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DiaMedica Announces Positive Results in Top-Line Data From the Phase II ReMEDy Acute Ischemic Stroke Study
DM199 Met Primary Safety and Tolerability Endpoints in ReMEDy Study Top-Line Data Demonstrated Therapeutic Effect in Participants Not Pre-Treated With
About this update from Diamedica Therapeutics Inc.
[{"type":"text","content":"\n\nDM199 Met Primary Safety and Tolerability Endpoints in ReMEDy Study Top-Line Data\n\n\nDemonstrated Therapeutic Effect in Participants Not Pre-Treated With Mechanical Thrombectomy\n\n\nReduced Risk of Recurrent Stroke\n\n\nResults Consistent With Clinical Studies of Approved Urinary Derived KLK1 in China\n\n\nImprovement in eGFR for Pre-Defined Chronic Kidney Disease Sub-Group\n\n\n\nCompany to discuss top-line data during its scheduled first quarter financial results conference call tomorrow at 8:00 am Eastern Time\n\n MINNEAPOLIS--(BUSINESS WIRE)--\nDiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company developing novel treatments for neurological disorders and chronic kidney disease, announced today that DM199, a drug intended to restore KLK1 levels and the body’s natural ability to regulate blood flow and reduce inflammation after an acute ischemic stroke (AIS), met primary safety and tolerability endpoints in the ReMEDy phase II study. Further, no DM199-related serious adverse events were noted in the study. According to top-line phase II results, there was also a demonstrated therapeutic effect in participants who received tissue plasminogen activator (tPA) prior to enrollment, but not in participants receiving mechanical thrombectomy.\n\n\nThe ReMEDy study enrolled 92 participants to assess DM199, a recombinant form of human tissue Kalikrein-1 (KLK1), a serine protease, or protein, which plays a critical role in local blood flow regulation and in reducing inflammation, in the treatment of participants who experienced an AIS. AIS occurs when a clot blocks blood flow through a brain artery and represents approximately 85% of all strokes in the United States. According to the U.S. Centers for Disease Control and Prevention (CDC), there are approximately 690,000 acute ischemic strokes in the United States annually, one quarter of which are recurrent strokes, or strokes occurring in people who have had a previous stroke.\n\n\nNinety-one (91) of the 92 ReMEDy study enrolled participants were evaluable for safety in this multi-center, double-blind, randomized, placebo-controlled study. Participants were enrolled within 24 hours of stroke symptom onset and received an initial administration of DM199 or placebo as an intravenous infusion, followed by subcutaneous injections every three days over...