IC43: Phase II/III ongoing

This quarter, Valneva plans to resume enrollment of an additional 400 ventilated intensive care unit (ICU) patients in a double-blind, placebo-controlled, European Phase II/III trial evaluating 2 doses of IC43 plus hospitals' choice of standard of care (SOC). In October, enrollment in the trial was halted after a DMC interim analysis of 394 patients met the pre-specified criterion for futility in regards to the primary endpoint (see BioCentury, Nov. 4, 2013). At the time, Valneva said it would discuss with the DMC reinitiating the trial with possible protocol modifications. However, the company said the trial would continue without modifications. Valneva could not be reached for additional details. ...