D-Pharm Ltd has reached an agreement with the US Food and Drug Administration (FDA) under the Special Protocol Assessment (SPA) procedure for a pivotal phase 3 trial (MACSI) of its neuroprotective agent DP-b99 in acute ischemic stroke patients. The SPA agreement letter indicates that “the design and planned analysis of the study adequately address the objectives necessary to support a regulatory submission” of the drug for marketing approval, a New Drug Application (NDA).

Dr Gilad Rosenberg, D-Pharm’s VP Clinical Development commented: “The FDA thoroughly reviewed this protocol and issued an SPA agreement letter – the same FDA that will have to eventually rule whether DP-b99 may receive marketing authorization in the USA. Their agreement to the protocol attests to the adequacy of the MACSI trial design, and confirms that the MACSI results, if positive, will be able to support a New Drug Application submission. As such, the SPA agreement represents an auspicious development of major significance.”

The MACSI trial is a double blind, randomized, placebo controlled, parallel group, multicenter and multinational phase 3 pivotal study to compare, using mRS “Shift Analysis” at Day 90, the therapeutic effects of 1mg/kg/day intravenous DP-b99 over 4 consecutive days versus placebo, in subjects with moderately severe, likely hemispheric, acute ischemic stroke. Treatment will be initiated within nine hours of acute ischemic stroke onset. The safety and tolerability of DP-b99 will be assessed, as well as post-stroke recovery according to mRS and NIHSS Day 90 scores.

The study will enroll 770 patients, with recruitment started at some of the 140 clinical sites in Europe, USA, Canada, Brazil, South Africa, Israel and South Korea.

Special Protocol Assessment (SPA) is an instrument of the FDA for evaluating protocols and reaching agreement with sponsors on the design of clinical trials that can be used for drug approval.

DP-b99, by virtue of its ability to modulate pathological levels of zinc in the vicinity of membranes, is a multi-targeted compound for the treatment of stroke that addresses an array of brain damaging processes occurring in stroke patients.

D-Pharm is a technology-driven biopharmaceutical company focused on the discovery and development of innovative proprietary drugs for the treatment of central nervous system disorders and cancer.