinetics of OBE022 and its readily formed active stable metabolite OBE002 in pre-menopausal women were comparable to those in the Phase 1 first-in-women study with post-menopausal women. There were no clinically relevant interactions between OBE022 and MgSO4, betamethasone or atosiban while nifedipine exposure was increased. Given the results announced today, ObsEva intends to advance OBE022 into a Phase 2a Proof-of-Concept clinical trial in the second half of 2017 to assess the safety and efficacy of OBE022 to delay birth in women 24 to 34 weeks pregnant who face preterm labor and potentially preterm delivery. Preterm labor, defined as the body commencing the birthing process prior to 37 weeks, is a serious women's pregnancy health condition characterized by uterine contractions, cervical dilation and rupture of the fetal membranes that surround and protect the fetus during pregnancy. According to a study published in the Lancet in 2012, approximately 15 million babies were born before 37 weeks of gestation in 2010, accounting for 11.1% of all live births worldwide. Over 1 million children under the age of five died in 2013 worldwide due to preterm birth complications, and many infants who survive preterm birth are at greater risk for cerebral palsy, delays in development, hearing and vision issues, and often face a lifetime of disability. The rates of preterm births are rising in almost all countries with reliable data for preterm birth, and are associated with an immense financial impact to the global healthcare system. To date, preterm labor is a condition for which only treatments with limited efficacy or restrictive safety issues are available. In the United States, the evidence supports the use of first-line tocolytic treatment with beta-adrenergic receptor agonists, calcium channel blockers, or NSAIDs for short-term prolongation of pregnancy (up to 48 hours) to allow for the administration of antenatal steroids (e.g. betamethasone). Magnesium sulfate, used for fetal neuroprotection after tocolysis could also be used (up to 48 hours) to inhibit acute preterm labor. Approved tocolytic treatments in Europe include beta-adrenergic agonists, which carry severe maternal cardiovascular risks and intravenous infusions of atosiban (an oxytocin receptor antagonist). While NSAIDs can also be effective for controlling preterm labor, use of such drugs is limited, due to the threat of serious and sometimes life-threatening side effects to the fetus. Such side effects may include kidney function impairment, premature constriction of the blood vessel connecting the pulmonary artery and the descending aorta in a developing fetus, and higher risk of thrombosis of the intestinal arteries (a condition called necrotizing enterocolitis). ObsEva is advancing OBE022, a potential first-in-class, once daily, oral and selective PGF2alpha receptor antagonist designed to control preterm labor by reducing inflammation, decreasing uterine contractions, and preventing cervical changes and fetal membrane ruptures. PGF2alpha induces contraction of the myometrium and also upregulates enzymes causing cervix dilation and membrane rupture. In nonclinical studies, ObsEva has observed that OBE022 markedly reduces spontaneous uterine contractions in pregnant rats without causing the adverse effects seen with NSAIDs. ObsEva is a clinical-stage biopharmaceutical company focused on the clinical development and commercialization of novel therapeutics for serious conditions that compromise a woman's reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor and improving ART outcomes. ObsEva is listed on The NASDAQ Global Select Market and is trading under the ticker symbol "OBSV". For more information, please visit www.ObsEva.com. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "intend", "expect", "may", "plan," "potential," "will," and similar expressions, and are based on ObsEva's current beliefs and expectations. These forward-looking statements include expectations regarding the pharmacology study of OBE022, the potential benefits of OBE022 and the potential clinical development plan for OBE022, including the timing and scope of future clinical trials as well as the timing and outcome of future interactions with the appropriate regulatory authorities. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, ObsEva's reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of ObsEva's Annual Report on Form 20-F for the year ended December 31, 2016, and other filings ObsEva makes with the SEC from time to time. These documents are available on the Investors page of ObsEva's website at http://www.obseva.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.


- OBE022 is ObsEva's potential first-in-class, oral and selective PGF2alpha receptor antagonist for the treatment of preterm labor - Geneva, Switzerland and Boston, MA - 18 May 2017 - ObsEva SA (Nasdaq: OBSV), a Swiss biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman's reproductive health and pregnancy, today announced the completion of a Phase 1 study which investigated the potential drug-drug interactions of OBE022 when given with magnesium sulfate (MgSO4), betamethasone, atosiban, or nifedipine, medications typically used in women with preterm labor. "We are very pleased with the results of this Phase 1 drug-drug interaction study which supports our initiation of a Phase 2a study commencing later this year for the treatment of preterm labor. These data support the co-administration of OBE022 with tocolytics to prevent pre-term birth, as well as standard of care to improve the neonatal outcome of the premature baby." said Jean-Pierre Gotteland, CSO of ObsEva. OBE022 is a first-in-class, once daily, oral and selective prostaglandin F (PGF2alpha) receptor antagonist, which is in development for the treatment of preterm labor in weeks 24 to 34 of pregnancy. Based on pre-clinical models, OBE022 may potentially match the known tocolytic efficacy of prostaglandin inhibitors without the serious safety concerns reported with non-specific compounds such as indomethacin or other NSAIDs. Patients with threatened preterm delivery are usually treated with MgSO4 for fetal neuroprotection, betamethasone for accelerating fetal lung maturation and a tocolytic to suppress uterine activity. More than one