BIOPHYTIS (EPA:ALBPS) - Biophytis - First Patient Enrolled in France in COVA, an International Phase 2/3 Clinical Trial with Sarconeos (BIO101) for the Treatment of COVID-19 Related Respiratory Failure

Transparency directive : regulatory news

11/12/2020 08:00

Press release

Biophytis - First Patient Enrolled in France in COVA, an International Phase
   2/3 Clinical Trial with Sarconeos (BIO101) for the Treatment of COVID-19
                         Related Respiratory Failure

   First Patient Dosed at La Pitié-Salpêtrière University Hospital in Paris

Total of eight centers authorized by French National Health Agency (ANSM) for
                        patient recruitment in France

Paris, (France), Cambridge (Massachusetts, United States), December 11, 2020,
8:00 a.m. CET - Biophytis SA (Euronext Growth Paris: ALBPS), a clinical-stage
biotechnology company focused on the development of therapeutics that slow the
degenerative processes associated with aging and improve functional outcomes
for patients suffering from age-related diseases, including severe respiratory
failure in patients suffering from COVID-19, today announces that the first
French patient has been dosed at La Pitié-Salpêtrière University Hospital,
Paris, in COVA. The COVA study is a Phase 2/3 clinical trial with Sarconeos
(BIO101) for the treatment of patients with COVID-19-related respiratory
failure. Dr. Capucine Morelot-Panzini, Professor of Pulmonology at the
Pitié-Salpêtrière University Hospital in Paris is the Principal Investigator
of COVA in France.

In addition to the two first centers at the Pitié-Salpêtrière University
Hospital in Paris, Biophytis also received approval from the French National
Agency for Medicines and Health Products Safety (ANSM) this month to open six
new centers in France, among which Centre Hospitalier Rene Dubos and Centre
Hospitalier d'Argenteuil in the Paris Region, bringing the total to eight
centers planned to recruit COVID-19 patients in France.

A total of 17 centers are now actively recruiting in Belgium, Brazil, France
and the US among a targeted number of around thirty to be opened for the second
part of the COVA study .

The international COVA clinical program (clinicaltrials.gov identifier
NCT04472728) is a global, multicentric, double-blind, placebo-controlled,
group-sequential and adaptive two-part Phase 2-3 study assessing Sarconeos
(BIO101) in patients aged 45 and older, infected with SARS-CoV- 2.

This pivotal 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 patients. The study is designed to
evaluate the efficacy and the safety of Sarconeos (BIO101) as a treatment to
prevent further deterioration of patients with COVID-19-related respiratory
failure, which could otherwise require admission to the intensive care units
and ventilation.

The first part of the study is a Phase 2 exploratory proof of concept study to
provide preliminary data on the activity, safety and tolerability of Sarconeos
(BIO101) in 50 hospitalized patients with severe respiratory manifestations
related to COVID-19.

The second part of the study will investigate the safety and efficacy of
Sarconeos (BIO101) on the respiratory function of 310 COVID-19 patients
(including the 50 patients from Part 1 of the study).

Interim analysis and completion of full trial enrollment is expected in Q1
2021.

Stanislas Veillet, CEO of Biophytis says: "I am very pleased that after all of
the efforts by our teams over the past few months, we can now announce the
first patient has been dosed at La Pitié-Salpêtrière Hospital and start our
COVA clinical program in France. We have been working for many years with the
team at La Pitié-Salpêtrière Hospital, which is linked with Sorbonne
University's medical school, a long-standing partner of Biophytis. The
continued surge of COVID-19 cases in France, Europe and the Americas and
subsequent hospitalizations, re-emphasizes the emergency of finding innovative
treatments against the pandemic (even while a vaccine is being rolled-out).

We project enrollment of the 50 patients required for the first part of the
study to complete in the coming weeks. Topline results of the COVA trial are
expected in Q2 2021."

About BIOPHYTIS

Biophytis SA is a clinical-stage biotechnology company specialized in the
development of therapeutics that slow the degenerative processes associated
with aging and improve functional outcomes for patients suffering from
age-related diseases, including severe respiratory failure in patients
suffering from COVID-19.

Sarconeos (BIO101), our leading drug candidate, is a small molecule,
administered orally, being developed as a treatment for sarcopenia in a Phase 2
clinical trial in the United States and Europe (SARA- INT). It is also being
studied in a clinical two-part Phase 2/3 study (COVA) for the treatment of
severe respiratory manifestations of COVID-19 in Europe, Latin America and the
US.

A pediatric formulation of Sarconeos (BIO101) is being developed for the
treatment of Duchenne Muscular Dystrophy (DMD).

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 Annual
2019 Report and the Company's Half Year 2020 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 - First Patient Enrolled in France in COVA, an International Phase 2/3 Clinical Trial with Sarconeos (BIO101) for the Treatment of COVID-19 Related Respiratory Failure

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