firstwordpharmaJuly 01, 2021
Tag: Biophytis , SARA-INT , COVID-19
Biophytis SA (Nasdaq CM: BPTS, Euronext Growth Paris: ALBPS), ("Biophytis" or the "company"),a clinical-stage biotechnology company focused on the development of therapeutics that are aimed at slowing the degenerative processes associated with aging and improving functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19 today announces topline results for SARA-INT phase 2 study will be released in August 2021. The full results with complete details will be presented during the digital ICSFR scientific & medical conference, next September 29-October 2 2021.
The objective of the SARA-INT Phase 2 study is to evaluate the efficacy and safety of Sarconeos (BIO101) in a randomized placebo-controlled study in patients over 65 years suffering from sarcopenia and considered at high risk of mobility disability. The primary endpoint of SARA-INT is patients' mobility disability as measured by the gait-speed over the 400-meter walk test (400MWT).
The multicenter double-blind, interventional study recruited a total of 233 patients in 22 centers in Belgium and the US who were dosed orally at 175 mg b.i.d. and 350 mg b.i.d. with Sarconeos (BIO101) through a 26-week period. 196 of those patients have completed the trial despite the COVID-19 pandemic last December 2020.
Biophytis SA is a clinical-stage biotechnology company specialized in the development of therapeutics that are aimed at slowing the degenerative processes associated with aging and improving functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19. Sarconeos (BIO101), our leading drug candidate, is a small molecule, administered orally, being developed as a treatment for sarcopenia in a Phase 2 clinical trial in the United States and Europe (SARA-INT). It is also being studied in a clinical two-part Phase 2-3 study (COVA) for the treatment of severe respiratory manifestations of COVID-19 in Europe, Latin America, and the US. A pediatric formulation of Sarconeos (BIO101) is being developed for the treatment of Duchenne Muscular Dystrophy (DMD). The company is based in Paris, France, and Cambridge, Massachusetts. The company's common shares are listed on Euronext Growth (Ticker: ALBPS -ISIN:FR0012816825) and ADSs are listed on Nasdaq Capital Market (Ticker BPTS - ISIN: US09076G1040).
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