Regeneron-Roche Post Encouraging New Data For COVID-19 Antibody Cocktail

  • Regeneron Pharmaceuticals Inc REGN and Roche Holdings AG RHHBY announced positive data from Phase 2/3 2066 study of Ronapreve (casirivimab and imdevimab) or REGN-COV in hospitalized COVID-19 patients. 
  • Related: WHO Backs Regeneron COVID-19 Antibody Cocktail As It Calls For Equal Access.
  • The trial met its primary endpoint and showed that REGEN-COV significantly reduced viral load in hospitalized patients within seven days of treatment without mounting their antibody response (seronegative) and required low-flow or no supplemental oxygen.
  • The full results of the study will be presented at ID Week 2021 today.
  • In this trial, patients who received REGEN-COV experienced a 36% reduced risk of dying within 29 days of treatment. In patients who were seronegative when they entered the trial, the risk was reduced by 56%. 
  • In a safety analysis involving 2,007 patients (REGEN-COV=1,340, placebo=667) serious adverse events occurred in 21% REGEN-COV patients and 26% placebo patients. 
  • Infusion-related and hypersensitivity reactions were more common among REGEN-COV patients (2% and 1% respectively) than placebo patients (1% and less than 0.5%, respectively). 
  • The study also reported results supportive of the much larger UK RECOVERY trial in hospitalized patients.
  • It showed that patients who received Ronapreve (2,400 mg or 8,000 mg) along with standard care experienced numeric improvements across all clinical endpoints assessed, compared to standard care alone. 
  • Comparable clinical outcomes were recorded with both 2,400 mg and 8,000 mg doses. No new safety signals were identified.
  • Read Next: FDA Approves Regeneron - Roche's COVID-19 Antibody Cocktail For Post-Exposure Prophylaxis.
  • Price Action: REGN stock closed at $606.70 on Wednesday.
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Posted In: BiotechNewsHealth CareGeneralBriefsCOVID-19 CoronavirusPhase 2 TrialPhase 3 Trial
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