BIOPHYTIS (EPA:ALBPS) - Biophytis SARA-INT Phase 2b study, evaluating the efficacy of Sarconeos (BIO101) in sarcopenia, has now achieved over 50% patient recruitment

Transparency directive : regulatory news

27/01/2020 08:00

Press Release

    Biophytis SARA-INT Phase 2b study, evaluating the efficacy of Sarconeos
     (BIO101) in sarcopenia, has now achieved over 50% patient recruitment

Paris (France), Cambridge (Massachusetts, United States), January 27, 2020, 8
a.m. CET - Biophytis SA (Euronext Growth Paris: ALBPS), a clinical-stage
biotechnology company with a primary focus on the development of its lead drug
candidate Sarconeos (BIO101), for the treatment of neuromuscular diseases,
today announces that it has recruited over 50% of the patients needed to
complete the SARA-INT Phase2b clinical trial. At present, more than 50 patients
have received 6 months of treatment. Based on an independent Data Safety
Monitoring Board (DSMB) review (conducted every quarter, 4 times so far),
to-date, there are no signals to warrant concerns on safety or tolerability of
Sarconeos (BIO101).

The SARA-INT study is a multicenter double-blind, placebo-controlled,
randomized interventional Phase 2b clinical trial evaluating 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. The
primary endpoint is the gait- speed over the 400-meter walk test (400MWT),
which represents a measure of the participant's mobility function. The study
anticipates recruiting a total of 334 patients.(1)

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 (over 65) with an estimated prevalence between
6 and 22 percent.

Samuel Agus, Chief Medical Officer, declares: "We are encouraged that we are
now recruiting rapidly into the SARA-INT study. Our inclusion criteria, based
on the initial findings from the SARA-OBS study, are designed to select a
population, which is at higher risk of mobility disability. It has been a
challenge to find these patients but having implemented a number of initiatives
to speed up recruitment we are experiencing a significant ramp- up. We are
confident of completing patient recruitment into the SARA-INT study as planned.
We are also encouraged by the fact that the benefit:risk profile of Sarconeos
(BIO101), continues to be considered by the DSMB as favorable."

Stanislas Veillet, Chief Executive Officer, says: "I am pleased that we have
reached this important milestone in the SARA-INT study. With a total of 172
patients recruited in 22 clinical sites in the U.S. and in Belgium, we are
confident that Biophytis can achieve this clinical trial on time and generate
significant value."

                                      ****

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.

(1) A protocol amendment that includes a reduction of the sample size needed
for the study has been submitted to the FDA and is pending approval, re
Biophytis press release dated October 31st, 2019

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), for which the company was granted FDA IND approval in December 2019.

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 Contact
Evelyne Nguyen, CFO
contact@biophytis.com

Media Contact
Citigate Dewe Rogerson
Sylvie Berrebi / David Dible / Nathaniel Dahan / Quentin Dussart
biophytis@citigatedewerogerson.com
Tel: +33 (0)1 55 30 70 91 / +44 (0)20 76389571

Source: Biophytis

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