D-Pharm Ltd., has received Fast Track designation by the US Food and Drug Administration (FDA) for its DP-b99 development programme for treatment of moderately severe stroke patients. DP-b99 is currently being tested in a pivotal international phase III trial, MACSI.
The FDA Fast Track development program is a designation that accelerates the approval in the US of investigational new drugs undergoing clinical trials. It is specifically designed to facilitate the development, and expedite the review of drugs to treat serious diseases and fill an unmet medical need. The Fast Track will allow D-Pharm to submit parts of its request for a New Drug Approval (NDA) as these parts become available, without having to wait and submit all parts of the application together, as usually required by the FDA. Alex Kozak, D-Pharm’s CEO commented, “This Fast Track designation to expedite the progress of DP-b99 to market is an important vote of confidence in D-Pharm and we look forward to the frequent and fruitful interactions with the agency encouraged by this designation.”
The Membrane Activated Chelator Stroke Intervention (MACSI) 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. The MACSI study is enrolling 770 patients, with recruitment ongoing at over 100 clinical sites in North America, Europe, South America, South Africa and Israel. In April 2010 the protocol for the trial was agreed with the US FDA under the Special Protocol Assessment (SPA) procedure.
DP-b99 is a unique broad-spectrum neuroprotective drug that addresses an array of brain damaging processes occurring in stroke patients. Both preclinical and clinical phase I and II studies indicate a favourable efficacy and safety profile for DP-b99. In the phase II b trial in 150 ischemic stroke patients, DP-b99 increased by two-fold the percentage of patients that recovered from ischemic stroke. DP-b99 may be administered within a nine hour therapeutic window.
Every year around 1.5 million people in the US, Western Europe and Japan suffer an acute stroke. Stroke is a leading cause of death in the western world and around 50% of stroke survivors suffer from some form of severe disability. According to the American Heart Association (AHA) the annual economic burden of stroke in the US was around $70B in 2009. Currently, between 2-5% of stroke patients receive tissue Plasminogen Activator (tPA), the only drug currently approved for treatment of acute stroke in the US.
D-Pharm is a clinical stage, biopharmaceutical company pioneering the development of lipid-like therapeutics, and has generated a rich pipeline of patent protected proprietary products.