Biophytis provides updates on Sarconeos (BIO101) clinical development
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Biophytis provides updates on Sarconeos (BIO101)
Paris (France), Cambridge (Massachusetts, United States), April 7th 2022, 8 A.M - Biophytis SA (NasdaqCM: BPTS, Euronext Growth Paris: ALBPS) (the "Company" or "Biophytis"), a clinical-stage biotechnology company specialized in the development of therapeutics that slow the degenerative processes associated with aging, including severe respiratory failure in patients suffering from COVID-19, today provides an update on its most advanced clinical studies.
In October 2021, the Company announced that Sarconeos (BIO101) at the highest dose of 350 mg bid demonstrated an increase of 0.09 meter per second (m/s) in the FAS population and of 0.10 m/s in the PP population compared to placebo, for the 400MWT in gait speed, after 6 months of treatment. This result is considered meaningful as the Minimal Clinically Important Difference (MCID) for the 400MWT in sarcopenia is 0.1 m/s.
However, due to restrictions during the pandemic, only 106 patients could perform the 400m walk test at the end-of-treatment visit, which was the primary endpoint of our study which resulted in 55% of loss of efficacy data.
On January 24, 2022, a meeting between the Company and the FDA was held. During which we discussed conducting additional dose-finding and further definition of the proposed population and indication, as well as CMC (chemistry, manufacturing, and control section) data to be submitted, and the regulatory non-clinical plan.
We are currently assessing FDA comments and recommendations and preparing for the submission of a seamless design phase 2-3 with the objective of having a First Patient In by H2 2022.
We anticipate to have other discussions with FDA in Q3 2022 and with EMA in H1 2022 to get scientific advice, including on the results of the Phase 2b study and potential progression into Phase 2-3.
Stanislas Veillet, CEO of Biophytis, declares: "In 2021 Sarconeos BIO(101) reached a key milestone with the end of SARA phase 2 trial in Sarcopenia. We achieved the study with encouraging results, mostly in the Per Protocol population. Unfortunately it was lacking statistical power due to regulatory restrictions during the pandemic. We are now exchanging with FDA and soon with EMA for the prepation our phase 2-3 study. Assuming authorizations are obtained, we expect to have our FPI by end of H2 2022."
The Data Monitoring Committee (DMC) had recommened in September 2021 the continuation of the COVA study unmodified based on the results of the second Interim Analysis on 155 patients, showing the efficacy of the treatment with Sarconeos (BIO101) in the promising zone and no futility of the study. The initial target for the study was the recrtment of 310 to 465 patients.
Since April 2020, 237 patients meeting the study criteria have been enrolled in the trial in France, the United States, Belgium and Brazil, in 37 clinical centers. Since the end of 2021, global immunity in Europe, US, and Brazil, as well as vaccination campaigns have strongly progressed. In addition, the number of hospital admissions has also decreased due to the reduced severity of the Omicron variant. As a result, the Company has experienced significant slow-downs in the speed of patient recruitment during the last months.
In this context after consultation of its experts for the study as well as its medical & scientific advisors, the Company has stopped the enrollment at the 237th patient, and is proceeding to close its clinical centers in Q2 2022, in order to report the results of the study in Q3 2022.
Stanislas Veillet, CEO of Biophytis, stated : "Our clinical trial is inherently dependent on the evolution of the pandemic, which is, after the 5th wave, declining globally in the United States, Europe and Brazil. We are adapting to this situation in giving priority to obtaining the study's results. Stopping the recruitement is an important step that should enable us to announce COVA results during Q3 2022. We are convinced that COVID-19 is becoming endemic and will persist over time. We have yet to demonstrate that Sarconeos (BIO101) might bring a real therapeutic solution for patients hospitalized with severe respiratory manifestations, with no pharmacological treatment option as of today".
As a reminder, the COVA clinical programme (identifier clinicaltrials.gov: NCT04472728) is an international, multi-centre, double-blind, placebo-controlled, group-sequential and adaptive two-part study. It is a phase 2-3 study evaluating Sarconeos (BIO101) in patients aged 45 years and older, hospitalised with severe respiratory manifestations of COVID-19. Part 1 of the COVA study is an exploratory Phase 2 proof-of-concept study designed to provide preliminary data on the safety, tolerability and efficacy of Sarconeos (BIO101) in 50 hospitalised patients with severe respiratory failure in patients suffering from COVID-19. Part 2 of the COVA study is a randomised phase 3 study investigating the safety and efficacy of Sarconeos (BIO101) on respiratory function in 310 to 465 COVID-19 patients (including the 50 patients from the first part of the study).
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, 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 with a positive Phase 2 clinical trial performed 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 ordinary shares are listed on Euronext Growth (Ticker: ALBPS -ISIN: FR0012816825) and the ADS (American Depositary Shares) are listed on Nasdaq (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. 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. 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 also refer to the "Risks and uncertainties the Company is to face" section from the Company's 2021 Full Year Report and as exposed in the "Risks Factors" section of form 20-F as well as other forms to be filed respectively with AMF and with the SEC (Securities and Exchange Commission, USA). 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
Philippe Rousseau, CFO
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