D-Pharm Receives FDA Approval For Acute Stroke Drug

D-Pharm announced that it has received FDA approval for its Investigational New Drug (IND) application for a pivotal Phase III clinical trial of DP-b99 in acute ischemic stroke patients.

The forthcoming Phase III trial is a randomized, double blind, placebo-controlled study. It is designed to compare the effect on ischemic stroke outcome between a placebo group and a group of patients treated with 1 mg/kg/day of DP-b99 for 4 consecutive days. D-Pharm plans to enroll 770 moderate to severely affected ischemic stroke patients worldwide, with first patients expected to be recruited in Israel and South Africa.

Gilad Rosenberg, VP Clinical Development at D-Pharm, said: The FDA’s IND procedure involved review of the entire DP-b99 data set. Following 30 days for review of our IND application, the FDA has no further questions relating to DP-b99’s CMC, preclinical and clinical data package. I’m very pleased that the Agency is satisfied with our data and we can move forward with this important study without delay.