BIOPHYTIS (EPA:ALBPS) - Biophytis Secures the Manufacturing of Sarconeos (BIO101) for COVID-19 with a Global CDMO & Announces the Next Milestones for the COVA Phase 2-3 Study

Transparency directive : regulatory news

30/06/2021 23:00

Press release

Biophytis Secures the Manufacturing of Sarconeos (BIO101) for COVID-19 with a
Global CDMO & Announces the Next Milestones for the COVA Phase 2-3 Study

* The Company signed contracts for the manufacturing of registration batches in
view of the potential application for Emergency Use Authorization to FDA and/or
Conditional Marketing Authorization to EMA
* The 155th patient has completed treatment in Part 2 of the COVA Phase 2-3
study and results of second interim analysis are expected in Q3 2021
* The full results of the study and the filing for market authorization are now
scheduled for Q4 2021.

Paris, France, Cambridge (Massachusetts, United States), June 30th 2021, 11 pm
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 today announces it has secured contracts with
a major global Custom Development and Manufacturing Organization (CDMO) for the
manufacturing of registration batches of Sarconeos (BIO101). These contracts
were signed in preparation of the potential filing of the product in COVID-19
for Emergency Use Authorization with FDA, or Conditional Marketing
Authorization with EMA. The Company also announces the following next
milestones:

- With the 155th patient for Part 2 of the COVA Phase 2-3 study with Sarconeos
(BIO101) in patients infected with COVID-19 having completed the treatment on
May 24 2021, data management and bio statistic activities are ongoing before
submitting the results to the DMC (Data Monitoring Committee). Results of this
second interim analysis (IA2) as regards to safety and efficacy are now
expected in Q3 2021. The DMC previously delivered a favorable opinion in March
2021 on the safety of Sarconeos (BIO101) in COVID-19, following the first
interim analysis of the 50 participants in Part 1 of the COVA study.

- Beyond the second interim analysis based on 155 patients, the Company is
pursuing the recruitment of patients in the context of pandemic slow-down and
progress of vaccination campaign in Europe and the USA. 176 patients have been
recruited in total over the 310 required for the release of the full results.
Top line results for the full study are now expected in Q4 2021, in view of a
potential filing for Emergency Use Authorization and Conditional market
Approval applications respectively with FDA and EMA by year end.
Commercialization should then start beginning of 2022.

Stanislas Veillet, Chief Executive Officer of Biophytis, said: "We are very
pleased to have secured with a world-renowned manufacturer a new contractual
framework in order to get us prepared for the next steps of Sarconeos (BIO101).
Our goal is to rapidly scale up our supply capacity, should we receive approval
for Sarconeos (BIO101) in COVID-19. We also progressed in the clinics with our
last patient counting for the second interim analysis (IA2) having terminated
his treatment. We are now very concentrated in getting the results for this IA2
by Q3 2021. Assuming positive data from the COVA trial, filing for Emergency
Use Authorization with the FDA, and Conditional Marketing Authorization with
EMA is now planned by the end of the year and if granted, commercialization
could possibly start by the beginning of 2022. The new timelines do not change
our commitments towards bringing a new treatment to hospitalized patients with
COVID-19 and have no impact on Biophytis' overall strategy. We do believe
despite vaccination campaigns, the medical need will persist. Therefore we are
still actively engaged in the fight against this pandemic."

The COVA clinical program (clinicaltrials.gov identifier NCT04472728) is a
global, multicenter, double-blind, placebo-controlled, group-sequential and
adaptive design two-part study. This Phase 2-3 study assesses Sarconeos
(BIO101) in patients aged 45 and older, hospitalized with severe respiratory
manifestations of COVID-19. The 155 participants were recruited in 34 centers
in 4 countries: the US, Brazil, France and Belgium.

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 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
participants, or up to 465 participants, including the 50 participants from
Part 1 of the study.

The final sample size will depend upon DMC recommendations from the second
interim analysis.

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. These forward-looking statements include statements regarding
Biophytis' anticipated timing for its various Sarconeos (BIO101) clinical
trials and expectations regarding commercialization. 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. Please refer to the "Risk Factors" section of the Company's Annual
2020 Report available on BIOPHYTIS website (www.biophytis.com) and to the risks
discussed in the Company's registration statement on Form F-1 and other reports
filed with the Securities and Exchange Commission (the "SEC"). 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
evelyne.nguyen@biophytis.com

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

Investor Relations
LifeSci Advisors, LLC
Ligia Vela-Reid
E: lvela-reid@lifesciadvisors.com

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BIOPHYTIS (EPA:ALBPS) - Biophytis Secures the Manufacturing of Sarconeos (BIO101) for COVID-19 with a Global CDMO & Announces the Next Milestones for the COVA Phase 2-3 Study