BIOPHYTIS (EPA:ALBPS) - Biophytis Receives FDA IND Clearance for COVA, a Phase 2/3 Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure

Transparency directive : regulatory news

01/07/2020 21:05

Press release

Biophytis Receives FDA IND Clearance for COVA, a Phase 2/3 Clinical Trial with
Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related
Respiratory Failure

Paris, (France), Cambridge (Massachusetts, United States), July 1, 2020, 9:00
pm CEST - Biophytis SA (Euronext Growth Paris: ALBPS), a clinical-stage
biotechnology company specialized in the development of drug candidates for the
treatment of aged related diseases, including neuromuscular diseases, today
announces that the United States (US) Food and Drug Administration (FDA) has
accepted the Investigational New Drug (IND) application to proceed with its
clinical development program COVA. This Phase 2/3 program will assess Sarconeos
(BIO101) as a potential treatment for acute respiratory failure associated with
COVID-19.

The COVA clinical program is designed to evaluate the efficacy and safety of
Sarconeos (BIO101) as a treatment of the respiratory deterioration in COVID-19
patients with severe respiratory failure. This pivotal, international clinical
trial will be conducted in two parts, the first of which has the objective to
assess treatment safety and provide an indication of activity of Sarconeos
(BIO101), in 50 hospitalized COVID-19 patients suffering from acute respiratory
deficiency. The second part of the study will investigate the efficacy of
Sarconeos (BIO101) on the respiratory function of around 300 additional
patients.

Stanislas Veillet, CEO of Biophytis, said: "There is an urgent need for
therapies to help patients with COVID-19 Acute Respiratory Distress Syndrome
(ARDS) given the continuing rapid spread of SARS-CoV-2 and limited therapeutic
options. With FDA clearance, we intend to initiate a clinical trial to evaluate
Sarconeos (BIO101) in patients with acute respiratory failure associated with
COVID-19. The elderly and those with comorbidities are at highest risk of death
from SARS- CoV-2. We have already initiated the work to start this key Phase
2/3 trial as soon as possible in the US, and in the European countries where we
received approval, and will update the market shortly on our planned
timelines."

About BIOPHYTIS
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
neuromuscular diseases.

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 FAMHP (Belgium), the MHRA (UK) and US FDA 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 also filed a clinical trial application with the French regulatory
agency, ANSM in France.

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

Disclaimer

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
evelyne.nguyen@biophytis.com

Media contact
Citigate Dewe Rogerson
Sylvie Berrebi/ Nathaniel Dahan/ David Dible / Quentin Dussart
biophytis@citigatedewerogerson.com
Tel: +44 (0) 20 7638 9571 / +33 (0)1 55 30 70 91

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BIOPHYTIS (EPA:ALBPS) - Biophytis Receives FDA IND Clearance for COVA, a Phase 2/3 Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure

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