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HALLE (SAALE), Germany,  8 December  2016 - Probiodrug AG (Euronext Amsterdam: PBD), a biopharmaceutical company developing novel therapeutic solutions to treat Alzheimer's disease (AD), announced today that the study design of the ongoing Phase IIa SAPHIR trial comparing PQ912 to placebo will be presented as a poster on Thursday, December 8, 2016 at the  9th Clinical Trials on Alzheimer's disease (CTAD) meeting in San Diego, USA. The SAPHIR study is a 3 month study in treatment naïve patients with early AD. PQ912 targets the inhibition of the Glutaminylcyclase (QC) resulting in a reduction of the production of neurotoxic pyroGlu-Abeta (pGlu-Abeta) and related oligomers. PQ912 has been extensively investigated in Phase 1 Multiple ascending dose studies (MAD) showing good tolerability and a dose dependent QC-inhibition in the spinal fluid. The SAPHIR study has been designed and is conducted in collaboration with Philip Scheltens, M.D., Ph.D., the VUmc Amsterdam (NL) and the CRO Julius Clinical ( NL). The primary objective of the SAPHIR study is to investigate the safety of PQ912 in the target population and the secondary objective is to assess the pharmacodynamic profile. The publication at CTAD reveals that the study applies a series of methodological innovations which in this combination has not been executed before in an early AD study. Specific in and exclusion criteria based on diagnostic biomarkers of Abeta and tau were required to be met by all patients to ensure a high confidence of the diagnosis of early AD. Mini-Mental State Examination (MMSE) and Cogstate test battery assessments at baseline are monitored blindly every 30 patients to ensure consistency and reliability of ratings. A number of exploratory endpoints like EEG, fMRI and a series of CSF based biomarkers including QC-activity, pGlu-Abeta, Abeta oligomers, neurogranin as well as  inflammation markers are centrally analysed. Based on an exploratory analysis of 86 randomised patients, a low standard deviation for the Neuro-psychological test battery and functional EEG at baseline has been observed. Prof Philip Scheltens, Director of the Alzheimer Center at the VUmc  in Amsterdam and Chairman of the SAPHIR study, said: "The combination of in and exclusion criteria together with the primary and innovative exploratory outcome parameter in the SAPHIR study is unique for an early AD study. We are excited to see the full results in the second quarter of 2017." For more information, please contact: Notes to Editors: About Probiodrug AG Headquartered in Halle (Saale), Germany, Probiodrug AG (Euronext Amsterdam: PBD) is a biopharmaceutical company focused on the development of new therapeutic products for the treatment of Alzheimer's disease. Founded in 1997, the company successfully developed a novel therapeutic concept for diabetes - the DP4 inhibitors - which provided the basis for a novel class of antidiabetics - the gliptins. Its core capabilities are based on its long-standing expertise in the elucidation of the structure and function of enzymes involved in the modification of proteins and peptides, which play a central role in pathological conditions. Today Probiodrug's aim is to become a leading company in the development of Alzheimer's disease treatments and to thereby provide a better life for Alzheimer's disease patients. It has identified a new therapeutic concept linked to disease initiation and progression. The development approaches are targeting pyroglutamate-Abeta (pGlu-Abeta) as a therapeutic strategy to fight Alzheimer's disease. The Company has medical use and composition of matter patents related to the inhibition of Glutaminyl Cyclase (QC) and anti-pGlu-Abeta- specific monoclonal antibodies, providing it, in the Company's view, with a leading position in this field of research. Probiodrug's lead product candidate, PQ912, is a highly specific and potent inhibitor of Glutaminyl Cyclase (QC), which has shown therapeutic effects in Alzheimer's animal models. PQ912 is currently in a Phase 2a study, the SAPHIR trial. In a preceding Phase 1 study with healthy young and elderly volunteers, PQ912 has shown to be safe and well tolerated and also revealed high QC-inhibition. About Alzheimer's disease Alzheimer's disease is a neurological disorder, which is the most common form of dementia, and ultimately leads to death. Because Alzheimer's disease cannot be cured and is degenerative, the affected patients must increasingly rely on others for assistance. . Today, 47 million people live with dementia worldwide, and this number is projected to treble to more than 131 million by 2050, as populations age. Dementia also has a huge economic impact. Alzheimer's has an estimated, global societal cost of US$ 818 billion, and it will become a trillion dollar disease by 2018. (World Alzheimer Report 2016). Forward Looking Statements Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgment of Probiodrug AG as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.

Bonten M.J.M.,University Utrecht | Huijts S.M.,University Utrecht | Bolkenbaas M.,University Utrecht | Webber C.,Pfizer | And 26 more authors.
New England Journal of Medicine | Year: 2015

