BIOPHYTIS (EPA:ALBPS) - Biophytis Announces Expansion of Patient Recruitment for Part 2 of the Phase 2-3 COVA Trial (“COVA Study”) following Regulatory Authorities approvals in France and Belgium

Transparency directive : regulatory news

17/02/2021 08:00

Press Release

    Biophytis Announces Expansion of Patient Recruitment for Part 2 of the
Phase 2-3 COVA Trial ("COVA Study") following Regulatory Authorities approvals
                             in France and Belgium

* Clinical centers in France and Belgium will begin recruitment for Part 2 of
  the COVA Study following authorization from Regulatory Authorities
* These approvals follow the previous authorizations obtained from Brazil and
  the United States in most clinical centers
* Interim Analysis of Part 1 is expected in Q1 2021
* Results from the full study (Part 1 and Part 2) are expected in Q2 2021

Paris (France), Cambridge (Massachusetts, U.S.), February 17, 8:00 a.m. CET -
Biophytis SA (Euronext Growth Paris: ALBPS), 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, today announces that
patient recruitment will begin in France and Belgium for Part 2 of its COVA
Study assessing Sarconeos (BIO101) as a potential treatment for acute
respiratory failure associated with COVID-19.

Following the Data Monitoring Committee ("DMC") recommendation to begin the
recruitment for Part 2, authorization was obtained from Regulatory Authorities
(national regulatory agencies and/or central IRB and/or local Ethics
Committees) in Brazil and the USA for most clinical centers in the two
countries for the start of Part 2. Similar authorizations are now obtained in
France and in Belgium, from the respective Regulatory Authorities.

That brings to four the number of countries in which the COVA Study is now
recruiting for Part 2: France, Belgium, Brazil and the United States, following
the completion of patient enrollment for Part 1, which is now achieved with 50
participants.

Stanislas Veillet, Chief Executive Officer  of  Biophytis,  said: "We are
extremely pleased that Part 2 of the COVA Study has now also been authorized in
France and Belgium."

The COVA Study (clinicaltrials.gov identifier: NCT04472728 and EudraCT
identifier: 2020-001498-63) is a global, multicenter, double-blind,
placebo-controlled, group-sequential, and adaptive design two-part Phase 2-3
study assessing 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, and tolerability and activity of
Sarconeos (BIO101) in 50 hospitalized patients with severe respiratory
manifestations of COVID-19. The interim analysis of Part 1 is expected in Q1
2021, subject to any COVID-19 related delays and the impact of the current
pandemic on our operational capabilities.

Part 2 of the COVA Study is a Phase 3 pivotal randomized study investigating
the safety and efficacy of Sarconeos (BIO101) on the respiratory function from
310 COVID-19 patients (including the 50 patients from Part 1 of the study). The
full study results (Part 1 and Part 2) are expected in Q2 2021, subject to any
delays in patient recruitment or retention, interruptions in sourcing or supply
chain, regulatory authorizations and procedures, 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 the Euronext Growth Paris market (Ticker:
ALBPS -ISIN: FR0012816825). 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. These forward- looking statements include statements
regarding Biophytis' anticipated timing for its Interim Analysis of Part 1 and
release of full study results. 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, which are subject to various risks and uncertainties including,
without limitation, delays in patient recruitment or retention, interruptions
in sourcing or supply chain, its ability to obtain the necessary regulatory
authorizations, COVID-19-related delays, and the impact of the current pandemic
on the Company's clinical trials. 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 Annual 2019 Report and the
Company's Half Year 2020 Report available on 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 for Investor Relations
Evelyne Nguyen, CFO
E: evelyne.nguyen@biophytis.com

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

Investor Relations
LifeSci Advisors, LLC
Sandya von der Weid
E: svonderweid@lifesciadvisors.com
T: +41 78 680 05 38

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BIOPHYTIS (EPA:ALBPS) - Biophytis Announces Expansion of Patient Recruitment for Part 2 of the Phase 2-3 COVA Trial (“COVA Study”) following Regulatory Authorities approvals in France and Belgium

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