Phase III outcomes trial of REGEN-COV meets primary and secondary endpoints in COVID-19.- Regeneron Pharma

Regeneron Pharmaceuticals announced positive topline results from the largest trial to date assessing a COVID-19 treatment in infected non-hospitalized patients (n=4,567). This definitive Phase III outcomes trial in high-risk non-hospitalized COVID-19 patients met its primary endpoint, showing the investigational REGEN-COV (casirivimab with imdevimab) significantly reduced the risk of hospitalization or death by 70% (1,200 mg intravenous [IV]) and 71% (2,400 mg IV) compared to placebo. REGEN-COV also met all secondary endpoints in the Phase III outcomes trial, including the ability to reduce symptom duration. In addition, a companion Phase II trial showed that even the lowest doses tested (IV: 300 mg; subcutaneous [SC]: 600 mg) had significant viral load reductions over the first 7 study days, comparable to the 2,400 mg and 1,200 mg IV doses. A safety assessment was conducted on all available patient data up to day 169, and identified no new safety signals. Serious adverse events (SAEs) were largely related to COVID-19 and occurred in 1.1% of patients in the 1,200 mg group, 1.3% in the 2,400 mg group and 4.0% in the placebo group.