SILVER SPRING, MD, United States

Reveragen Biopharma, Inc.

www.reveragen.com
SILVER SPRING, MD, United States

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Patent
Reveragen Biopharma, Inc. | Date: 2016-08-05

The present invention relates to compounds and methods which may be useful as treatments of neuromuscular diseases such as muscular dystrophy, and as inhibitors of NF-B for the treatment or prevention of muscular wasting disease, including muscular dystrophy.


Patent
Reveragen Biopharma, Inc. | Date: 2014-01-27

The present invention relates to compounds and methods which may be useful as treatments of neuromuscular diseases such as muscular dystrophy, and as inhibitors of NF-B for the treatment or prevention of muscular wasting disease, including muscular dystrophy.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: SBIR | Phase: Phase II | Award Amount: 1.50M | Year: 2016

DESCRIPTION provided by applicant ReveraGen BioPharma is a clinical stage drug development company that is developing VBP a novel dissociative steroidal class drug The initial indication for development is Duchenne muscular dystrophy where VBP holds promise for retaining or increasing efficacy of glucocorticoids while reducing side effects bone fragilit stunting of growth VBP is currently in Phase I clinical trials in adult volunteers This proposed Phase II SBIR research is to carry out a Phase IIa clinical trial in Duchenne muscular dystrophy boys steroid na ve ages yrs Aim is to test four dose levels of VBP in a multiple ascending dose MAD trial design with two weeks on drug Patients completing the Phase IIa clinical trial will be offered enrollment into a six month extension study The goal is t test pediatric pharmacokinetics tolerability and safety in the Phase IIa clinical trial and assessments of efficacy time to stand velocity and safety change in body mass index in the six month extension study to aid dose selection in the future Phase IIb registration trial Aim i to develop a pharmacodynamics biomarker panel that can assess safety and efficacy markers in acute time frames from peripheral blood We have completed a natural history of DMD serum biomarkers using both SomaScan and proteomics discovery methods and present preliminary data on glucocorticoid associated efficacy and safety biomarkers The Phase II SBIR research will compare VBP biomarkers to glucocorticoid biomarkers as a means of assessing comparative safety and potential efficacy PUBLIC HEALTH RELEVANCE The proposed Small Business Innovation Research application is to carry out a clinical trial of an innovative steroidal drug VBP in young boys with Duchenne muscular dystrophy VBP shows promise in reducing side effects of glucocorticoids while retaining or increasing efficacy A key innovation is the definition of pharmacodynamic biomarkers for both safety and efficacy with likely application to other drug development programs in the muscular dystrophies


Patent
Reveragen Biopharma, Inc. | Date: 2016-06-29

The present invention relates to compounds and methods which may be useful as treatments of diseases.


Patent
Reveragen Biopharma, Inc. | Date: 2012-11-29

The present invention relates to compounds and methods which may be useful as treatments of diseases.


Patent
Reveragen Biopharma, Inc. | Date: 2015-11-12

The present invention relates to compounds and methods which may be useful as treatments of neuromuscular diseases such as muscular dystrophy, and as inhibitors of NF-B for the treatment or prevention of muscular wasting disease, including muscular dystrophy.


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: STTR | Phase: Phase I | Award Amount: 225.00K | Year: 2015

DESCRIPTION provided by applicant Glucocorticoids GCandapos s such as prednisolone are used frequently to induce remission and treat rheumatoid arthritis RA Despite effectiveness many GC mediated detrimental side effects including osteoporosis and muscle atrophy limit long term chronic treatment of RA patients In addition juvenile arthritis patients suffer from th side effect of significant stunting of linear growth These side effects are believed to be mediated by well described glucocorticoid response element GRE mediated transcriptional properties transactivation whereas efficacy is mediated by transrepression of NFkB pro inflammatory pathways ReveraGen BioPharma has identified a lead compound VBP that is a novel dissociative steroid designed to maintain the anti inflammatory efficacy of traditional steroids through NFkB inhibition and GR translocation yet has lost GRE mediated transcriptional activities leading to much less side effects typically associated with traditional glucocorticoid drugs no osteopenia growth stunting or steroid myopathy Importantly VBP has been shown to reduce inflammatory activity in vivo across multiple murine models of disease Furthermore we have demonstrated in a pilot study that VBP significantly reduces the severity of disease in the collagen antibody induced mouse model of arthritis preliminary data Thus VBP may represent a safer and more effective alternative to traditional glucocorticoids in the treatment of RA where treatment of elderly RA patients may show efficacy with loss of osteopenia and steroid myopathy side effects and loss of growth stunting side effects important in juvenile RA The goal of this STTR research is to extend preclinical evaluation of VBP with a blinded study of efficacy endpoints in a chronic collagen induced mouse model of arthritis CIA using published recommendations for pre clinical studies We hypothesize that VBP treatment after disease onset will result in similar anti inflammatory activity compared to prednisolone but possess a much reduced side effect profile As VBP has already entered Phase clinical trials in adult healthy volunteers transition to RA trials would likely ensure shortly after the successful completion of the proposed STTR grant PUBLIC HEALTH RELEVANCE The goal of this STTR research is to extend preclinical evaluation of VBP with a blinded study of efficacy endpoints in a chronic collagen induced mouse model of arthritis using published recommendations for pre clinical studies VBP may represent a safer and more effective alternative to traditional glucocorticoids in the treatment of rheumatoid arthritis


