DMAC - DiaMedica gets FDA clearance to initiate phase 2/3 acute ischemic stroke trial

DiaMedica Therapeutics (DMAC) announces that the U.S. FDA has accepted the company’s Investigational New Drug ((IND)) application for a Phase 2/3 trial in Acute Ischemic Stroke ((AIS)) patients.The company said that it plans to proceed with a pivotal Phase 2/3 study of DM199 (recombinant human tissue kallikrein-1or KLK1) for the treatment of patients with AIS.The trial is a randomized, double-blind, placebo-controlled trial with the objective to enroll about 350 participants at up to 75 sites.Participants will be randomized 1:1 to receive either DM199 or placebo and will be treated for 3 weeks with final follow up at day 90.Endpoints will include the modified Rankin Scale ((mRS)), stroke recurrence, the National Institute of Health Stroke Score ((NIHSS)) and Barthel Index, deaths, safety and tolerability.AIS is a serious medical emergency caused by sudden loss of blood flow to an area of the brain, resulting in localized damage to the brain, often causing disability or

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DiaMedica gets FDA clearance to initiate phase 2/3 acute ischemic stroke trial