Biophytis Receives Approval from the Belgian Regulatory Agency to Proceed with
the MYODA Program for Clinical Development of Sarconeos (BIO101) in Patients
MYODA clinical protocol adjusted with Respiratory Function now being the
Paris (France), Cambridge (Massachusetts, U.S.), March 30, 2020, 8:00 a.m. CET
- Biophytis SA (Euronext Growth Paris: ALBPS), a clinical-stage biotechnology
company with a primary focus on the treatment of neuromuscular diseases, today
announces that it received approval from the Belgian regulatory agency, Federal
Agency for Medicines and Health Products (FAMHP), to proceed with its clinical
investigation of Sarconeos (BIO101) in non-ambulatory patients with Duchenne
Muscular Dystrophy (DMD). This follows the FAMHP completion of the safety
review of the clinical trial application filed by Biophytis earlier this
Biophytis' planned MYODA clinical program is based on a 3-part, randomized,
double blind, adaptive seamless Phase 1 to 3 clinical study, to evaluate the
safety and efficacy of a pediatric formulation of Sarconeos (BIO101) in
non-ambulatory patients with DMD and evidence of respiratory deterioration.
FAMHP also cleared a protocol adjustment that changed respiratory function to
the primary endpoint. This protocol has also been discussed with the US Food
and Drug Administration (FDA). The MYODA program was previously going to use a
composite score to evaluate the functional benefits that Sarconeos (BIO101) can
deliver in this indication.
Stanislas Veillet, Chief Executive Officer, stated: "We are very pleased to
have received approval to proceed with the MYODA clinical program in Belgium.
Following encouraging preclinical data, we believe Sarconeos (BIO101) has the
potential to be a much-needed treatment for DMD patients, a devastating disease
with limited treatment options currently available. Our MYODA clinical program
incorporates a seamless trial design that aims to clearly demonstrate the
functional, and specifically respiratory benefits that Sarconeos (BIO101) could
deliver to this severe and underserved patient population.
Due to Covid-19, the FDA updated its guidance for conducting clinical trials.
As of today, we are still planning on initiating the MYOADA clinical program in
H2 2020. We intend to update the market if the timeline changes."
The investigational plan includes a separate clinical trial to evaluate the
safety and efficacy of Sarconeos (BIO101) in ambulatory DMD patients at a later
The development of Sarconeos (BIO101) in DMD has received strong interest from
patient associations, among which AFM Téléthon in France. In June 2019
Biophytis and AFM Téléthon entered a collaboration agreement for the
development of Sarconeos (BIO101) in this indication.
Biophytis SA is a clinically staged biotechnology company specializing in the
development of drug candidates to slow down degenerative processes and improve
functional abilities in patients with age- related diseases, particularly
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 BIO101 is being
developed for the treatment of Duchenne myopathy (DMD). The company intends to
start MYODA clinical program in H2 2020.
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 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 2018
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