BIOPHYTIS (EPA:ALBPS) - Biophytis Files Protocol Amendment to Optimize the SARA-INT Phase 2b Clinical Trial for Sarcopenia

Transparency directive : regulatory news

31/10/2019 08:00

Press Release

Biophytis Files Protocol Amendment to Optimize the SARA-INT Phase 2b Clinical
                             Trial for Sarcopenia

* The amendment, which was filed with the FDA and AFMPS, proposes a reduction
  in the number of patients needed in SARA-INT based on fast deterioration of
  mobility seen in the SARA-OBS study in participants with sarcopenia
* Interim analysis planned to assess the likelihood of success of the SARA-INT
  study based on the revised participant population size

Paris (France), Cambridge (Massachusetts, U.S.), October 31, 2019, 08:00 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, announces the
filing of an amendment to the SARA-INT Phase 2b clinical trial protocol with
the U.S. Food and Drug Administration (FDA) and the Belgian regulatory agency,
L'Agence fédérale des médicaments et des produits de santé (AFMPS).

The amendment proposes a reduction in the target number participants that will
need to be recruited into the SARA-INT study. This planned change is based on
preliminary analysis of the SARA-OBS study population, presented at the
European Geriatric Medicine (EuGMS) congress in September 2019, which showed a
rapid deterioration of the mobility in the participants as measured by the
400-meter walk test (400MWT). The protocol amendment is subject to review and
approval by the appropriate regulatory agencies (FDA and AFMPS).

Biophytis is using the same selection criteria for both the SARA-OBS study and
the ongoing SARA-INT Phase 2b clinical trial evaluating the safety and efficacy
of BIO101, for the treatment of patients with sarcopenia at risk of mobility
disability. These criteria are more stringent than those utilized in previous
sarcopenia studies.

The amendment also includes a plan for an unblinded interim analysis to
reconfirm the deterioration of mobility over 6 months and to assess the
likelihood of success of the SARA-INT study based on the revised patient
population size.

In addition, the company provided the regulatory agencies with a routine update
on Sarconeos (BIO101).

Sam Agus, Chief Medical Officer of Biophytis, said, "Our analysis of the
preliminary data from the SARA- OBS observational study has shown that we are
recruiting the right patient population into the SARA-INT Phase 2b clinical
trial, namely patients with severe sarcopenia that are at a high risk for
mobility disability. We believe these patients have a significant unmet medical
need as they are less likely to respond to exercise alone and are in need of a
medication for the treatment of their disease. The results also show these
patients experience a more rapid functional deterioration in mobility than
originally expected, particularly in the 400-meter walk test, which is the
primary endpoint in the SARA-INT clinical trial. Based on these findings we now
expect the SARA-INT to show that BIO101 delivers a larger treatment effect
versus placebo than we previously anticipated. Therefore, we have used these
findings to file protocol amendments with the appropriate regulatory agencies,
which, if approved, could allow us to make positive changes to the SARA- INT
study design."

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.

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
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),
which Biophytis expects to be ready to enter the clinic for 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
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

Europe 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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