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.
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