Biophytis presents the development of Sarconeos (BIO101)
in Phase 3 in the treatment of Sarcopenia
at 15th international SCWD congress
Paris, France, Cambridge (Massachusetts, United States), June 27, 2022 – 11:00 p.m. – Biophytis SA (Nasdaq CM: BPTS, Euronext Growth Paris: ALBPS), (“Biophytis” or the “Company”), a clinical-stage biotechnology company specializing in the development of treatments that aim to slow the degenerative processes associated with aging and to improve functional outcomes for patients with age-related diseases, announces today that it is delivering an oral presentation on the development of Sarconeos (BIO101) for the treatment of sarcopenia in the 15th SCWD International 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” resumes the main stages of development of Sarconeos (BIO101) already reached, mainly the results of the Phase 2 study of SARA-INT, as well as the outline of Phase 3 that the Company intends to initiate before the end of 2022.
On the strength of the results of Phase 2 of SARA-INT and in the continuity of this, the Company has requested the scientific opinion of the European (EMA) and American (FDA) regulatory authorities in order to define the design and the start-up conditions. of phase 3 of the SARA program. Sarconeos (BIO101) has the potential to be the first drug candidate to enter Phase 3 in sarcopenia.
The recent publication of the first results of the European SPRINTT study, a pan-European clinical study in elderly patients with sarcopenia, has provided new data which supports the design of a Phase 3 in this indication. The SPRINTT study has shown, confirming an earlier LIFE study in the United States, that the risk of motor disability can be assessed in patients with severe sarcopenia by measuring the loss of walking ability over a period of 1 to 3 years. over 400m.
Sarconeos Phase 3 (BIO101) will target 600 to 900 patients over the age of 65 with severe sarcopenia (3 ≤ SPPB ≤ 7) with low walking speed (Gait speed (4m) ≤ 0.8 m/s) and low grip strength (HGS < 20 kg for women and < 35.5 kg for men).
Patients will be treated for a minimum of 12 months receiving either placebo or 350mg of Sarconeos (BIO101) bid
The main criterion will be the ability to perform the 400m walk test in less than 15 minutes. To this main criterion will be added the following secondary criteria : walking speed (Gait speed 4-m from SPPB), grip strength (HGS) and patient-reported outcome (Patient Reported Outcome).
The duration of this study is estimated at 36 months from the inclusion of the first patient expected at the end of 2022.
However, the design of this study could change depending on the discussions currently underway with European and American health authorities. The Company intends to file a clinical trial application (CTA) in the fourth quarter of 2022, depending on final discussions with the FDA and EMA.
Stanislas Veillet, CEO of Biophytis, declares : “ Sarcopenia has only very recently been recognized as a diagnosable disease, with no effective treatment option, despite 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 sufficient corroborating data to launch for the first time a phase 3 program in patients with sarcopenia. . We are currently in discussions with European and American health authorities to finalize the design of the SARA Phase 3 program and hope to be able to move forward with a clinical trial application before the end of the year. No drug is currently approved worldwide for sarcopenia, we are pioneers in this field and intend to continue to establish our leadership by being the first company to launch a phase 3 program. »
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About BIOPHYTIS
Biophytis SA is a clinical-stage biotechnology company specializing in the development of treatments that aim to slow the degenerative processes associated with aging and improve the functional outcomes of patients suffering from age-related diseases, including respiratory failure in patients with COVID-19. Sarconeos (BIO101), our lead drug candidate, is an orally administered small molecule that has completed its Phase 2 clinical study in the United States and Europe (SARA-INT) in the treatment of sarcopenia. It is also being studied in a two-part Phase 2/3 (COVA) clinical study for the treatment of severe respiratory manifestations of COVID-19 in Europe, Latin America and the United States. A pediatric formulation of Sarconeos (BIO101) is being developed for the treatment of Duchenne muscular dystrophy.
The company is based in Paris, France, and Cambridge, Massachusetts in the United States. The company’s ordinary shares are listed on the Euronext Growth Paris market (Ticker: ALBPS -ISIN: FR0012816825) (Ticker: ALBPS -ISIN: FR0012816825), and the ADSs are listed on the Nasdaq Capital Market (Ticker BPTS – ISIN: US09076G1040 ).
For more information : www.biophytis.com
Warning
This press release contains forward-looking statements. Forward-looking statements include all statements that are not historical facts. In some cases, you can identify these forward-looking statements by the use of words such as “outlook”, “believe”, “expect”, “potential”, “continue”, “may”, “will”, “should”. “, “could”, “seek”, “predict”, “intend”, “trend”, “plan”, “estimate”, “anticipate” or the negative version of these words or other comparable words. These forward-looking statements include statements regarding Biophytis’ anticipated timing for its Part 1 interim analysis and the release of full study results. These forward-looking statements are based on assumptions that Biophytis believes are reasonable. However, there is no guarantee that the statements contained in these forward-looking statements will be verified, which are subject to various risks and uncertainties, including delays in recruitment or retention of patients, interruptions in the supply or chain of supply, the ability of Biophytis to obtain the necessary regulatory approvals, delays related to COVID-19 and the impact of the current pandemic on the Company’s clinical trials. The forward-looking statements contained in this press release are also subject to risks not yet known to Biophytis or considered insignificant by Biophytis. Accordingly, there are or will be important factors that could cause actual results to differ materially from those indicated in such statements. Please also refer to the “Risks and Uncertainties Facing the Company” section of the Company’s 2021 Annual Report and the “Risk Factors” section of Form 20-F and other forms to be filed respectively with the AMF and the SEC (Securities and Exchange Commission, USA). We undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise, except as required by law.
Contact Biophytis for Investor Relations
Philippe Rousseau, CFO
Media contacts
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