BIO101 in development for the treatment of Sarcopenia

Biophytis presents the development of Sarconeos (BIO101) in Phase 3 for the treatment of Sarcopenia at the 15th SCWD International Congress

Biophytis announced that it is giving an oral presentation on the development of Sarconeos (BIO101) for the treatment of sarcopenia at the 15th International SCWD Congress (Society on Sarcopenia, Cachexia & Wasting disorders).

This oral presentation given by Drs. Waly Dioh and Cendrine Tourette and entitled: “BIO101 in development for the treatment of Sarcopenia” summarises the major milestones in the development of Sarconeos (BIO101) that have already been achieved, mainly the results of the SARA-INT Phase 2 study as well as the outline of SARA Phase 3 study that the Company intends to initiate before the end of 2022.

Building on the results of SARA-INT Phase 2 study, the company has asked for scientific advice from the European (EMA) and American (FDA) regulatory authorities in order to define the design and conditions to start the SARA Phase 3 program. Sarconeos (BIO101) has the potential to be the first drug candidate ever moving into Phase 3 in Sarcopenia.

The recent publication of the first results of European SPRINTT study, a pan-European clinical study in elderly patients with sarcopenia, has provided new data that support the design of a phase 3 in this indication. SPRINTT study showed, confirming prior LIFE study in the USA, that the risk of mobility disability can be estimated in patients with severe sarcopenia by measuring over a period of 1 to 3 years the loss of the ability to walk 400 m.

The Phase 3 study of Sarconeos (BIO101) will target 600 to 900 patients over 65 years old with severe sarcopenia (3 ≤ SPPB ≤ 7), low gait speed (4m) ≤ 0.8 m/s and low Hand Grip Strength (HGS < 20kg for females and < 35.5 kg for males).

Patients will be treated for a minimum of 12 months receiving either placebo or 350mg Sarconeos (BIO101) b.i.d.

The primary endpoint will be the ability to complete the 400m walk test in less than 15 minutes, and the following secondary endpoints will be used: Gait speed 4-m from SPPB, Hand Grip Strength (HGS) and Patient Reported Outcome (PRO).

The duration of this study is estimated at 36 months from the inclusion of the first patient expected at the end of 2022.

The design of this study may however evolve depending on the discussions currently underway with the European and American health authorities. The company intends to file for Clinical Trial Application (CTA) in Q4 2022, depending on final discussions with FDA and EMA.

Stanislas Veillet, CEO of Biophytis, states: “Sarcopenia has only been very recently recognized as a disease that can be diagnosed with no efficient treatment option despites the huge medical need. The recent publication of the first results of the European SPRINTT study, together with the results of the LIFE study in the United States, now provide enough supportive data to initiate for the first time a phase 3 program in patients with sarcopenia. We are currently discussing with the European and American health authorities to finalize the design of the SARA Phase 3 program and hope we could move forward with clinical trial application before the end of the year. No drug is currently approved for sarcopenia in the world, we are pioneers in this field and intend to continue to establish our leadership position by being the first company to initiate a Phase 3 program.”