Grant
Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase I | Award Amount: 225.00K | Year: 2014

? DESCRIPTION (provided by applicant): Glucocorticoids (e.g. prednisolone) are prescribed frequently to treat inflammatory bowel disease (IBD). Despite effectiveness, adverse side effects believed to be caused by GRE-mediated transcriptional propertieslimit long term use of glucocorticoids in IBD patients. Furthermore, these GRE-mediated transcriptional activities have been previously shown to be responsible for glucocorticoid-induced impaired healing of the intestinal epithelium. This may explain whyglucocorticoids do not appear to be effective in maintaining remission of disease. ReveraGen BioPharma has identified a novel dissociative steroidal compound (VBP15) designed that retains the anti-inflammatory efficacy of traditional steroids (via NFkB inhibition), but has lost GRE-mediated transcriptional activities. VBP15 treatment has been shown to reduce inflammatory activity in vivo in multiple models of disease including the TNBS-induced mouse model of colitis (preliminary data) and result in a much m


Grant
Agency: Department of Health and Human Services | Branch: | Program: STTR | Phase: Phase I | Award Amount: 225.00K | Year: 2014

DESCRIPTION (provided by applicant): The treatment of pain in Sickle Cell Disease (SCD) is challenging for both patients and providers and is associated with significant disparities in healt care delivery. While the role of ongoing inflammation during vasooclusive crisis and pain is recognized, effective therapeutic interventions are lacking. Glucocorticoids, with their anti-inflammatory properties, in small clinical trials have been shown to reduce the duration of analgesic therapy in children with pain crisis, and in SCD patients admitted with acute chest syndrome, a course of dexamethasone decreased hospitalization time. However, clinicians hesitate to prescribe steroids to treat steroid-responsive conditions in SCD patients because their use is associated with complications that include increased risk of hospital readmission, rebound pain, strokes, avascular necrosis, and acute chest syndrome. Further, some steroid-responsive conditions such as asthma have a high incidence in SCD; however, because of


Grant
Agency: Department of Health and Human Services | Branch: National Institutes of Health | Program: STTR | Phase: Phase I | Award Amount: 253.80K | Year: 2016

DESCRIPTION provided by applicant Glucocorticoids GCandapos s such as prednisolone are used frequently to induce remission and treat multiple sclerosis MS Despite effectiveness many GC mediated detrimental side effects including osteoporosis and muscle atrophy limit long term chronic treatment of MS patients These side effects are believed to be mediated by well described glucocorticoid response element GRE mediated transcriptional properties transactivation whereas efficacy is mediated by trans repression of NFkB pro inflammatory pathways ReveraGen BioPharma has identified a lead compound VBP that is a novel dissociative steroid designed to maintain the anti inflammatory efficacy of traditional steroids through NFkB inhibition and GR translocation yet has lost GRE mediated transcriptional activities leading to much less side effects typically associated with traditional glucocorticoid drugs no osteopenia growth stunting or steroid myopathy Importantly VBP has been shown to reduce inflammatory activity in vivo across multiple murine models of disease Furthermore we have demonstrated in a pilot study that VBP significantly reduces the severity of disease in the experimental autoimmune encephalomyelitis EAE model of multiple sclerosis preliminary data Thus VBP may represent a safer and more effective alternative to traditional glucocorticoids in the treatment of MS The goal of this STTR research is to extend preclinical evaluation of VBP by assessing the effect of treatment on disease in the mouse chronic relapsing remitting EAE model using published recommendations for pre clinical studies We hypothesize that VBP treatment after disease onset will result in similar anti inflammatory activity compared to prednisolone but possess a much reduced side effect profile As VBP has already entered Phase clinical trials in adult healthy volunteers transition to MS trials would likely ensure shortly after the successful completion of the proposed STTR grant PUBLIC HEALTH RELEVANCE The goal of this STTR research is to extend preclinical evaluation of VBP with a blinded study of efficacy endpoints in the relapsing remitting experimental autoimmune encephalomyelitis mouse model of multiple sclerosis using published recommendations for pre clinical studies VBP may represent a safer and more effective alternative to traditional glucocorticoids in the treatment of multiple sclerosis

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