tocolytic may be used in combination or sequentially if the primary choice is not effective. The combination of tocolytic treatments could potentially lead to additive or synergistic effects on uterine contractions. As a result of the limited efficacy and unfavorable safety profile of many current tocolytics used off-label to treat preterm labor, we believe there remains a significant unmet need for a selective prostaglandin inhibitor. Focus on the inhibition of only PGF2alpha to delay preterm birth may provide a safe treatment option for both mother and child. The drug-drug interaction Phase 1 clinical study was a randomized, open-label, single-centre Phase 1 study designed to assess the safety, tolerability and pharmacokinetics of OBE022 when co-administered with MgSO4, betamethasone, atosiban, or nifedipine to pre-menopausal healthy women. The study was performed in two parts: (A) single dose of OBE022, 12 hours MgSO4 infusion and co-administration of both, each separated by 7 days; (B) single dose of each of atosiban, nifedipine and betamethasone followed by co-administration of each of these compounds with multiple doses of OBE022. All studied OBE022 combination treatments were safe and well-tolerated. All but one treatment emergent adverse events (TEAE) were mild, one was moderate; there were no serious adverse events and no clinically relevant changes in safety parameters. No clinically significant abnormalities were detected in clinical laboratory results and the ECG assessments including QTcF evaluation did not reveal any clinically significant abnormalities. Single and steady state pharmacokinetics of OBE022 and its readily formed active stable metabolite OBE002 in pre-menopausal women were comparable to those in the Phase 1 first-in-women study with post-menopausal women. There were no clinically relevant interactions between OBE022 and MgSO4, betamethasone or atosiban while nifedipine exposure was increased. Given the results announced today, ObsEva intends to advance OBE022 into a Phase 2a Proof-of-Concept clinical trial in the second half of 2017 to assess the safety and efficacy of OBE022 to delay birth in women 24 to 34 weeks pregnant who face preterm labor and potentially preterm delivery. Preterm labor, defined as the body commencing the birthing process prior to 37 weeks, is a serious women's pregnancy health condition characterized by uterine contractions, cervical dilation and rupture of the fetal membranes that surround and protect the fetus during pregnancy. According to a study published in the Lancet in 2012, approximately 15 million babies were born before 37 weeks of gestation in 2010, accounting for 11.1% of all live births worldwide. Over 1 million children under the age of five died in 2013 worldwide due to preterm birth complications, and many infants who survive preterm birth are at greater risk for cerebral palsy, delays in development, hearing and vision issues, and often face a lifetime of disability. The rates of preterm births are rising in almost all countries with reliable data for preterm birth, and are associated with an immense financial impact to the global healthcare system. To date, preterm labor is a condition for which only treatments with limited efficacy or restrictive safety issues are available. In the United States, the evidence supports the use of first-line tocolytic treatment with beta-adrenergic receptor agonists, calcium channel blockers, or NSAIDs for short-term prolongation of pregnancy (up to 48 hours) to allow for the administration of antenatal steroids (e.g. betamethasone). Magnesium sulfate, used for fetal neuroprotection after tocolysis could also be used (up to 48 hours) to inhibit acute preterm labor. Approved tocolytic treatments in Europe include beta-adrenergic agonists, which carry severe maternal cardiovascular risks and intravenous infusions of atosiban (an oxytocin receptor antagonist). While NSAIDs can also be effective for controlling preterm labor, use of such drugs is limited, due to the threat of serious and sometimes life-threatening side effects to the fetus. Such side effects may include kidney function impairment, premature constriction of the blood vessel connecting the pulmonary artery and the descending aorta in a developing fetus, and higher risk of thrombosis of the intestinal arteries (a condition called necrotizing enterocolitis). ObsEva is advancing OBE022, a potential first-in-class, once daily, oral and selective PGF2alpha receptor antagonist designed to control preterm labor by reducing inflammation, decreasing uterine contractions, and preventing cervical changes and fetal membrane ruptures. PGF2alpha induces contraction of the myometrium and also upregulates enzymes causing cervix dilation and membrane rupture. In nonclinical studies, ObsEva has observed that OBE022 markedly reduces spontaneous uterine contractions in pregnant rats without causing the adverse effects seen with NSAIDs. ObsEva is a clinical-stage biopharmaceutical company focused on the clinical development and commercialization of novel therapeutics for serious conditions that compromise a woman's reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor and improving ART outcomes. ObsEva is listed on The NASDAQ Global Select Market and is trading under the ticker symbol "OBSV". For more information, please visit www.ObsEva.com. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "intend", "expect", "may", "plan," "potential," "will," and similar expressions, and are based on ObsEva's current beliefs and expectations. These forward-looking statements include expectations regarding the pharmacology study of OBE022, the potential benefits of OBE022 and the potential clinical development plan for OBE022, including the timing and scope of future clinical trials as well as the timing and outcome of future interactions with the appropriate regulatory authorities. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials, ObsEva's reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of ObsEva's Annual Report on Form 20-F for the year ended December 31, 2016, and other filings ObsEva makes with the SEC from time to time. These documents are available on the Investors page of ObsEva's website at http://www.obseva.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.


