BIOPHYTIS (EPA:ALBPS) - Biophytis Opens 22nd Clinical Site in the SARA-INT Phase 2b Trial of Sarconeos (BIO101) for the Treatment of Sarcopenia

Transparency directive : regulatory news

04/10/2019 08:00

Press release

Biophytis Opens 22nd Clinical Site in the SARA-INT Phase 2b Trial of Sarconeos
                  (BIO101) for the Treatment of Sarcopenia

  Target number of clinical sites reached, including leading hospitals and
                   geriatric centers in the US and Europe

             Patient enrollment expected to complete in mid-2020

Paris (France), Cambridge (Massachusetts, United States), October 4, 2019,
08:00 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, announced today that the 22nd clinical site has been opened in the US
for the SARA-INT clinical trial, a Phase 2b clinical trial evaluating the
safety and efficacy of Biophytis' lead drug candidate, Sarconeos (BIO101), for
the treatment of sarcopenia.

Roger Fielding, PhD, Director of the Nutrition, Exercise Physiology &
Sarcopenia Laboratory at Tufts University in Boston and Principal Investigator
of SARA-INT trial commented, "The SARA-INT Phase 2 trial is investigating a new
treatment for sarcopenia, a disease of aging which is characterized by loss of
muscle mass and function. Following the supportive preliminary data, this trial
will evaluate the efficacy of BIO101 on muscle function and mobility in older
adults."

The SARA-INT study is a multicenter double-blind, placebo-controlled,
randomized interventional Phase 2b clinical trial evaluating Sarconeos (BIO101)
in patients with sarcopenia at risk of mobility disability in the US and
Europe. The primary objective of the Phase 2b trial is to evaluate the safety
and efficacy of Sarconeos (BIO101) administered orally in two doses (175 mg bid
and 350 mg bid) in patients with sarcopenia at risk of mobility disability.
Sarcopenia is an age-related degeneration of skeletal muscle, which is
characterized by a loss of muscle mass, strength and function in elderly people
over the age of 65 leading to mobility disability and increased risk of adverse
health events and hospitalization, and potential death.

The SARA-INT trial protocol, including the main study endpoints, was defined
following a scientific opinion from the European Medicines Agency (EMA) and
input from the Food & Drug Administration (FDA). The primary endpoint is the
gait-speed over the 400-meter walk test (400MWT), which represents a measure of
the participant's mobility function. Biophytis is still waiting for an
authorization from the French drug agency, ANSM, to begin the study in France,
which may lead to additional clinical sites being opened.

Biophytis' lead drug candidate, Sarconeos (BIO101), is an orally administered
small molecule in development for the treatment of neuromuscular diseases.
Preclinical data demonstrated that Sarconeos (BIO101) for the treatment of
sarcopenia has beneficial effects on muscle function and increases muscle
strength and mobility in animal models.

Sarconeos (BIO101) is thought to activate the MAS receptor in muscle cells, a
key component of the renin- angiotensin system (RAS). The RAS is a fundamental
endocrine system that is known to control fluid balance, blood pressure and
cardio-vascular function. Importantly, the RAS is also involved in the
regulation of smooth, cardiac and skeletal muscle metabolism and plays a key
role in muscle function and mobility.

"Reaching the targeted number of clinical centers in the SARA-INT trial is a
significant milestone as we advance our lead drug candidate Sarconeos
(BIO101)," said Stanislas Veillet, CEO of Biophytis. "We believe sarcopenia
remains a unmet medical need due to the disability, cost and mortality it
causes, and the fact that there are currently no approved medications to
prevent or slowdown the disease. The SARA-INT trial is an important study as it
is recruiting patients with severe sarcopenia who experience a clinically
meaningful decrease in their mobility over a six-month period. We remain
focused on activities to drive patient recruitment so that we can complete
enrollment of the SARA-INT trial as expected in mid-2020."

Sarconeos (BIO101) is also being developed for the treatment of Duchene
muscular dystrophy (DMD), a severe type of muscular dystrophy. Biophytis
expects Sarconeos (BIO101) to be ready to enter the clinic for DMD in 2020,
subject to regulatory approval.

About Sarcopenia
Sarcopenia is an age-related degeneration of skeletal muscle, which is
characterized by a loss of muscle mass, strength, function and mobility
disability, and increased risk of adverse health events and potential death
resulting from falls, fractures, and physical disability. There are currently
no approved drug treatments for sarcopenia, which has become the focus of
increased research aiming to improve diagnosis and treatment. Sarcopenia is
highly prevalent in the elderly with an estimated prevalence between six and 22
percent.

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 Opens 22nd Clinical Site in the SARA-INT Phase 2b Trial of Sarconeos (BIO101) for the Treatment of Sarcopenia

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