BIOPHYTIS (EPA:ALBPS) - Biophytis to Present Four Posters at the 24th Annual Congress of the World Muscle Society (WMS) in Copenhagen, Denmark

Transparency directive : regulatory news

02/10/2019 08:00

Press release

  Biophytis to Present Four Posters at the 24th Annual Congress of the World
                 Muscle Society (WMS) in Copenhagen, Denmark

Paris (France), Cambridge (Massachusetts, United States), October 2, 2019,
8:00am CEST - Biophytis SA (Euronext Growth Paris: ALBPS), a clinical-stage
biotechnology company focused on the development of drug candidates for the
treatment of age-related diseases with a primary focus on neuromuscular
diseases, today announces that it will present two posters highlighting
preclinical data on Sarconeos (BIO101) and two posters highlighting the
innovative MYODA clinical trial design of a pediatric formulation of Sarconeos
(BIO101) for Duchenne muscular dystrophy (DMD) at the 24th International Annual
Congress of the World Muscle Society (WMS) to be held in Copenhagen, Denmark,
October 1-5th, 2019.

Biophyits' lead drug candidate Sarconeos (BIO101) is an orally administered
small molecule currently being tested in the Phase 2b SARA-INT study in
patients with sarcopenia. An oral pediatric formulation is being developed to
address development challenges for patients with DMD.

Stanislas Veillet, Ph.D., chief executive officer of Biophytis said "We are
pleased to have the opportunity to present our preclinical data on Sarconeos
(BIO101) and provide updates around the innovative MYODA clinical trial design
at the World Muscle Society congress. These preclinical data further emphasize
the potential of Sarconeos (BIO101) as a treatment for neuromuscular diseases,
in particular DMD and SMA. We will also present updates outlining the merits of
the planned seamless trial design from Phase I to III and a composite score
that we aim to use to measure the efficacy of Sarconeos (BIO101) in our
upcoming MYODA clinical program in ambulatory and non-ambulatory patients with
DMD."

Mr Veillet added "We are currently preparing to submit an investigational new
drug (IND) application to the US Food and Drug Administration (FDA) and
clinical trial applications to the competent National and/or European
regulatory agencies, to gain the approvals for our oral pediatric formulation
of Sarconeos (BIO101) in order to be ready to commence the MYODA clinical
program in 2020."

Poster Presentations

Title:     BIO101 demonstrates combined beneficial effects on skeletal muscle
           and respiratory functions in a mouse model of Duchenne muscular
           dystrophy

Authors:   Pierre Dilda, Mathilde Latil, Blaise Didry-Barca, Sissi On,
           Maria Serova, Kamel Mamchaoui, Stanislas Veillet, René Lafont.

Session.:  Poster Session: DMD animal model. Poster Number: P311

Date/Time: Friday, October 4, 2019 3:00 to 4:15 PM

Title:     The MYODA operational seamless clinical trial design phase I to
           III. A new approach for rare diseases to evaluate the safety,
           efficacy Pharmacokinetics, and Pharmacodynamics of BIO101
           (MAS activator) in paediatric patients with a genitically confirmed
           diagnosis of Duchenne muscular dystrophy (DMD)

Authors:   Mounia Chabane, Waly Dioh, Pierre Dilda , René Lafont ,
           Stanislas Veillet, Thomas Voit, Samuel Agus

Session.:  Poster Session: DMD clinical and biomarkers. Poster Number: P.149
           Date/Time:  Wednesday, October 2, 2019 4:45 to 6:15 PM

Title:     MYODA clinical program: Composite score for assessing the efficacy
           of BIO101 (MAS activator) in ambulatory and non-ambulatory
           Duchenne boys

Authors:   Mounia Chabane, Waly Dioh, Pierre Dilda, René Lafont,
           Stanislas Veillet, Thomas Voit, Samuel Agus

Session.:  Poster Session: DMD outcome measures. Poster Number EP.87
           screen L2

Date/Time: Friday, October 4, 2019 3:00 PM

Title:     BIO101 demonstrates combined beneficial effects on muscle and
           motor neurons in a mouse model of severe spinal muscular atrophy

Authors:   Mathilde Latil, Cynthia Bézier, Steve Cottin, René Lafont,
           Stanislas Veillet, Pierre Dilda, Frédéric Charbonnier, Olivier
           Biondi

Session.:  Poster Session: SMA treatments. Poster Number: P370

Date/Time: Friday, October 4, 2019 4:15 to 5:30 PM

About the MYODA program

Biophytis is preparing to advance an oral pediatric formulation of Sarconeos
(BIO101) for Duchenne muscular dystrophy (DMD) into the clinic through its
MYODA program, subject to regulatory approval.

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. It proposes to incorporate two innovative
clinical features; (i) a seamless trial design that allows patients to
participate across multiple phases, and (ii) multiple clinical endpoints
(Composite Score) that combine muscle strength, mobility and respiratory
function and are adapted to the stage of severity of the disease in each
patient.

About Biophytis

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 US and
Europe. A pediatric formulation of Sarconeos (BIO101) is being developed for
the treatment of Duchenne muscular dystrophy (DMD). Biophytis expects Sarconeos
(BIO101) to be ready to enter the clinic for DMD in 2020, subject to regulatory
approval. 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 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
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
Quentin Dussart / Sylvie Berrebi / Nathaniel Dahan / David Dible
biophytis@citigatedewerogerson.com
Tel: +33 (0)1 55 30 70 91 / +44 (0)20 76389571

Source: Biophytis

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BIOPHYTIS (EPA:ALBPS) - Biophytis to Present Four Posters at the 24th Annual Congress of the World Muscle Society (WMS) in Copenhagen, Denmark

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