BIOPHYTIS (EPA:ALBPS) - Biophytis Receives Approval from the Belgian Regulatory Agency (FAMHP) to Initiate COVA, a Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID19 Related Respiratory Failure

Transparency directive : regulatory news

20/05/2020 08:02

Press release

  Biophytis Receives Approval from the Belgian Regulatory Agency (FAMHP) to
Initiate COVA, a Clinical Trial with Sarconeos (BIO101) for the Treatment of
            Patients with COVID- 19 Related Respiratory Failure

This Phase 2/3 clinical trial is expected to start in Belgium in the coming
                                    weeks

Paris, (France), Cambridge (Massachusetts, United States), May 20, 2020, 8:00
a.m. CEST - Biophytis SA (Euronext Growth Paris: ALBPS), a clinical-stage
biotechnology company specialized in the development of drug candidates for
treatment of aged related diseases, amongst which neuromuscular diseases, today
announces that it has received approval from the Belgian regulatory agency, the
Federal Agency for Medicines and Health Products (FAMHP), to proceed with its
clinical development program COVA. This 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 the safety
of Sarconeos (BIO101) as a treatment to prevent further respiratory
deterioration in COVID-19 patients with severe respiratory failure. A Phase
2/3, randomized, double-blind, placebo-controlled, adaptive and group
sequential study assessing Sarconeos (BIO101) in patients infected with
SARS-CoV-2 is expected to start in the coming weeks in Belgium.

Coordinated by Dr Muriel Lins, Pulmonologist at AZ Sint Maarten hospital in
Mechelen and Principal Investigator of COVA in Belgium, this potential pivotal
clinical trial will be a two-part study.

The first part of the study will recruit COVID-19 patients who have developed
severe respiratory symptoms within the last 7 days. This first part will
include 50 COVID-19 patients with the main criteria being the absence of
patients with, high-flow oxygen use, assisted ventilation, or death, within a
28-day period. Multiple secondary criteria, including Sarconeos (BIO101)'s
safety and tolerability, improvements in COVID-19 patients' respiratory
function, and effects on biomarkers associated with the Renin-Angiotensin
System (RAS), target of Sarconeos (BIO101) will also be evaluated.

An interim analysis conducted by an independent Data Monitoring Committee
(DMC), expected in the 4th quarter of this year, subject to the evolution of
the COVID-19 epidemic, will determine whether the study should progress into
the second part and will allow recruitment of required sample size needed for
detecting Sarconeos (BIO101) effects in part 2.

The interim analysis will also provide preliminary data on the efficacy of
Sarconeos (BIO101) to prevent the deterioration of respiratory function in
COVID-19 patients.

The second part of the COVA trial which will include at least 180 COVID-19
patients will also last 28 days and evaluate the same main and secondary
criteria as those measured in the first part.

Stanislas Veillet, President and CEO of Biophytis, said: "We are very pleased
to have received approval from the FAMHP to start our COVA clinical program. We
expect to start this important program in the coming weeks in Belgium as we
look to extend to multiple sites in Europe and US pending potential approvals
from the ANSM, MHRA and FDA. The first part of the COVA study will provide us
with important preliminary data as we work to confirm that Sarconeos (BIO101)
can successfully prevent the deterioration of the respiratory function in
Covid-19 patients. Based on its mode of action we are confident that Sarconeos
(BIO101) could become an important - potentially life-saving - treatment for
patients with acute respiratory failure associated with COVID-19. "

The Company has also worked with its suppliers to ensure that it has access to
sufficient Sarconeos (BIO101) to complete the multi-center COVA trial program
as planned.

The Coronavirus SARS-CoV-2 can cause Acute Respiratory Distress Syndrome (ARDS)
by disrupting the renin angiotensin system (RAS), which has a key role in
regulating respiratory function. It is believed that SARS-CoV-2 enters the lung
cells using the Angiotensin 2 Converting Enzyme (ACE-2), a key enzyme in the
RAS, inhibiting the system's protective arm.

Sarconeos (BIO101) activates the MAS receptor, a key component of the
protective arm of the RAS, and has been shown to restore respiratory function
in several preclinical models.

Sarconeos (BIO101) has demonstrated a good safety profile during the SARA
development program, which is evaluating its ability to improve muscle function
in frail elderly patients with sarcopenia. Sarconeos (BIO101) is also being
developed to improve the respiratory function of children with Duchenne
muscular dystrophy (DMD).

The COVA program builds on the clinical and preclinical data generated with
Sarconeos (BIO101) in these neuromuscular diseases.

                                   ***

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, especially
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) will also be developed as a treatment for Covid-19
(Coronavirus). The Company has received approval from the Belgian Regulatory
Authority (FAMHP) to begin the Phase 2/3 clinical trial (COVA) with Sarconeos
(BIO101), evaluating it as a potential treatment for respiratory failure
associated with Covid-19. The Company also filed clinical trial applications
with the FDA in the US, MHRA in the UK and 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 Approval from the Belgian Regulatory Agency (FAMHP) to Initiate COVA, a Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID19 Related Respiratory Failure

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