Background Pneumococcal polysaccharide conjugate vaccines prevent pneumococcal disease in infants, but their efficacy against pneumococcal community-acquired pneumonia in adults 65 years of age or older is unknown. Methods In a randomized, double-blind, placebo-controlled trial involving 84,496 adults 65 years of age or older, we evaluated the efficacy of 13-valent polysaccharide conjugate vaccine (PCV13) in preventing first episodes of vaccine-type strains of pneumococcal community-acquired pneumonia, nonbacteremic and noninvasive pneumococcal community-acquired pneumonia, and invasive pneumococcal disease. Standard laboratory Methods and a serotype-specific urinary antigen detection assay were used to identify community-acquired pneumonia and invasive pneumococcal disease. Results In the per-protocol analysis of first episodes of infections due to vaccine-type strains, community-acquired pneumonia occurred in 49 persons in the PCV13 group and 90 persons in the placebo group (vaccine efficacy, 45.6%; 95.2% confidence interval [CI], 21.8 to 62.5), nonbacteremic and noninvasive community-acquired pneumonia occurred in 33 persons in the PCV13 group and 60 persons in the placebo group (vaccine efficacy, 45.0%; 95.2% CI, 14.2 to 65.3), and invasive pneumococcal disease occurred in 7 persons in the PCV13 group and 28 persons in the placebo group (vaccine efficacy, 75.0%; 95% CI, 41.4 to 90.8). Efficacy persisted throughout the trial (mean follow-up, 3.97 years). In the modified intention-totreat analysis, similar efficacy was observed (vaccine efficacy, 37.7%, 41.1%, and 75.8%, respectively), and community-acquired pneumonia occurred in 747 persons in the PCV13 group and 787 persons in placebo group (vaccine efficacy, 5.1%; 95% CI,-5.1 to 14.2). Numbers of serious adverse events and deaths were similar in the two groups, but there were more local reactions in the PCV13 group. Conclusions Among older adults, PCV13 was effective in preventing vaccine-type pneumococcal, bacteremic, and nonbacteremic community-acquired pneumonia and vaccinetype invasive pneumococcal disease but not in preventing community-acquired pneumonia from any cause. © 2015 Massachusetts Medical Society. All rights reserved.

Janssen A.M.,Wageningen University | Kremer S.,Wageningen University | van Stipriaan W.L.,Julius Clinical | van Stipriaan W.L.,Wageningen University | And 3 more authors.
Journal of the Academy of Nutrition and Dietetics | Year: 2015

Background: Processed foods are major contributors to excessive sodium intake in Western populations. We investigated the effect of food reformulation on daily dietary sodium intake. Objective: To determine whether uninformed consumers accept reduced-sodium lunches and to determine the effect of consuming reduced-sodium lunches on 24-hour urinary sodium excretion. Design: A single-blind randomized controlled pretest-posttest design with two parallel treatment groups was used. Participants/setting: Participants chose foods in an experimental real-life canteen setting at the Restaurant of the Future in Wageningen, the Netherlands, from May 16 until July 1, 2011. Intervention: After a run-in period with regular foods for both groups, the intervention group (n=36) consumed foods with 29% to 61% sodium reduction (some were partially flavor compensated). The control group (n=38) continued consuming regular foods. Main outcome measures: Outcomes for assessment of acceptance were the amount of foods consumed, energy and sodium intake, remembered food liking, and intensity of sensory aspects. Influence on daily dietary sodium intake was assessed by 24-hour urinary sodium excretion. Statistical analyses performed: Between and within-subject comparisons were assessed by analysis of covariance. Results: Energy intake and amount consumed of each food category per lunch remained similar for both groups. Compared with the control group, the intervention group's sodium intake per lunch was significantly reduced by -1,093 mg (adjusted difference) (95% CI -1,285 to -901), equivalent to 43 mmol sodium. Remembered food liking, taste intensity, and saltiness were scored similarly for almost all of the reduced-sodium foods compared with the regular foods. After consuming reduced-sodium lunches, compared with the control group, intervention participants' 24-hour urinary sodium excretion was significantly lower by -40 mEq (adjusted difference) (95% CI -63 to -16) than after consuming regular lunches, and this reflects a decreased daily sodium intake of 1 g. Conclusions: Comparing the two treatment groups, consumption of reduced-sodium foods over a 3-week period was well accepted by the uninformed participants in an experimental real-life canteen setting. The reduced-sodium foods did not trigger compensation behavior during the remainder of the day in the intervention group compared with the control group, as reflected by 24-hour urinary sodium excretion. Therefore, offering reduced-sodium foods without explicitly informing consumers of the sodium reduction can contribute to daily sodium intake reduction. © 2015 Academy of Nutrition and Dietetics.

Smorenburg A.J.,Julius Clinical | Oosterman B.J.,Julius Clinical | Grobbee D.E.,Julius Clinical | Grobbee D.E.,University Utrecht | And 2 more authors.
Vaccine | Year: 2014

Large-scale randomized studies generate the highest level evidence for medical interventions. Yet, successful recruitment frequently is challenging, especially when targeting elderly populations. Although several studies investigated specific recruitment barriers, there is little quantitative understanding of such barriers. We therefore determined associations between patient related and study-related factors and study inclusion in healthy elderly (>65 years) invited to participate in a double-blind placebo-controlled randomized study to determine effectiveness and safety of a 13-valent pneumococcal vaccine for community-acquired pneumonia in the Netherlands. Inclusions for this study took place between September 2008 and January 2010. The analysis was performed on replies to invitations sent between February 2009 and October 2009. In our analyses 260,700 replies from this period resulted in 48,982 candidates included in the study (18.8%). Study inclusion was associated with travel time to the vaccination site (decline of 0.6% per 4. min travel time, adjusted odds ratio (OR) 0.972, 95% CI 0.964-0.980), number of published advertorials in local newspapers (increase of 0.4% per consecutively placed advertorial, adjusted OR 1.030, 95% CI 1.026-1.035), age (decline of 0.7% per year, adjusted OR 0.953, 95% CI 0.951-0.955) and male gender (adjusted OR 0.588 versus female, 95% CI 0.576-0.599). Introduction letters sent on behalf of general practitioners prior to the actual invitation letter were not associated with study inclusion. Careful consideration of these parameters in study preparation may facilitate more successful patient recruitment in clinical trials in healthy elderly. © 2014 Elsevier Ltd.

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