Non-clinical results of OBE022 for PTL demonstrate both monotherapy/combination potential Geneva, Switzerland and Boston, MA - 29 June 2017 - ObsEva SA (Nasdaq: OBSV), a Swiss biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman's reproductive health and pregnancy, today announced it will make presentations at the European Society of Human Reproduction and Embryology (ESHRE) 2017 Annual Meeting, taking place July 2-5 in Geneva, Switzerland. These presentations will include the following: "We are pleased to have the opportunity to present to the medical community, these two sets of data from the development programs of two of our product candidates, nolasiban and OBE022." said Ernest Loumaye, MD, PhD, OBGYN, CEO and Co-Founder of ObsEva. "The results of the IMPLANT study with nolasiban, previously reported, show a potential absolute improvement of about 10 percent, or greater in live birth rate in women undergoing assisted reproduction for infertility. This magnitude of improvement, if replicated in our ongoing, 760 patients, Phase 3, IMPLANT-2 clinical trial that we began in March of 2017, could have a significant impact on patients undergoing IVF as currently only about one out of three patients will go home with a baby after an embryo transfer. The pharmacology data presented for OBE022 are also important as they not only indicate the potential of our compound to treat preterm labor as monotherapy but also displays additive effects with currently available treatments that have limited efficacy. We are utilizing these key data to design the Phase 2 program for OBE022 in pregnant women with preterm labor, which is scheduled to begin later this year." Infertility affects about 10 percent of reproductive-aged couples, with approximately 1.6 million ART treatments (including IVF and ICSI) performed worldwide each year. While the success of ART depends on multiple factors such as embryo quality and ET procedure, a successful pregnancy ultimately hinges on the receptivity of the uterus to accept embryo implantation. Uterine contractions at the time of ET, as well as suboptimal thickness of the uterine wall and blood flow to the uterus, may impair the implantation of the embryo. Nolasiban (previously known as OBE001), is an oral oxytocin receptor antagonist with the potential to decrease uterine contractions, improve uterine blood flow and enhance the receptivity of the endometrium to embryo implantation, all of which may increase the chance of successful pregnancy and live-birth among patients undergoing ART. ObsEva licensed nolasiban from Merck-Serono in 2013 and retains worldwide commercial rights. Preterm labor, defined as the birthing process starting prior to 37 weeks of gestation, is a serious condition characterized by uterine contractions, cervical dilation and rupture of the fetal membranes that can lead to preterm birth. According to a study published in the Lancet in 2012, approximately 15 million babies were born before 37 weeks of gestation in 2010, accounting for 11.1% of all live births worldwide. Over 1 million children under the age of five died in 2013 worldwide due to preterm birth complications, and many infants who survive preterm birth are at greater risk for cerebral palsy, delays in development, hearing and vision issues, and often face a lifetime of disability. The rates of preterm births are rising in almost all countries with reliable data for preterm birth, and are associated with an immense financial impact to the global healthcare system. To date, only treatments with limited efficacy or restrictive safety issues are available to treat preterm labor. In the United States, recommended first-line tocolytic treatments (medications that inhibit labor) include beta-adrenergic receptor agonists, calcium channel blockers, or NSAIDs, which are used for short-term prolongation of pregnancy (up to 48 hours) to allow for the administration of antenatal steroids (e.g. betamethasone). Magnesium sulfate, used for fetal neuroprotection can also be used (up to 48 hours) to inhibit acute preterm labor. Approved tocolytic treatments in Europe include beta-adrenergic agonists, which carry severe maternal cardiovascular risks, and intravenous infusions of atosiban (an oxytocin receptor antagonist). While prostaglandin inhibitors (NSAIDs) have been shown to be effective for inhibiting preterm labor, use of such drugs is limited, due to the threat of serious and sometimes life-threatening side effects in the fetus. Such side effects may include kidney function impairment, premature constriction of the blood vessel connecting the pulmonary artery and the descending aorta in a developing fetus, and higher risk of thrombosis of the intestinal arteries (a condition called necrotizing enterocolitis). ObsEva is developing OBE022, a potential first-in-class, once daily, oral and selective prostaglandin F2alpha receptor antagonist, which is designed to control preterm labor by reducing inflammation, decreasing uterine contractions, preventing cervical changes and fetal membrane rupture without causing the potentially serious side effects to the fetus seen with non-specific prostaglandin inhibitors (NSAIDs). PGF2alpha is believed to induce contractions of the myometrium and also upregulate enzymes causing cervix dilation and membrane rupture. In nonclinical studies, ObsEva has observed that OBE022 markedly reduces spontaneous and induced uterine contractions in pregnant rats without causing the fetal side effects seen with prostaglandin inhibitors such as indomethacin. ObsEva licensed OBE022 from Merck-Serono in 2015 and retains worldwide commercial rights. ObsEva is a clinical-stage biopharmaceutical company focused on the clinical development and commercialization of novel therapeutics for serious conditions that compromise a woman's reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor and improving ART outcomes. ObsEva is listed on The NASDAQ Global Select Market and is trading under the ticker symbol "OBSV". For more information, please visit www.ObsEva.com. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan," "potential," "will," and similar expressions, and are based on ObsEva's current beliefs and expectations. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials and related interactions with regulatory bodies, ObsEva's reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of ObsEva's Annual Report on Form 20-F for the year ended December 31, 2016, and other filings ObsEva makes with the SEC from time to time. These documents are available on the Investors page of ObsEva's website at http://www.obseva.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.


