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     304  0 Kommentare 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 and CAMBRIDGE, Mass., March 22, 2021 (GLOBE NEWSWIRE) -- 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”.

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    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 analysisPatient enrollment has now reached 97 of the 155 planned for the second interim analysisA total of 28 …