Clear efficacy for REGEN-COV in Phase III leads IDMC to recommend no placebo group enrollement
US biotech Regeneron Pharmaceuticals (Nasdaq: REGN) today announced changes to the Phase III trial assessing investigational REGEN-COV (casirivimab with imdevimab) in non-hospitalized patients (outpatients) with COVID-19, following recommendations from the Independent Data Monitoring Committee (IDMC).
The IDMC found clear clinical efficacy on reducing the rate of hospitalization and death with both the 1,200mg and 2,400mg doses of REGEN-COV compared to placebo, and recommended stopping enrollment into the placebo group.
Regeneron is following the IDMC recommendation and will immediately stop enrolling patients in the placebo group. The company has not yet had access to any of the unblinded data, including the relative treatment benefit of the 1,200mg and 2,400mg doses, and will share detailed results when available in March 2021.
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