Biophytis SA (NasdaqCM: BPTS, Euronext Growth Paris: ALBPS), a clinical-stage biotechnology company focused on the development of therapeutics that slow the degenerative processes associated with aging and improve functional outcomes for patients suffering from age-related diseases, including severe respiratory failure in patients suffering from COVID-19, 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).
Dr. Muriel Lins, COVA trial coordinator in Belgium declared: “with the emergence of the delta variant in Europe, we are happy that this second interim analysis leads to continuation of the COVA study. Patient recruitment will be continued intensively in Belgium and in France to reach full completion of the study.”
Dr. Girish Nair COVA trial coordinator in USA declared: “USA Investigators are welcoming the continuation of the COVA trial as a very good opportunity to restart recruitment when the DMC meeting outcome will be shared with the FDA.”
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, i.e. 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.”
The COVA DMC has met on September 10th 2021 for the Interim Analysis 2 to review the safety and efficacy data of the first 155 randomized patients. The DMCs recommendation is based on the promising zone analysis published by Mehta and Pocock in 2011, and especially on the conditional power for the primary endpoint evaluated with interim analysis. The COVA study primary endpoint is the proportion of participants with “negative events” of either the following: all cause mortality; respiratory failure defined as requiring mechanical ventilation or Extracorporeal Membrane Oxygenation (ECMO).
Interim analysis 2 results shows that the study is currently in the promising zone, therefore the sample size remains unmodified per the current protocol i.e. between 310 and 465 patients, indicating that Sarconeos (BIO101) remains a candidate treatment for acute respiratory failure associated with COVID-19. The study is not in the unfavourable zone, that would have led to stopping for futility, and has not demonstrated statistically significant efficacy yet, which would have led to early stopping for efficacy.
The DMC recommendation will be shared with all regulatory agencies to continue patient recruitment. 35 clinical centers are now opened to recruit COVID-19 patients in the USA, Brazil, France and Belgium. Today, 200 patients are randomised in COVA trial. To accelerate recruitment, 15 additional sites will be opened in USA, Brazil, France, UK and Belgium, where the COVA study is already approved. With this new network of 50 sites, top line results of the study are expected in Q1 2022, depending on the evolution of the pandemic.
The COVA clinical program (clinicaltrials.gov identifier: NCT04472728) is a global, multicentre, double-blind, placebo-controlled, group-sequential and adaptive design two-part Phase 2-3 study assessing Sarconeos (BIO101) in patients aged 45 and older, hospitalized with severe respiratory manifestations of COVID-19. Part 1 of the COVA Study is a Phase 2 exploratory proof of concept study providing preliminary data on the safety, and tolerability and efficacy of Sarconeos (BIO101) in 50 hospitalized patients with severe respiratory manifestations related to COVID-19. Part 2 of the COVA Study is a Phase 3 pivotal randomized study investigating the safety and efficacy of Sarconeos (BIO101) on the respiratory function of 310 to 465 COVID-19 patients (including the 50 patients from Part 1 of the study).