Biophytis 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

Biophytis today announces the recommendation by the Data Monitoring Committee (DMC) to continue the Phase 2-3 COVA study without any modification of the protocol, after the interim efficacy data were found in the promising zone in the Interim Analysis 2 based on 155 COVID-19 patients hospitalized with respiratory failure. This recommendation completes previous safety evaluation performed by DMC last August (Press Release August, 16th) that confirmed the good safety profile of Sarconeos (BIO101).

  • The independent DMC (Data Monitoring Committee) recommends continuation of Part 2 of the Phase 2-3 Study (“the COVA Study”) without any protocol amendment

  • The second Interim Analysis (“IA2”) based on 155 hospitalized patients shows no futility, with efficacy results in the 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 the evolution of the pandemic in Q1 2022

Stanislas Veillet, CEO of Biophytis declared: “We are thrilled with the DMC recommendation following the second Interim Analysis to continue the COVA study unmodified. The DMC recommendation suggests that the trial is well on track to lead to conclusive efficacy results at final analysis. We hope that Sarconeos (BIO101) will become one of the first drug candidates able to restore breathing capabilities of hospitalized patients in severe conditions, and therefore avoiding their admission to ICUs. The whole Company is now focused on the next milestones, ie complete the trial as soon as possible, as well as its industrial scaling up and regulatory approval in Europe, USA and Brazil. We want to be ready for commercialization of our Sarconeos (BIO101) in COVID-19 first half of 2022”.