- OBE2109 is a GnRH receptor antagonist currently in development as both a stand-alone treatment and with add-back therapy designed to address the needs of endometriosis and uterine fibroid patients - Geneva, Switzerland and Boston, MA - 07 June 2017 - ObsEva SA (Nasdaq: OBSV), a Swiss biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman's reproductive health and pregnancy, today announced the completion of a Phase 1 clinical trial aimed at evaluating the PK/PD relationship of OBE2109 combined with different doses of add-back therapy. OBE2109 is a novel, oral GnRH receptor antagonist that is currently in a Phase 2b clinical trial for the treatment of pain associated with endometriosis (EM) and in Phase 3 clinical trials for the treatment of heavy menstrual bleeding (HMB) associated with uterine fibroids (UF) in pre-menopausal women. Although estrogen (E2) suppression is a well-validated strategy for alleviating symptoms of UF and EM, therapeutic benefit can be compromised by hypo-estrogenic effects, principally bone mineral density (BMD) loss.  This often necessitates administration of add-back therapy (ABT) to patients, which delivers estrogen/progestogens to counteract the deleterious effects of BMD. The ongoing OBE2109 development program is investigating two complementary approaches to achieving what ObsEva believes is the optimal estrogen level to find a balance between efficacy and side effects. The first approach is to use a "low" dose of OBE2109 that targets an E2 range of 20 to 60 pg/mL, without the addition of add-back therapy. The second approach targets maximal E2 suppression with a "high" dose of OBE2109, combined with add-back therapy to bring exogenous E2 back to the desired level that is intended to aid BMD safety. "We are very pleased by the results of this important PK/PD study in which we observed in Caucasian subjects the rapid onset and effectiveness of OBE2109 to reduce E2 levels that was previously reported in Japanese subjects," said Ernest Loumaye, MD, PhD, OB&GYN, CEO and Co-Founder of ObsEva. "We believe there are several important observations from this study that support our ongoing development strategy for OBE2109 as a treatment for EM and UF.  First, the OBE2109 dosages of 100 mg and 200 mg being tested in our ongoing PRIMROSE 1 and PRIMROSE 2 Phase 3 clinical trials, as well as add-back therapy of 1mg/0.5 E2/norethindrone acetate (NETA), appear to be doses that balance the intended therapeutic effect with deleterious side effects.  Second, as demonstrated by the median E2 level of 18 pg/mL following six weeks of dosing with 100 mg of OBE2109, upwards of 50% of patients may not require add-back therapy.  And third, the addition of add-back therapy intended to counteract BMD reduction appears to significantly moderate the potential benefit of GnRH antagonism, in terms of bleeding control as measured by rates of amenorrhea and spotting.  Therefore, we continue to believe that development of two regimens of administration for OBE2109 (with and without ABT) may best address the needs of the EM and UF populations." The present Phase 1 clinical trial reported herein aimed to evaluate the pharmacodynamics, safety, tolerability and pharmacokinetics of the oral GnRH receptor antagonist OBE2109 alone or co-administered with E2/NETA add-back therapy. This was a prospective, randomized, parallel group study involving 76 healthy, Caucasian women of child-bearing potential. Subjects were randomized to one of five arms for a period of six weeks to receive either 100 mg of OBE2109 alone or with one of two ABT doses (E2/NETA: 0.5mg/0.1mg or 1mg/0.5mg), or 200 mg of OBE2109 alone or with the standard dose of ABT (E2/NETA: 1mg/0.5mg). ObsEva observed that OBE2109 at 100 mg and 200 mg doses rapidly reduced E2 to levels that are expected to treat symptoms of UF and EM (see Table 1 below). The marked E2 reduction seen with standalone dosing supports the need for ABT to minimize BMD loss in the 200 mg group, and potentially in some subjects treated with 100 mg. The addition of ABT doses in the study to subjects treated with 100 mg and 200 mg of OBE2109 restored E2 levels to the target range that ObsEva believes would minimize BMD loss. As for the other metric in this clinical trial, the bleeding pattern during the final four weeks of treatment, results were as expected; the vast majority of patients achieved amenorrhea when treated with OBE2109 alone. Notably, the majority of patients in each treatment arm achieved a status of either "amenorrhea," or bleeding characterized as "spotting only," which ObsEva believes demonstrates the benefit of combined OBE2109/ABT (see Table 2 below). However, the rates of bleeding control were lower in treatment arms that included ABT. Table 1:  Median (IQR: 25 - 75%) E2 level after week 1 and 6 of treatment Table 2: Bleeding pattern during the last four weeks of treatment From a safety standpoint, all regimens were well-tolerated and no safety signal emerged. OBE2109 has now been dosed in more than seven hundred (700) women. ObsEva plans to submit detailed results for presentation at a future scientific conference. Uterine fibroids are common non-cancerous tumors that grow within the muscular wall of the uterus. They can vary in size and number and when symptomatic, are most often accompanied by heavy menstrual bleeding, anemia, abdominal pressure and pain, bloating, increased urinary frequency and reproductive dysfunction. Uterine fibroids are associated with an increased risk of pregnancy complications such as infertility, miscarriage, placental abruption and early onset of labor. According to a study published in the American Journal of Obstetrics & Gynecology in 2003, uterine fibroids affect an estimated 20 to 40 percent of women over the age of 30 in the United States based on clinical cases and women who undergo treatment. For the millions of women with symptomatic uterine fibroids seeking treatment options, selection is driven by symptom severity, the woman's age, and her desire to have children now or in the future. While medical, surgical and minimally invasive treatments are available, the standard of care for symptomatic uterine fibroids is a hysterectomy or, in women who wish to preserve their fertility, surgical removal of the fibroid(s). Endometriosis is a disease in which the endometrium (tissue lining the inside of the uterus) grows outside of the uterus, where it induces a chronic inflammatory reaction in the abdomen that may result in scar tissue. It is primarily found on the pelvic peritoneum, on the ovaries, in the rectovaginal septum, on the bladder and in the bowels. The most common symptom of endometriosis is pelvic pain, which often correlates to the menstrual cycle. Patients may also experience painful ovulation, pain during or after