BIOPHYTIS (EPA:ALBPS) - Biophytis Enrolls First Patient in COVA, a Multinational Phase 2/3 Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure

Transparency directive : regulatory news

01/09/2020 08:00

Press release

  Biophytis Enrolls First Patient in COVA, a Multinational Phase 2/3 Clinical
   Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19
                          Related Respiratory Failure

                   First Patient Dosed in Mechelen, Belgium

   5 centers in Belgium, France and the US are open for patient recruitment

Paris, (France), Cambridge (Massachusetts, United States), September 1, 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 age-related diseases, including neuromuscular diseases, today
announces that the first patient has been dosed at AZ Sint Maarten hospital in
Mechelen, Belgium in COVA, a Phase 2/3 Clinical Trial with Sarconeos (BIO101)
for the treatment of patients with COVID-19-related respiratory failure. The
multinational trial has been making good progress and now has five centers
ready for patients recruitment in Belgium, France and the US.

Dr Muriel Lins, Pulmonologist at AZ Sint Maarten hospital in Mechelen and
Principal Investigator Coordinator of COVA in Belgium, said: "COVID-19 can have
devastating effects on patients, particularly those in vulnerable categories,
who are at risk of developing severe respiratory complications, and there is
much need for more treatment options to address those. We are pleased to be the
first site to treat patients with BIO101. It reflects on our commitment to
advancing clinical research on COVID-19 to provide patients with severe
respiratory manifestations the best care and improve their chances of
survival."

The COVA clinical program is a Phase 2/3, randomized, double-blind,
placebo-controlled, adaptive and group sequential study assessing Sarconeos
(BIO101) in patients infected with SARS-CoV-2. It 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.

This pivotal clinical trial (NCT04472728) taking place in Belgium, France,
Brazil, the UK and US, 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 an additional 260 COVID-19 patients.
The trial expects to recruit a total of about 310 patients.

The primary endpoint is the proportion of all-cause mortality and respiratory
deterioration within up to a 28-day period.

Secondary endpoints include records of improvement, worsening and hospital
discharge, functional scales and the biomarkers associated with the mechanism
of action of Sarconeos (BIO101) and inflammation.

"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 cells
in various tissues using the Angiotensin 2 Converting Enzyme (ACE-2), a key
enzyme in the RAS, thus inhibiting the system's protective arm. Sarconeos
(BIO101) activates the MAS receptor, a key component of the protective arm of
the RAS," added Dr Sam Agus, Chief Medical Officer of Biophytis. "We believe
that a drug with Sarconeos (BIO101)'s mode of action could provide an important
treatment option for COVID- 19 patients with severe respiratory failure."

Stanislas Veillet, CEO of Biophytis says: " Whilst in many countries COVID-19
has continued its steady spread, in Europe we are seeing again a worrying
increase of new COVID-19 cases. With physicians still in need of effective
treatments for COVID-19-related respiratory failure, we believe Sarconeos
(BIO101) has the potential to serve as a differentiated treatment option for
patients with severe respiratory manifestations. Our teams, together with SGS,
a global CRO we selected, have been very active in implementing the protocol's
requirements. The first patient dosed is an important milestone for the
multinational COVA study which is now recruiting at five centers in France,
Belgium and the US."

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 initiated the COVA trial in Belgium and also received approval from
ANSM (France), ANVISA (Brazil), 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 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 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
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 Enrolls First Patient in COVA, a Multinational Phase 2/3 Clinical Trial with Sarconeos (BIO101) for the Treatment of Patients with COVID-19 Related Respiratory Failure

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