Biophytis To Restart Recruitment In US Centers For COVID-19 Trial

Biophytis SA BPTS has announced that patient recruitment in the U.S., 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 with Sarconeos (BIO101) for COVID-19.
The COVA study has enrolled 216 patients hospitalized with severe pneumonia from COVID-19 infection in 35 U.S., Brazil, France, and Belgium centers.
In addition, five new clinical centers are expected to rapidly start recruiting patients in Brazil and the U.S., over a total target of 15 additional clinical centers.
The end of recruitment and final results of the COVA study is expected during Q1 of 2022.
FDA Emergency Use Authorization in the U.S. and Conditional Marketing Authorization in Europe for Sarconeos (BIO101) for COVID-19 could be obtained as early as in Q2 of 2022.
Price Action: BPTS shares are up 9.12% at $6.10 during the market session on the last check Monday.