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BIOPHYTIS: Inclusion of the First Patient in Phase 2b Study in SarcopeniaPreliminary results expected in Q3 2019 PARIS, May 24, 2018 (GLOBE NEWSWIRE) -- BIOPHYTIS (Euronext Growth Paris: ALBPS), a biotechnology company specializing in the development of drug candidates to fight age-related degenerative diseases, today announces the entry and treatment of the first patient in SARA-INT, a Phase 2b clinical trial of its therapeutic-candidate Sarconeos to treat Sarcopenia. Patient recruitment is scheduled to be completed by year-end and preliminary results are scheduled during summer of 2019, with final results around the end of 2019. Stanislas Veillet, CEO of BIOPHYTIS, said: "The entry of the first patient into SARA-INT marks a major potential breakthrough for patients suffering from sarcopenia, a common age-related degenerative disease where there is still no available treatment despite the high risk of loss of mobility. This study will test the efficacy of Sarconeos, the first drug-candidate designed to fight loss of muscle mass and mobility in people with Sarcopenia. Recruitment has started in centers in Belgium and the United States and is scheduled to be complete by the end of the year, which will allow us to report preliminary results in summer of 2019 and final results around the end of 2019." The double-blind, placebo-controlled Phase 2b SARA-INT study will include about 334 patients in 22 clinical centers in Europe (Belgium, France and Italy) and in the United States. About half of the patients will be recruited from an observational study, SARA-OBS, which has been run by BIOPHYTIS at some of the key clinical centers of SARA-INT over the past year. The other half of the patients will be recruited from 11 new clinical centers, which are in the process of opening. The clinical protocol, in particular the inclusion criteria and the main criterion, was defined following the scientific opinion of the European Medicines Agency (EMA) and the comments of the Food & Drug Administration (FDA) in the context of a new experimental drug application (IND). In 2017, the FDA and the Belgian Medicines Agency (AFMPS) gave their agreements to start this study. BIOPHYTIS is still waiting for authorizations from French and Italian drug agencies. The objectives of SARA-INT are to evaluate the safety and efficacy of two doses of Sarconeos (175 mg bid and 350 mg bid) administered orally for 26 weeks against placebo in a population of men and women over 65 with a risk of disability. The SARA program's clinical strategy has been defined so that the SARA-INT study is a continuation of SARA-OBS. SARA-OBS and SARA-INT share governance, inclusion criteria, primary and secondary criteria, the SARA-DATA data management system and CRO ICON Clinical Research. Roger Fielding, Professor at Tufts University in Boston, USA, is the principal investigator of the SARA-INT study and SARA-OBS. A Steering Committee, composed of 4 members representing the two continents participating in the study, was created for the management of these studies. The Steering Committee is chaired by the principal investigator, Professor Roger Fielding. Professor Marco Pahor (University of Florida, Gainesville, FL, USA) is vice-chair. Professors Olivier Bruyère (University of Liège, Belgium) and Yves Rolland (CHU Purpan, Toulouse, France) are the European representatives. About SARA-INT About BIOPHYTIS BIOPHYTIS is listed on the Euronext Growth market of Euronext Paris (ALBPS; ISIN: FR0012816825). For more information: http://www.biophytis.com Follow us on Twitter @biophytis BIOPHYTIS is eligible for the SMEs scheme Disclaimer This press release and the information contained herein do not constitute an offer to sell or a solicitation of an offer to buy or subscribe to shares in BIOPHYTIS in any country. Items in this press release may contain forward-looking statements involving risks and uncertainties. The Company’s actual results could differ substantially from those anticipated in these statements owing to various risk factors which are described in the Company’s prospectus. This press release has been prepared in both French and English. In the event of any differences between the two texts, the French language version shall prevail.
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