Biophytis announces US centers to restart recruitment for the COVA phase 2-3 study with Sarconeos (BIO101) in COVID-19
Biophytis announces that patient recruitment in the United States, paused in May while waiting for results of the Interim Analysis 2, has restarted. The Data Monitoring Committee (DMC) had recommended in September from the Interim Analysis 2 the continuation of the COVA study unmodified based on results showing the efficacy of the treatment with Sarconeos (BIO101) in the promising zone and no futility of the study. The FDA confirmed that, as part of the protocol and following the DMC recommendation, the enrollment in the USA could restart.
Stanislas Veillet, CEO of Biophytis, stated: “We are delighted in receiving the confirmation from the FDA that we can restart enrollment in the USA. The whole Company is committed to finalize the COVA study as soon as possible, to confirm the promising efficacy seen in the Interim Analysis 2, and the re-opening of US centers will strongly contribute to our patient recruitment. We do believe, at the beginning of the 5th wave in Europe, that COVID-19 is becoming endemic and will persist over time. Sarconeos (BIO101) might bring a real therapeutic solution for patients hospitalized with severe respiratory manifestations, with no pharmacological treatment option today.”
To date the COVA study has enrolled 216 patients hospitalized with severe pneumonia from Covid-19 infection in 35 centers in the USA, Brazil, France and Belgium. In addition, 5 new clinical centers are expected to rapidly start recruiting patients in Brazil and in the USA, over a total target of 15 additional clinical centers. The Company will count on an overall network of around 50 centers to complete patient enrollment for the study (between 310 and 465 patients).
End of recruitment and final results of the COVA study are expected, depending on the evolution of the pandemic, during the first quarter of 2022.
Emergency Use Authorization in the United States and Conditional Marketing Authorization in Europe for Sarconeos (BIO101) in the treatment of Covid-19 could be obtained as early as in the second quarter of 2022.