IC43: Phase II/III halted

Valneva halted enrollment in a double-blind, placebo-controlled, European Phase II/III trial evaluating 2 doses of IC43 plus hospitals' choice of standard of care (SOC) after a DMC interim analysis of 394 patients met the pre-specified criterion for futility in regards to the primary endpoint. Valneva declined to disclose the criterion for futility, but said the trial will require protocol amendments "to have a good chance" to meet its primary endpoint. Valneva said there was a "clinically meaningful" difference in all-cause mortality rates at day 28 - the primary endpoint - between the IC43 plus SOC and placebo plus SOC arms and that no safety concerns were observed. The company said it will discuss possible trial modifications with the DMC and regulatory authorities and hopes to re-initiate the trial early next year. Under the original protocol, the trial planned to enroll 800 ventilated intensive-care unit patients to receive SOC plus 2 doses of IC43 7 days apart or placebo. ...