sexual intercourse, heavy bleeding, chronic pelvic pain, fatigue and infertility. For many, endometriosis pain can be so severe and debilitating that it impacts do day-to-day activities and has a negative effect on general physical, mental and social well-being. Endometriosis treatments aim first to alleviate pain, then to remove or decrease the size and number of endometrial lesions, and possibly improve fertility. Oral contraceptives, progestins and NSAIDs are generally first-line treatments for women experiencing pain. Following the failure of first-line therapies, current treatment options are limited to intra-muscular or subcutaneous GnRH agonist injections, GnRH agonists nasal spray pumps or surgery (including hysterectomy) for the most symptomatic cases. The World Endometriosis Research Foundation's EndoCost study estimated the aggregate annual cost of endometriosis to be approximately $80 billion in the United States and approximately $60 billion in Germany, the UK, France and Italy in 2012 based on current exchange rates. OBE2109 is a novel, orally administered GnRH receptor antagonist with a potentially best-in-class profile in late-stage clinical development for the treatment of pain associated with endometriosis and heavy menstrual bleeding associated with uterine fibroids. OBE2109 acts by binding to and blocking the GnRH receptor in the pituitary gland, ultimately reducing estrogen production by the ovaries. Through previously reported results from this class of drugs and sophisticated pharmacological modelling, it has been established that maintaining estradiol within a specific target range provides the optimal balance between reducing symptoms while mitigating bone density loss associated with excessive estradiol suppression. ObsEva licensed OBE2109 from Kissei in late 2015 and retains worldwide commercial rights, excluding Asia, for OBE2109. Kissei is a Japanese pharmaceutical company with approximately 70 years of history, specialized in the field of urology, kidney - dialysis and Unmet Medical Needs. Silodosin is a Kissei product for the treatment of the signs and symptoms of benign prostatic hyperplasia which is sold worldwide through its licensees. KLH-2109/OBE2109 is a new chemical entity discovered by Kissei R&D. ObsEva is a clinical-stage biopharmaceutical company focused on the clinical development and commercialization of novel therapeutics for serious conditions that compromise a woman's reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor and improving ART outcomes. ObsEva is listed on The NASDAQ Global Select Market and is trading under the ticker symbol "OBSV". For more information, please visit www.ObsEva.com. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan," "potential," "will," and similar expressions, and are based on ObsEva's current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of OBE2109, including its safety, tolerability and potential for efficacy. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials and related interactions with regulatory bodies, ObsEva's reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of ObsEva's Annual Report on Form 20-F for the year ended December 31, 2016, and other filings ObsEva makes with the SEC from time to time. These documents are available on the Investors page of ObsEva's website at http://www.obseva.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.


- OBE2109 is a GnRH receptor antagonist currently in development as both a stand-alone treatment and with add-back therapy designed to address the needs of endometriosis and uterine fibroid patients - Geneva, Switzerland and Boston, MA - 07 June 2017 - ObsEva SA (Nasdaq: OBSV), a Swiss biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman's reproductive health and pregnancy, today announced the completion of a Phase 1 clinical trial aimed at evaluating the PK/PD relationship of OBE2109 combined with different doses of add-back therapy. OBE2109 is a novel, oral GnRH receptor antagonist that is currently in a Phase 2b clinical trial for the treatment of pain associated with endometriosis (EM) and in Phase 3 clinical trials for the treatment of heavy menstrual bleeding (HMB) associated with uterine fibroids (UF) in pre-menopausal women. Although estrogen (E2) suppression is a well-validated strategy for alleviating symptoms of UF and EM, therapeutic benefit can be compromised by hypo-estrogenic effects, principally bone mineral density (BMD) loss.  This often necessitates administration of add-back therapy (ABT) to patients, which delivers estrogen/progestogens to counteract the deleterious effects of BMD. The ongoing OBE2109 development program is investigating two complementary approaches to achieving what ObsEva believes is the optimal estrogen level to find a balance between efficacy and side effects. The first approach is to use a "low" dose of OBE2109 that targets an E2 range of 20 to 60 pg/mL, without the addition of add-back therapy. The second approach targets maximal E2 suppression with a "high" dose of OBE2109, combined with add-back therapy to bring exogenous E2 back to the desired level that is intended to aid BMD safety. "We are very pleased by the results of this important PK/PD study in which we observed in Caucasian subjects the rapid onset and effectiveness of OBE2109 to reduce E2 levels that was previously reported in Japanese subjects," said Ernest Loumaye, MD, PhD, OB&GYN, CEO and Co-Founder of ObsEva. "We believe there are several important observations from this study that support our ongoing development strategy for OBE2109 as a treatment for EM and UF.  First, the OBE2109 dosages of 100 mg and 200 mg being tested in our ongoing PRIMROSE 1 and PRIMROSE 2 Phase 3 clinical trials, as well as add-back therapy of 1mg/0.5 E2/norethindrone acetate (NETA), appear to be doses that balance the intended therapeutic effect with deleterious side effects.  Second, as demonstrated by the median E2 level of 18 pg/mL following six weeks of dosing with 100 mg of OBE2109, upwards of 50% of patients may not require add-back therapy.  And third, the addition of add-back therapy intended to counteract BMD reduction appears to significantly moderate the potential benefit of GnRH antagonism, in terms of bleeding control as measured by rates of amenorrhea and spotting.  