DP-b99: Development discontinued

D-Pharm discontinued development of DP-b99 to treat stroke after an interim analysis of the double-blind, placebo-controlled, international Phase III MACSI trial showed that the compound met undisclosed criteria for futility. No safety concerns were identified. The trial was evaluating 1 mg/kg/day IV DP-b99 for 4 consecutive days initiated up to 9 hours following acute ischemic stroke onset. The trial, which had an SPA from FDA, was slated to enroll 770 patients. Last year, a DSMB recommended continuation of the MACSI trial based on safety data from the first 200 patients who completed follow-up (see BioCentury, July 25, 2011). ...