Biophytis provides an update on SARA-INT, a Phase 2b clinical trial evaluating
the efficacy of Sarconeos (BIO101) in the treatment of sarcopenia
Re opening of investigation sites in Belgium and in the US
Treatment period extended by 3 months based on a review of the DSMB and the
favorable risk profile of Sarconeos (BIO101)
Paris (France), Cambridge (Massachusetts, United States), August 28, 2020,
7 p.m. CEST - Biophytis SA (Euronext Growth Paris: ALBPS), a clinical-stage
biotechnology company specialized in the development of drug candidates for
treatment of age-related diseases, including neuromuscular diseases, today
provides an update on the SARA-INT clinical development program, a Phase 2b
study evaluating the efficacy of Sarconeos (BIO101) in sarcopenia.
The last of the 231 patients to be included in the SARA-INT trial study was
recruited in March 2020. Due to COVID-19, Biophytis had to adapt the SARA-INT
protocol in order to ensure the continuity of the trial, in particular by:
* closing all on-site activities and
* organizing patient follow-up to take place at home.
These changes were based on recommendations from both the US Food and Drug
Administration (FDA) guidance and the Data and Safety Monitoring Board (DSMB)
designed to preserve patients' safety in ongoing clinical trials.
The Company announces today the re-opening of four of its sites in Belgium and
the US. Other sites should re- open progressively depending on the local
evolution of the pandemic. For sites that are not re-opening, treatment will be
extended by 3 months based on a review of the DSMB and the favorable risk
profile of Sarconeos (BIO101).
As a result of these protocol changes, and depending on the evolution of the
pandemic, the last patient out from the SARA-INT study is now expected at the
end of 2020.
The SARA-INT study elderly population is particularly vulnerable to the
consequences of the COVID-19 pandemic. As a result, the final number of
patients to be analyzed in the study will be reduced significantly. Despite
this, the study is expected to provide sufficient data to give a clear view of
the potential benefits of Sarconeos (BIO101). To date, 64 patients are already
qualified as "completers" and accounted for in the final analysis.
As a result of the delays incurred due to the COVID-19 pandemic, and provided
top line results to come, no interim analysis will be undertaken by the DSMB.
Stanislas Veillet, Chief Executive Officer, says: "We are very pleased that
some sites have now re-opened and that the FDA and AFMPS in Belgium, and the
DSMB approved the extension of the treatment period in the SARA- INT Phase 2
study by three months based on Sarconeos (BIO101) favorable risk profile. The
team at Biophytis continues to be very active in ensuring the best follow-up of
patients enrolled into the study despite the COVID- 19 crisis. Following recent
measures to ease the confinement rules in the US and in Belgium Biophytis has
updated its guidance for conducting follow-up visits and this has been
reflected in the study's protocol. We are confident to have our last patient
out by the end of this year in order to announce top line results by H1 2021."
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
6 and 22 percent.
Biophytis SA is a clinical-stage biotechnology company specialized in the
development of drug candidates to slow down degenerative processes and improve
functional abilities in patients with age- related diseases, including
Sarconeos (BIO101), our leading drug candidate, is a small molecule,
administered orally, currently in clinical Phase 2b in sarcopenia (SARA-INT) in
the United States and Europe. A pediatric formulation of Sarconeos (BIO101) is
being developed for the treatment of Duchenne Muscular Dystrophy (DMD). The
company plans to start the clinical development (MYODA) in H2 2020.
Sarconeos (BIO101) is also being developed as a treatment for COVID-19. The
Company has received approval from ANSM (France), FAMHP (Belgium), ANVISA
(Brazil), the MHRA (UK) and the FDA in the US to begin the Phase 2/3 clinical
trial (COVA) to evaluate Sarconeos (BIO101) as a potential treatment for
respiratory failure associated with COVID-19.
The company is based in Paris, France, and Cambridge, Massachusetts. The
company's common shares are listed on the Euronext Growth Paris market (Ticker:
ALBPS - ISIN: FR0012816825). For more information visit www.biophytis.com
This press release contains forward-looking statements. While the Company
considers its projections to be based on reasonable assumptions, these
forward-looking statements may be called into question by a number of hazards
and uncertainties, so that actual results may differ materially from those
anticipated in such forward-looking statements. For a description of the risks
and uncertainties likely to affect the results, BIOPHYTIS' financial position,
performance or achievements and thus cause a change from the forward-looking
statements, please refer to the "Risk Factors" section of the Company's 2019
Annual Report available on BIOPHYTIS website (www.biophytis.com).
This press release, and the information contained in it, does not constitute an
offer to sell or subscribe, nor the solicitation of a purchase or subscription
order, of BIOPHYTIS shares in any country. The elements contained in this
communication may contain forward-looking information involving risks and
uncertainties. The Company's actual achievements may differ materially from
those anticipated in this information due to different risk and uncertainty
factors. This press release was written in French and English; If there is a
difference between the texts, the French version will prevail.
Biophytis Contact for Investor Relations
Evelyne Nguyen, CFO