DMC Recommends Biophytis Continue Sarconeos COVID-19 Study

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  • The Data Monitoring Committee (DMC) has recommended Biophytis SA BPTS to continue patient recruitment into part 2 of Phase 2-3 COVA Study in COVID-19, with the protocol unmodified after reviewing of safety data.
  • The COVA clinical program is assessing Sarconeos (BIO101) in patients aged 45 and older hospitalized with severe respiratory manifestations of COVID-19.
  • The independent DMC meeting was dedicated to analyzing safety data from the first 155 randomized patients. 
  • The DMC will review the efficacy data of the 155 patients in Q3 2021 as part of the second Interim analysis to recommend futility and final sample size.
  • The Company is progressing to complete the recruitment of the 310 patients and report top-line results in Q4 of 2021.
  • Price Action: BPTS shares closed 1.27% higher at $8.54 on Friday.
  • Related content: Benzinga's Full FDA Calendar.
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Posted In: BiotechNewsHealth CareFDAGeneralBriefsCOVID-19 CoronavirusPhase 2Phase 3 Trial
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