BIOPHYTIS (EPA:ALBPS) - Biophytis gives updates on its Phase 2-3 COVA study on COVID-19

Transparency directive : regulatory news

22/03/2021 08:00

Press Release

Biophytis gives updates on its Phase 2-3 COVA study on COVID-19

* The Company receives a favorable opinion from the DMC on the safety of
Sarconeos (BIO101) in the COVA study following first interim analysis
* Patient enrollment has now reached 97 of the 155 planned for the second
interim analysis
* A total of 28 clinical centers are now opened and recruiting in the United
States, Brazil, France & Belgium.

Paris (France), Cambridge (Massachusetts, US) - March 22, 2021, 08:00 a.m. CET
- Biophytis SA (Nasdaq CM: BPTS, Euronext Growth Paris: ALBPS), ("Biophytis" or
the "company"), a clinical-stage biotechnology company focused on the
development of therapeutics that are aimed at slowing the degenerative
processes associated with aging and improving functional outcomes for patients
suffering from age-related diseases, including severe respiratory failure in
patients suffering from COVID-19, announces that the independent Data
Monitoring Committee (DMC) for the COVA study has delivered a favorable opinion
on the safety of Sarconeos (BIO101) in patients infected with COVID-19,
following the scheduled interim analysis of the 50 participants from Part 1 of
the study, as well as the progression of patients enrollment, which has now
reached 97 of the 155 planned for the second interim analysis.

A total of 28 clinical centers of the 30 targeted are now opened and recruiting
in the United States, Brazil, France and Belgium. Upon the second interim
analysis, based on the safety and efficacy data from 155 patients, the DMC will
re assess the total size of the cohort, estimated today at 310 patients, and
the continuation of the trial.

Stanislas Veillet, Chief Executive Officer of Biophytis, said: "In the
persistent pressured healthcare context of COVID-19, we are extremely pleased
with the opinion delivered by the DMC on the safety of Sarconeos (BIO101) in
the framework of our COVA trial. This opinion allows us to push our mission
forward with continued recruitment into Part 2 of the COVA study. We have now
enrolled 97 out of the targeted 155 participants planned for the second interim
analysis. Our 28 sites are recruiting in the United States, Brazil, France and
Belgium. Our next milestone is now the second interim analysis, where we will
get from DMC the green light for continuing our trial, as well as the final
number of patients needed for the study".

The COVA clinical program (clinicaltrials.gov identifier NCT04472728) is a
global, multicenter, double-blind, placebo-controlled, group-sequential and
adaptive design two-part study. It is a Phase 2-3 study that assesses Sarconeos
(BIO101) in patients aged 45 and older, hospitalized with severe respiratory
manifestations of COVID-19

Part 1 of the COVA Study is a Phase 2 exploratory proof of concept study
providing preliminary data on the safety, tolerability and activity of
Sarconeos (BIO101) in 50 hospitalized patients with severe respiratory
manifestations related to COVID-19.

Part 2 of the COVA Study is a Phase 3 randomized study investigating 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).

The study results (Part 1 and Part 2) are expected in Q2 2021, subject to any
COVID-19-related delays and the impact of the current pandemic.

About BIOPHYTIS
Biophytis SA is a clinical-stage biotechnology company specialized in the
development of therapeutics that are aimed at slowing the degenerative
processes associated with aging and improving 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 Euronext Growth (Ticker: ALBPS -ISIN:
FR0012816825) and ADSs are listed on Nasdaq Capital Market (Ticker BPTS - ISIN:
US09076G1040).

For more information visit www.biophytis.com

Disclaimer
This press release contains forward-looking statements. Forward-looking
statements include all statements that are not historical facts. In some cases,
you can identify these forward-looking statements by the use of words such as
"outlook," "believes," "expects," "potential," "continues," "may," "will,"
"should," "could," "seeks," "predicts," "intends," "trends," "plans,"
"estimates," "anticipates" or the negative version of these words or other
comparable words. Such forward- looking statements are based on assumptions
that Biophytis considers to be reasonable. However, there can be no assurance
that the statements contained in such forward-looking statements will be
verified, as these statements are subject to various risks and uncertainties,
including, without limitation the risks described in our annual report on Form
2-F for the fiscal year ended December 31, 2020 and other filings with the U.S.
Securities and Exchange Commission. The forward-looking statements contained in
this press release are also subject to risks not yet known to Biophytis or not
currently considered material by Biophytis. Accordingly, there are or will be
important factors that could cause actual outcomes or results to differ
materially from those indicated in these statements. In France, please also
refer to the "Risk Factors" section of the Company's 2020 Full Year Report
available on the Biophytis website (www.biophytis.com). We undertake no
obligation to publicly update or review any forward-looking statement, whether
as a result of new information, future developments or otherwise, except as
required by law.

Biophytis Contact
Evelyne Nguyen, CFO
E: evelyne.nguyen@biophytis.com

Media contact
LifeSci Advisors
Sophie Baumont/Chris Maggos/John Hodgson
E: sophie@lifesciadvisors.com
T: +33 6 27 74 74 49

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