Biophytis Completed Recruitment of 155 Participants to the COVA Phase 2-3 Study
with Sarconeos (BIO101) in COVID-19 allowing the 2nd Interim Analysis
* This 2nd interim analysis is to be performed by the independent DMC (Data
Monitoring Committee) based on safety and efficacy data
* The Company is to report the recommendation from the DMC based on its review
of second interim analysis by end of Q2 2021, subject to any COVID-19-related
Paris, France, Cambridge (Massachusetts, United States), May 12, 2021 - 8AM CET
- Biophytis SA (Nasdaq CM: BPTS, Euronext Growth Paris: ALBPS), ("Biophytis"
or the "Company"), - Biophytis SA (NasdaqCM: BPTS, 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 it has recruited the 155th
participant for Part 2 of its COVA Phase 2-3 study of Sarconeos (BIO101) in
patients infected with COVID-19.
Recruitment of the 155th participant allows for the independent Data Monitoring
Committee (DMC) to conduct its second interim analysis, based on safety and
efficacy data, for the continuation of the trial in case of favorable results.
The Company is to report the recommendations of the DMC based on its review of
the second interim analysis results by the end of Q2 2021.
The DMC previously delivered a favorable opinion in March on the safety of
Sarconeos (BIO101) in COVID-19 and recommended the continuation of the study
into Part 2, following the scheduled interim analysis of the 50 participants in
Part 1 of the COVA study.
Recruitment into Part 2 of the study continues to proceed in France and Brazil
to complete enrollment of 310 participants, with the aim of filing for
Emergency Use Authorization with the US Food and Drug Administration (FDA) and
Conditional Approval with the European Medicines Agency (EMA) in Q3 2021. The
final study results are expected in Q3 2021, subject to any COVID-19-related
delays and the impact of the pandemic.
Stanislas Veillet, President and CEO of Biophytis, said: "Completion of
recruitment of the 155th patient is an important milestone for Biophytis as we
will be able to measure the therapeutic potential of Sarconeos (BIO101) in
COVID-19. We are now looking forward to the second interim analysis, and hope
the DMC will recommend the continuation of our Phase 2-3 COVA trial upon
favorable review of the safety and efficacy data."
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
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
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 participant 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 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
Sophie Baumont/Chris Maggos
T: +33 6 27 74 74 49