Therefore, we continue to believe that development of two regimens of administration for OBE2109 (with and without ABT) may best address the needs of the EM and UF populations." The present Phase 1 clinical trial reported herein aimed to evaluate the pharmacodynamics, safety, tolerability and pharmacokinetics of the oral GnRH receptor antagonist OBE2109 alone or co-administered with E2/NETA add-back therapy. This was a prospective, randomized, parallel group study involving 76 healthy, Caucasian women of child-bearing potential. Subjects were randomized to one of five arms for a period of six weeks to receive either 100 mg of OBE2109 alone or with one of two ABT doses (E2/NETA: 0.5mg/0.1mg or 1mg/0.5mg), or 200 mg of OBE2109 alone or with the standard dose of ABT (E2/NETA: 1mg/0.5mg). ObsEva observed that OBE2109 at 100 mg and 200 mg doses rapidly reduced E2 to levels that are expected to treat symptoms of UF and EM (see Table 1 below). The marked E2 reduction seen with standalone dosing supports the need for ABT to minimize BMD loss in the 200 mg group, and potentially in some subjects treated with 100 mg. The addition of ABT doses in the study to subjects treated with 100 mg and 200 mg of OBE2109 restored E2 levels to the target range that ObsEva believes would minimize BMD loss. As for the other metric in this clinical trial, the bleeding pattern during the final four weeks of treatment, results were as expected; the vast majority of patients achieved amenorrhea when treated with OBE2109 alone. Notably, the majority of patients in each treatment arm achieved a status of either "amenorrhea," or bleeding characterized as "spotting only," which ObsEva believes demonstrates the benefit of combined OBE2109/ABT (see Table 2 below). However, the rates of bleeding control were lower in treatment arms that included ABT. Table 1:  Median (IQR: 25 - 75%) E2 level after week 1 and 6 of treatment Table 2: Bleeding pattern during the last four weeks of treatment From a safety standpoint, all regimens were well-tolerated and no safety signal emerged. OBE2109 has now been dosed in more than seven hundred (700) women. ObsEva plans to submit detailed results for presentation at a future scientific conference. Uterine fibroids are common non-cancerous tumors that grow within the muscular wall of the uterus. They can vary in size and number and when symptomatic, are most often accompanied by heavy menstrual bleeding, anemia, abdominal pressure and pain, bloating, increased urinary frequency and reproductive dysfunction. Uterine fibroids are associated with an increased risk of pregnancy complications such as infertility, miscarriage, placental abruption and early onset of labor. According to a study published in the American Journal of Obstetrics & Gynecology in 2003, uterine fibroids affect an estimated 20 to 40 percent of women over the age of 30 in the United States based on clinical cases and women who undergo treatment. For the millions of women with symptomatic uterine fibroids seeking treatment options, selection is driven by symptom severity, the woman's age, and her desire to have children now or in the future. While medical, surgical and minimally invasive treatments are available, the standard of care for symptomatic uterine fibroids is a hysterectomy or, in women who wish to preserve their fertility, surgical removal of the fibroid(s). Endometriosis is a disease in which the endometrium (tissue lining the inside of the uterus) grows outside of the uterus, where it induces a chronic inflammatory reaction in the abdomen that may result in scar tissue. It is primarily found on the pelvic peritoneum, on the ovaries, in the rectovaginal septum, on the bladder and in the bowels. The most common symptom of endometriosis is pelvic pain, which often correlates to the menstrual cycle. Patients may also experience painful ovulation, pain during or after sexual intercourse, heavy bleeding, chronic pelvic pain, fatigue and infertility. For many, endometriosis pain can be so severe and debilitating that it impacts do day-to-day activities and has a negative effect on general physical, mental and social well-being. Endometriosis treatments aim first to alleviate pain, then to remove or decrease the size and number of endometrial lesions, and possibly improve fertility. Oral contraceptives, progestins and NSAIDs are generally first-line treatments for women experiencing pain. Following the failure of first-line therapies, current treatment options are limited to intra-muscular or subcutaneous GnRH agonist injections, GnRH agonists nasal spray pumps or surgery (including hysterectomy) for the most symptomatic cases. The World Endometriosis Research Foundation's EndoCost study estimated the aggregate annual cost of endometriosis to be approximately $80 billion in the United States and approximately $60 billion in Germany, the UK, France and Italy in 2012 based on current exchange rates. OBE2109 is a novel, orally administered GnRH receptor antagonist with a potentially best-in-class profile in late-stage clinical development for the treatment of pain associated with endometriosis and heavy menstrual bleeding associated with uterine fibroids. OBE2109 acts by binding to and blocking the GnRH receptor in the pituitary gland, ultimately reducing estrogen production by the ovaries. Through previously reported results from this class of drugs and sophisticated pharmacological modelling, it has been established that maintaining estradiol within a specific target range provides the optimal balance between reducing symptoms while mitigating bone density loss associated with excessive estradiol suppression. ObsEva licensed OBE2109 from Kissei in late 2015 and retains worldwide commercial rights, excluding Asia, for OBE2109. Kissei is a Japanese pharmaceutical company with approximately 70 years of history, specialized in the field of urology, kidney - dialysis and Unmet Medical Needs. Silodosin is a Kissei product for the treatment of the signs and symptoms of benign prostatic hyperplasia which is sold worldwide through its licensees. KLH-2109/OBE2109 is a new chemical entity discovered by Kissei R&D. ObsEva is a clinical-stage biopharmaceutical company focused on the clinical development and commercialization of novel therapeutics for serious conditions that compromise a woman's reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor and improving ART outcomes. ObsEva is listed on The NASDAQ Global Select Market and is trading under the ticker symbol "OBSV". For more information, please visit www.ObsEva.com. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan," "potential," "will," and similar expressions, and are based on ObsEva's current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of OBE2109, including its safety, tolerability and potential for efficacy. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials and related interactions with regulatory bodies, ObsEva's reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of ObsEva's Annual Report on Form 20-F for the year ended December 31, 2016, and other filings ObsEva makes with the SEC from time to time. These documents are available on the Investors page of ObsEva's website at http://www.obseva.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.


