BIOPHYTIS (EPA:ALBPS) - Biophytis Enrolls First Patient in Brazil 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

26/10/2020 07:00

Press release

Biophytis Enrolls First Patient in Brazil 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 at Hospital e Maternidade Celso Pierro -
                             PUCCAMP in Campinas

    Ten centers now open for patient recruitment in Europe and the Americas

Paris, (France), Cambridge (Massachusetts, United States), October 26, 2020,
8:00 a.m. CET - 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 in Brazil has been dosed at Hospital e
Maternidade Celso Pierro - PUCCAMP in Campinas 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 is progressing at
pace with ten centres now open to recruit patients in Belgium, France, Brazil
and in the US.

Ludhmila Abrahão Hajjar, MD, PhD, Professor at the Faculty of Medicine
University of São Paulo, (InCor HCFMUSP, São Paulo, Brazil) and Principal
Investigator of COVA in Brazil, said: "There is currently an urgent need for
improved treatment options to help COVID-19 patients, and particularly those in
vulnerable categories who are most at risk of suffering severe respiratory
complications. Having dosed the first patient with BIO101 here in Brazil, we
are hoping that our clinical research will help find an urgently needed
treatment option that could improve the care of vulnerable COVID-19 patients
globally."

The COVA clinical program (clinicaltrials.gov identifier NCT04472728) is a
Phase 2/3, randomized, double-blind, placebo-controlled, adaptive and group
sequential study assessing Sarconeos (BIO101) in patients aged 45 and older,
infected with SARS-CoV-2. It is designed to evaluate the efficacy and the
safety of Sarconeos (BIO101) as a treatment to prevent further deterioration in
patients with COVID-19-related respiratory failure. The objective is to prevent
them from being admitted to the intensive care unit (ICU) and requiring
ventilation.

This pivotal multinational clinical trial is being conducted in two parts, the
first of which will assess the 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 primary endpoint of the COVA study 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.

Stanislas Veillet, CEO of Biophytis says: "We are delighted to have started
dosing the first patient in Brazil, a country particularly hard-hit by the
pandemic. Biophytis is one of the few European biotechs with access to a strong
network of clinic sites in the Americas, especially Latin America where we have
recently reactivated our Brazilian branch. This milestone highlights the
excellent progress we are making in evaluating BIO101 as a potentially improved
and differentiated treatment option for patients with COVID-19 related severe
respiratory manifestations globally."

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 patients with
COVID-19 related respiratory failure in a Phase 2/3 clinical study (COVA) in
the United States, Europe and Latin America.

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 Brazil 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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