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BIOPHYTIS (EPA:ALBPS) - Biophytis Enters into a Collaboration with the French Muscular Dystrophy Association (AFM-Telethon)

Directive transparence : information réglementée Autres communiqués

12/06/2019 07:30

Press release

Biophytis Enters into a Collaboration with the French Muscular Dystrophy
Association (AFM-Telethon)

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

Paris (France), Cambridge (Massachusetts, United States), June 12, 2019 -
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
EUR400,000 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 (EUR89.2 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.
http://www.afm-telethon.com/

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 agerelated 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.

Disclaimer
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.

Biophytis Investor Relations Contact
Daniel Schneiderman, CFO
dan.schneiderman@biophytis.com
Tel: +1 (857) 220-9720

U.S. Media Contact
LifeSci Public Relations
Cherilyn Cecchini, M.D.
ccecchini@lifescipublicrelations.com
Tel: +1 (646) 876-5196

Europe Media Contact
Citigate Dewe Rogerson
Antoine Denry
antoine.denry@citigatedewerogerson.com
Tel: +33 (0) 1 53 32 84 78