- OBE2109 is a GnRH receptor antagonist currently in development as both a stand-alone treatment and with add-back therapy designed to address the needs of endometriosis and uterine fibroid patients - Geneva, Switzerland and Boston, MA - 07 June 2017 - ObsEva SA (Nasdaq: OBSV), a Swiss biopharmaceutical company focused on the development and commercialization of novel therapeutics for serious conditions that compromise a woman's reproductive health and pregnancy, today announced the completion of a Phase 1 clinical trial aimed at evaluating the PK/PD relationship of OBE2109 combined with different doses of add-back therapy. OBE2109 is a novel, oral GnRH receptor antagonist that is currently in a Phase 2b clinical trial for the treatment of pain associated with endometriosis (EM) and in Phase 3 clinical trials for the treatment of heavy menstrual bleeding (HMB) associated with uterine fibroids (UF) in pre-menopausal women. Although estrogen (E2) suppression is a well-validated strategy for alleviating symptoms of UF and EM, therapeutic benefit can be compromised by hypo-estrogenic effects, principally bone mineral density (BMD) loss.  This often necessitates administration of add-back therapy (ABT) to patients, which delivers estrogen/progestogens to counteract the deleterious effects of BMD. The ongoing OBE2109 development program is investigating two complementary approaches to achieving what ObsEva believes is the optimal estrogen level to find a balance between efficacy and side effects. The first approach is to use a "low" dose of OBE2109 that targets an E2 range of 20 to 60 pg/mL, without the addition of add-back therapy. The second approach targets maximal E2 suppression with a "high" dose of OBE2109, combined with add-back therapy to bring exogenous E2 back to the desired level that is intended to aid BMD safety. "We are very pleased by the results of this important PK/PD study in which we observed in Caucasian subjects the rapid onset and effectiveness of OBE2109 to reduce E2 levels that was previously reported in Japanese subjects," said Ernest Loumaye, MD, PhD, OB&GYN, CEO and Co-Founder of ObsEva. "We believe there are several important observations from this study that support our ongoing development strategy for OBE2109 as a treatment for EM and UF.  First, the OBE2109 dosages of 100 mg and 200 mg being tested in our ongoing PRIMROSE 1 and PRIMROSE 2 Phase 3 clinical trials, as well as add-back therapy of 1mg/0.5 E2/norethindrone acetate (NETA), appear to be doses that balance the intended therapeutic effect with deleterious side effects.  Second, as demonstrated by the median E2 level of 18 pg/mL following six weeks of dosing with 100 mg of OBE2109, upwards of 50% of patients may not require add-back therapy.  And third, the addition of add-back therapy intended to counteract BMD reduction appears to significantly moderate the potential benefit of GnRH antagonism, in terms of bleeding control as measured by rates of amenorrhea and spotting.  Therefore, we continue to believe that development of two regimens of administration for OBE2109 (with and without ABT) may best address the needs of the EM and UF populations." The present Phase 1 clinical trial reported herein aimed to evaluate the pharmacodynamics, safety, tolerability and pharmacokinetics of the oral GnRH receptor antagonist OBE2109 alone or co-administered with E2/NETA add-back therapy. This was a prospective, randomized, parallel group study involving 76 healthy, Caucasian women of child-bearing potential. Subjects were randomized to one of five arms for a period of six weeks to receive either 100 mg of OBE2109 alone or with one of two ABT doses (E2/NETA: 0.5mg/0.1mg or 1mg/0.5mg), or 200 mg of OBE2109 alone or with the standard dose of ABT (E2/NETA: 1mg/0.5mg). ObsEva observed that OBE2109 at 100 mg and 200 mg doses rapidly reduced E2 to levels that are expected to treat symptoms of UF and EM (see Table 1 below). The marked E2 reduction seen with standalone dosing supports the need for ABT to minimize BMD loss in the 200 mg group, and potentially in some subjects treated with 100 mg. The addition of ABT doses in the study to subjects treated with 100 mg and 200 mg of OBE2109 restored E2 levels to the target range that ObsEva believes would minimize BMD loss. As for the other metric in this clinical trial, the bleeding pattern during the final four weeks of treatment, results were as expected; the vast majority of patients achieved amenorrhea when treated with OBE2109 alone. Notably, the majority of patients in each treatment arm achieved a status of either "amenorrhea," or bleeding characterized as "spotting only," which ObsEva believes demonstrates the benefit of combined OBE2109/ABT (see Table 2 below). However, the rates of bleeding control were lower in treatment arms that included ABT. Table 1:  Median (IQR: 25 - 75%) E2 level after week 1 and 6 of treatment Table 2: Bleeding pattern during the last four weeks of treatment From a safety standpoint, all regimens were well-tolerated and no safety signal emerged. OBE2109 has now been dosed in more than seven hundred (700) women. ObsEva plans to submit detailed results for presentation at a future scientific conference. Uterine fibroids are common non-cancerous tumors that grow within the muscular wall of the uterus. They can vary in size and number and when symptomatic, are most often accompanied by heavy menstrual bleeding, anemia, abdominal pressure and pain, bloating, increased urinary frequency and reproductive dysfunction. Uterine fibroids are associated with an increased risk of pregnancy complications such as infertility, miscarriage, placental abruption and early onset of labor. According to a study published in the American Journal of Obstetrics & Gynecology in 2003, uterine fibroids affect an estimated 20 to 40 percent of women over the age of 30 in the United States based on clinical cases and women who undergo treatment. For the millions of women with symptomatic uterine fibroids seeking treatment options, selection is driven by symptom severity, the woman's age, and her desire to have children now or in the future. While medical, surgical and minimally invasive treatments are available, the standard of care for