End of the road for US trial of Kevzara as COVID-19 therapy

The US Phase III trial of rheumatoid arthritis drug Kevzara (sarilumab) in COVID-19 patients requiring mechanical ventilation did not meet its primary and key secondary endpoints when Kevzara was added to best supportive care compared to best supportive care alone (placebo).

The drug’s developer saw their shares dip on the news, with Sanofi (Euronext: SAN) down 1.7% in after-hours trading yesterday, and Regeneron Pharmaceuticals (Nasdaq: REGN) down 2.2 at $622.45 by the closing bell.

Minor positive trends were observed in the primary pre-specified analysis group (critical patients on Kevzara 400mg who were mechanically ventilated at baseline) that did not reach statistical significance and these were countered by negative trends in a subgroup of critical patients who were not mechanically ventilated at baseline. In the primary analysis group, adverse events were experienced by 80% of Kevzara patients and 77% of placebo patients. Serious adverse events that occurred in at least 3% of patients and more frequently among Kevzara patients were multi organ dysfunction syndrome (6% Kevzara, 5% placebo) and hypotension (4% Kevzara, 3% placebo).