• Provides funding for additional preclinical experiments and for the MYODA preparations for the clinical study in Duchenne muscular dystrophy (DMD)

PARIS and CAMBRIDGE, Mass., June 13, 2019 (GLOBE NEWSWIRE) -- Biophytis SA (Euronext Growth Paris: ALBPS), a clinical-stage biotechnology company focused on the development of therapeutics for age-related diseases, today announced that it has entered into a collaboration agreement effective as of June 03, 2019 with AFM-Telethon focusing on the development of its lead drug candidate, Sarconeos (BIO101) for the treatment of Duchenne Muscular Dystrophy (DMD) through its MYODA clinical program.

Under the terms of the collaboration, AFM-Telethon will provide funding of €400,000 to Biophytis for certain additional preclinical studies and for the preparations for the MYODA clinical program, which may become repayable under certain circumstances.

Subject to regulatory approval to conduct the MYODA clinical trial in Europe and conclusive results from the collaboration, Biophytis will submit to AFM-Telethon a new research project for further collaboration within the framework of the MYODA clinical program.

“We are very pleased to have the support of AFM-Telethon for the development of Sarconeos (BIO101) in DMD through our MYODA clinical program which, subject to regulatory approval, intends to utilize a ‘seamless’ clinical trial design with a composite score combining muscle strength, mobility and respiratory outcomes. DMD is a severe, genetic neuromuscular disease with limited treatment options. Our goal is to provide a safe and effective treatment option for both ambulatory and non-ambulatory patients suffering from this devastating disease regardless the genetic mutation. We are proud to collaborate with AFM-Telethon to help us with our clinical efforts and to make the greatest possible impact for DMD patients and the DMD community,” said Dr. Stanislas Veillet, chief executive officer of Biophytis.

About the MYODA clinical program
Biophytis is preparing to advance an oral pediatric formulation of Sarconeos (BIO101) for Duchenne muscular dystrophy (DMD) into the clinical phases through its MYODA program. The MYODA clinical program has been designed to address development challenges in rare diseases and aims to accommodate the needs of DMD patients while maximizing clinical efficiency. Subject to regulatory approval, it proposes to incorporate two innovative clinical features: (i) a seamless trial design that allows patients to participate across multiple clinical phases (Phase 1 through Phase 3), and (ii) a primary endpoint defined as a composite score combining muscle strength, mobility, and respiratory outcomes, which is adapted to the stage of severity of the disease in each patient.

About AFM-Telethon
AFM-Téléthon is an association of patients and their relatives, committed to fighting disease. Thanks to donations from the Téléthon (€89.2 million in 2017), it has become a major player in biomedical research into rare diseases in France and across the world. Today, it supports clinical trials testing treatments for genetic diseases of the eyes, blood, brain, immune system and muscles. It is unlike other associations in that its laboratories (Genethon, Institut de Myologie, I-Stem) have the ability to design, produce and test their own innovative therapies.


About Biophytis
Biophytis is a clinical-stage biotechnology company focused on the development of therapeutics that slow the degenerative processes and improve functional outcomes for patients suffering from age-related diseases. Our therapeutic approach is aimed at targeting and activating key biological resilience pathways that can protect against and counteract the effects of the multiple biological and environmental stresses that lead to age-related diseases. Our lead drug candidate, Sarconeos (BIO101), is an orally administered small molecule in development for the treatment of neuromuscular diseases, including sarcopenia and Duchenne muscular dystrophy (DMD). Our second drug candidate, Macuneos (BIO201), is an orally administered small molecule in development for the treatment of retinal diseases, including dry age-related macular degeneration (AMD) and Stargardt disease. Biophytis is headquartered in Paris, France, and has offices in Cambridge, Massachusetts. The Company’s ordinary shares are listed on Euronext Growth Paris (Ticker: ALBPS - ISIN: FR0012816825). For more information please visit www.biophytis.com.

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,” “believes,” "expects,” “potential,” “continues,” “may,” “will,” "should," "could," "seeks," "predicts," "intends," "trends," "plans," "estimates," "anticipates" or the negative version of these words or other comparable words. These forward-looking statements include any statements regarding our clinical development plans and future collaborations with AFM-Telethon.  For a discussion of the risks and uncertainties that could cause the Company's actual results, financial condition, performance or achievements to differ from those contained in the Company’s forward looking statements, please consult the Risk Factors section of the Company's registration document and other regulatory filings filed with the French Autorité des Marchés Financiers (AMF), which are available on the AMF website (www.amf-france.org) and at www.biophytis.com. 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 securities of Biophytis in any country. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements and estimates, which speak only as of the date hereof. Other than as required by applicable law, Biophytis undertakes no obligation to update or revise the information contained in this press release. 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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