DiaMedica Therapeutics Says FDA Lifts Clinical Hold On DM199 Phase 2/3 Trial For Ischemic Stroke
(RTTNews) - Biopharmaceutical company DiaMedica Therapeutics Inc. (DMAC) announced Wednesday that the U.S. Food and Drug Administration (FDA) has removed the clinical hold placed on the investigational new drug application for its ReMEDy2 phase 2/3 clinical trial studying DM199 in the treatment of acute ischemic stroke (AIS).
The company said preparations are underway to resume the ReMEDy2 trial as soon as possible.
The ReMEDy2 trial is an adaptive design, randomized, double-blind, placebo-controlled trial studying the use of the Company's product candidate, DM199, to treat acute ischemic stroke (AIS) patients.
The trial is intended to enroll approximately 350 patients at 75 sites in the United States. Patients enrolled in the trial will be treated for three weeks with either DM199 or placebo, beginning within 24 hours of the onset of AIS symptoms, with the final follow-up at 90 days.
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