Biophytis Reports H1 2021 Financial Results and Provides Business Update - Seite 3

Operational Update

• SARA clinical program in sarcopenia. On August 2, 2021, Biophytis announced top line results of the SARA-INT phase 2 clinical study with Sarconeos (BIO101) in Sarcopenia.
  
  Sarconeos (BIO101) at the highest dose (350 mg bid) showed a clinically meaningful improvement in the 400-meter walk test (400MWT), the primary endpoint of the study. Sarconeos (BIO101) also showed a very good safety profile at the doses of 175 mg bid and of 350 mg bid with no Serious Adverse Events (AE) related to the product.
  
  The results of Sarconeos (BIO101) on the 400MWT as the primary endpoint are promising since no other alternative treatment exists as of today. This paves the way towards an upcoming confirmatory phase 3 study in sarcopenia and allows further development of Sarconeos (BIO101) in this indication.
  
  This is a key milestone for Biophytis after 15 years of research and development with Sorbonne University.

• Phase 2/3 COVA study for acute respiratory failure associated with COVID-19. On September 10 2021, the Data Monitoring Committee (DMC) recommended to continue the Phase 2-3 COVA study without any modification of the protocol after the Interim Analysis 2 found efficacy results in the promising zone, based on 155 COVID-19 patients hospitalized with respiratory failure. This recommendation completes previous safety evaluation performed by DMC last August that confirmed the good safety profile of Sarconeos (BIO101).
  
  As of September 15, 35 clinical centers are opened to recruit COVID-19 patients in the USA, Brazil, France and Belgium. 200 patients are randomized in COVA trial to this date.
  
  15 additional sites will be opened to accelerate recruitment in USA, Brazil, France, UK and Belgium, where the COVA study is already approved.
  
  With this new network of 50 sites, top line results of the study are expected in Q1 2022, depending on the evolution of the pandemic.
  
  On June 30, 2021, Biophytis announced it had secured contracts with a major global Custom Development and Manufacturing Organization (CDMO) for the manufacturing of registration batches of Sarconeos (BIO101). These contracts were signed in preparation of the potential filing of the product in COVID-19 for Emergency Use Authorization with the FDA, and/or Conditional Marketing Authorization with the EMA.

• MYODA clinical program in Duchenne muscular dystrophy (DMD). Following Biophytis' receipt of the Investigational New Drug Application obtained from the FDA and authorization from the Belgian authorities in early 2020, the study was delayed due to the COVID-19 pandemic.