Brief: Biophytis Says DMC Recommends Continuation Of Phase 2/3 COVA Study Without Protocol Amendment

Biophytis SA

15/09/2021 07:07

Sept 15 (Reuters) - BIOPHYTIS SA  ALBPS.PA :
    * ANNOUNCES DMC SECOND INTERIM ANALYSIS EFFICACY RESULTS IN
THE
PROMISING ZONE ALLOWING CONTINUATION OF PHASE 2/3 COVA STUDY
WITH SARCONEOS (BIO101) IN COVID-19
    * INDEPENDENT DMC (DATA MONITORING COMMITTEE) RECOMMENDS
CONTINUATION OF PART 2 OF PHASE 2-3 STUDY (" COVA STUDY")
WITHOUT ANY PROTOCOL AMENDMENT
    * SECOND INTERIM ANALYSIS ("IA2") BASED ON 155 HOSPITALIZED
PATIENTS SHOWS NO FUTILITY, WITH EFFICACY RESULTS IN PROMISING
ZONE, INDICATING THAT BIO101 REMAINS A CANDIDATE TREATMENT FOR
ACUTE RESPIRATORY FAILURE ASSOCIATED WITH COVID-19
    * TO DATE, 200 PATIENTS HAVE BEEN ENROLLED IN COVA STUDY AND
15
ADDITIONAL SITES IN USA, BRAZIL, FRANCE, UK AND BELGIUM WILL BE
OPENED TO ACCELERATE PATIENT RECRUITMENT AND REPORT TOP LINE
RESULTS DEPENDING ON EVOLUTION OF PANDEMIC IN Q1 2022
    * WE WANT TO BE READY FOR COMMERCIALIZATION OF OUR SARCONEOS
(BIO101) IN COVID-19 FIRST HALF OF 2022
    * TOP LINE RESULTS OF STUDY ARE EXPECTED IN Q1 2022,
DEPENDING ON
EVOLUTION OF PANDEMIC

Source text for Eikon:  ID:nGNXjH2zY 
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