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DiaMedica Therapeutics Announces FDA Clearance of IND Application to Initiate Phase 2/3 Clinical Trial for DM199 for Acute Ischemic Stroke
Initiating ReMEDy2 – Pivotal Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study MINNEAPOLIS--(BUSINESS WIRE)-- DiaMedica Therapeutics Inc. (Nasdaq:
About this update from Diamedica Therapeutics Inc.
[{"type":"text","content":"\n\nInitiating ReMEDy2 – Pivotal Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study\n\n\n MINNEAPOLIS--(BUSINESS WIRE)--\nDiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical Company focused on developing novel treatments for neurological disorders and kidney diseases, announced today that the U.S. Food & Drug Administration (FDA) has accepted the Company’s Investigational New Drug (IND) application. The Company plans to proceed with a pivotal Phase 2/3 study of DM199 (recombinant human tissue kallikrein-1or KLK1) for the treatment of patients with Acute Ischemic Stroke (AIS).\n\nThe upcoming ReMEDy2 Trial follows the Phase 2 study in AIS patients that demonstrated an improvement in stroke outcomes and reduction in stroke recurrence, along with an excellent safety profile. The findings are consistent with a significant body of clinical evidence from the use of the approved urinary-sourced KLK1 (Kailikang®) in China. The upcoming pivotal ReMEDy2 trial will evaluate whether DM199, a recombinant investigational agent, can improve three-month outcomes in AIS patients without other treatment options.\n\n“While we have options to remove or dissolve clots in a small segment of AIS patients, we need novel treatment options for the remaining 80% of stroke patients who often have clinically significant morbidity and mortality following an acute ischemic stroke,” said Scott Kasner, M.D., Professor of Neurology and Director of Comprehensive Stroke Center at the University of Pennsylvania. “In the ReMEDy2 Trial, we will be evaluating a mechanism of action with significant rationale and clinical data supporting the hypothesis that restoring low KLK1 levels with DM199 may both improve patient outcomes following a stroke and reduce the number of recurrent strokes.”\n\nThe ReMEDy2 Trial is a randomized, double-blind, placebo-controlled Phase 2/3 trial with the objective to enroll approximately 350 participants at up to 75 sites. Adult participants must be able to initiate treatment, DM199 or placebo, within 24 hours of AIS onset and who do not have a large vessel occlusion (e.g. patients eligible for mechanical thrombectomy) and/or who do not receive tissue plasminogen activator (tPA). This patient group represents up to 80% of the approximately 700,000 patients who experience an AIS each year in the United St...