symptomatic uterine fibroids is a hysterectomy or, in women who wish to preserve their fertility, surgical removal of the fibroid(s). Endometriosis is a disease in which the endometrium (tissue lining the inside of the uterus) grows outside of the uterus, where it induces a chronic inflammatory reaction in the abdomen that may result in scar tissue. It is primarily found on the pelvic peritoneum, on the ovaries, in the rectovaginal septum, on the bladder and in the bowels. The most common symptom of endometriosis is pelvic pain, which often correlates to the menstrual cycle. Patients may also experience painful ovulation, pain during or after sexual intercourse, heavy bleeding, chronic pelvic pain, fatigue and infertility. For many, endometriosis pain can be so severe and debilitating that it impacts do day-to-day activities and has a negative effect on general physical, mental and social well-being. Endometriosis treatments aim first to alleviate pain, then to remove or decrease the size and number of endometrial lesions, and possibly improve fertility. Oral contraceptives, progestins and NSAIDs are generally first-line treatments for women experiencing pain. Following the failure of first-line therapies, current treatment options are limited to intra-muscular or subcutaneous GnRH agonist injections, GnRH agonists nasal spray pumps or surgery (including hysterectomy) for the most symptomatic cases. The World Endometriosis Research Foundation's EndoCost study estimated the aggregate annual cost of endometriosis to be approximately $80 billion in the United States and approximately $60 billion in Germany, the UK, France and Italy in 2012 based on current exchange rates. OBE2109 is a novel, orally administered GnRH receptor antagonist with a potentially best-in-class profile in late-stage clinical development for the treatment of pain associated with endometriosis and heavy menstrual bleeding associated with uterine fibroids. OBE2109 acts by binding to and blocking the GnRH receptor in the pituitary gland, ultimately reducing estrogen production by the ovaries. Through previously reported results from this class of drugs and sophisticated pharmacological modelling, it has been established that maintaining estradiol within a specific target range provides the optimal balance between reducing symptoms while mitigating bone density loss associated with excessive estradiol suppression. ObsEva licensed OBE2109 from Kissei in late 2015 and retains worldwide commercial rights, excluding Asia, for OBE2109. Kissei is a Japanese pharmaceutical company with approximately 70 years of history, specialized in the field of urology, kidney - dialysis and Unmet Medical Needs. Silodosin is a Kissei product for the treatment of the signs and symptoms of benign prostatic hyperplasia which is sold worldwide through its licensees. KLH-2109/OBE2109 is a new chemical entity discovered by Kissei R&D. ObsEva is a clinical-stage biopharmaceutical company focused on the clinical development and commercialization of novel therapeutics for serious conditions that compromise a woman's reproductive health and pregnancy. Through strategic in-licensing and disciplined drug development, ObsEva has established a late-stage clinical pipeline with development programs focused on treating endometriosis, uterine fibroids, preterm labor and improving ART outcomes. ObsEva is listed on The NASDAQ Global Select Market and is trading under the ticker symbol "OBSV". For more information, please visit www.ObsEva.com. Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. These statements may be identified by words such as "believe", "expect", "may", "plan," "potential," "will," and similar expressions, and are based on ObsEva's current beliefs and expectations. These forward-looking statements include expectations regarding the clinical development of OBE2109, including its safety, tolerability and potential for efficacy. These statements involve risks and uncertainties that could cause actual results to differ materially from those reflected in such statements. Risks and uncertainties that may cause actual results to differ materially include uncertainties inherent in the conduct of clinical trials and related interactions with regulatory bodies, ObsEva's reliance on third parties over which it may not always have full control, and other risks and uncertainties that are described in the Risk Factors section of ObsEva's Annual Report on Form 20-F for the year ended December 31, 2016, and other filings ObsEva makes with the SEC from time to time. These documents are available on the Investors page of ObsEva's website at http://www.obseva.com. Any forward-looking statements speak only as of the date of this press release and are based on information available to ObsEva as of the date of this release, and ObsEva assumes no obligation to, and does not intend to, update any forward-looking statements, whether as a result of new information, future events or otherwise.


The present disclosure relates to an interactive movement detection system applicable to articles of clothing that allows a user to interact with virtualized controllable environments such as the graphical programming environments of personal computers and/or those generated by video game consoles. Similarly, the system of example implementations of the present disclosure allows feedback of actions to the system in the form of impulses that generate pressure and/or vibration sensations that simulate interaction with elements of the controllable interface.


Robson T.S.,Obe Inc
Television Technology in the 80s: 15th Annual SMPTE Television Conference | Year: 2016

In the UK we have lived with a 405-line television system since the first public high definition television service, as it was then called, was inaugurated in 1936. This, like those that were adopted in other countries, such as the 525-line standard originated in the United States and the 625-line standard in Europe, is an analogue system throughout from the signal origination through the studios, links, transmitters and receivers to the display device in the homes. © 1981 Society of Motion Picture and Television Engineers, Inc.


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