Pfizer Kick Starts Late-Stage Study For COVID-19 Oral Antiviral For Post-Exposure Prophylaxis

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  • Pfizer Inc PFE has started the Phase 2/3 EPIC-PEP study to evaluate its oral antiviral candidate PF-07321332, co-administered with a low dose of ritonavir, for the prevention of COVID-19 infection. 
  • Related: COVID-19 Oral Antiviral Drug From Pfizer Could Be Available By 2021, Says CEO: CNBC.
  • This Phase 2/3 trial is part of a global program and enrolls adult individuals who live in the same household as individuals with a confirmed symptomatic SARS-CoV-2 infection.
  • The Phase 2/3 EPIC-PEP trial will enroll up to 2,660 healthy adult participants aged 18 and older. 
  • Participants will be randomly assigned to receive PF-07321332/ritonavir or placebo orally twice daily for 5 or 10 days. 
  • The primary objective will assess safety and efficacy to prevent confirmed SARS-CoV-2 infection and its symptoms through Day 14. 
  • In addition to this study, the global EPIC program consists of multiple ongoing trials, including one in SARS-CoV-2 infected patients at high risk of severe illness (including hospitalization or death), which began in July 2021.
  • Another trial is in infected patients at standard risk (i.e., do not have risk factors for severe illness), which began in August 2021.
  • Price Action: PFE stock is down 0.30% at $43.81 during the market session on the last check Monday.
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Posted In: BiotechNewsHealth CareGeneralBriefsCOVID-19 CoronavirusPhase 2 TrialPhase 3 Trial
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