BIOPHYTIS (EPA:ALBPS) - Biophytis Files IND Application with FDA for Sarconeos (BIO101) to Support Planned MYODA Clinical Program in Patients with DMD
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Biophytis Files IND Application with FDA for Sarconeos (BIO101) to Support
Planned MYODA Clinical Program in Patients with DMD
Paris (France), Cambridge (Massachusetts, U.S.), November 15, 2019, 8:00 a.m.
CET - Biophytis SA (Euronext Growth Paris: ALBPS), a clinical-stage
biotechnology company with a primary focus on the treatment of neuromuscular
diseases, announces it has filed an Investigational New Drug (IND) Application
with the US Food and Drug Administration (FDA), which if granted, would allow
it to begin the MYODA clinical development program with Sarconeos (BIO101) in
patients with Duchenne muscular dystrophy (DMD) in 2020. The Company plans to
file similar clinical trial applications to the applicable regulatory agencies
in Europe before the year end.
Biophytis' proposed MYODA clinical program is based on a seamless trial design
from Phase 1 to 3 and a composite score to assess the safety and efficacy of a
pediatric formulation of Sarconeos (BIO101) for both ambulatory and
non-ambulatory patients with DMD.
Stanislas Veillet, Chief Executive Officer, stated: "This IND filing is another
key milestone in Biophytis' strategy to maximize the clinical utility of
Sarconeos (BIO101) in patients with neuromuscular disease. Based on the
pre-clinical data we have generated, we believe that Sarconeos (BIO101) could
become an important new treatment option for patients with DMD. Our MYODA
clinical program incorporate a seamless trial design that aims to clearly
demonstrate the functional, including respiratory, benefits that Sarconeos
(BIO101) could deliver to this underserved patient population."
In June 2019, Biophytis and AMF-Telethon entered a collaboration agreement for
the development of Sarconeos (BIO101) for the treatment of DMD.
Biophytis is a clinical-stage biotechnology company focused on developing
therapeutics that slow the degenerative processes associated with aging and
improve functional outcomes for patients suffering from age-related diseases,
with a primary focus on neuromuscular diseases.
Biophytis' lead drug candidate, Sarconeos (BIO101), is an orally administered
small molecule, which is currently in a Phase 2b clinical trial for sarcopenia
(SARA-INT) in the U.S. and Europe. A pediatric formulation of Sarconeos
(BIO101) is being developed for the treatment of Duchenne muscular dystrophy
(DMD). Biophytis expects to begin the MYODA clinical program in patients with
DMD in 2020, subject to regulatory approval. Biophytis' preclinical drug
candidate, Macuneos (BIO201), is an orally administered small molecule in
development for the treatment of retinopathies, 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
This press release contains certain forward-looking statements. Although the
Company believes its expectations are based on reasonable assumptions, these
forward-looking statements are subject to numerous risks and uncertainties,
which could cause actual results to differ materially from those anticipated.
For a discussion of risks and uncertainties which could cause the Company's
actual results, financial condition, performance or achievements to differ from
those contained in the forward looking statements, please refer to the Risk
Factors ("Facteurs de Risque") section of the Listing Prospectus upon the
admission of Company's shares for trading on the regulated market Euronext
Growth of Euronext Paris filed with the AMF, which is available on the AMF
website (www.amf- france.org) or on Biophytis' website (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
Tel: +1 (857) 220-9720
French and International Media Contact
Citigate Dewe Rogerson
Sylvie Berrebi / Nathaniel Dahan / David Dible/ Quentin Dussart
Tel: +44 (0)20 76389571 / +33 (0)1 55 30 70 91