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DiaMedica Therapeutics Announces that the FDA Has Removed The Clinical Hold On DM199 Phase 2/3 Trial For Ischemic Stroke
MINNEAPOLIS--(BUSINESS WIRE)-- DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments
About this update from Diamedica Therapeutics Inc.
[{"type":"text","content":" 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 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) and that preparations are underway to resume the ReMEDy2 trial as soon as possible.\n\n\n“We are pleased that the FDA has fully lifted the clinical hold. DM199, a synthetic formulation of the human tissue-1 kallikrein protein (KLK1), represents a novel approach to treating AIS patients, principally aimed at enhancing collateral blood flow in the brain tissues affected by the stroke,” said Rick Pauls, DiaMedica’s President and CEO.\n\n\n“We look forward to re-engaging with our study sites and stroke expert principal investigators as we resume our ReMEDy2 trial as there is continued unmet need of new potential therapeutics for patients who have had an ischemic stroke,” said Kirsten Gruis, MD, DiaMedica’s Chief Medical Officer.\n\n\nAbout the ReMEDy2 Trial\n\n\nThe 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. The trial excludes patients treated with tissue plasminogen activator (tPA) and/or mechanical thrombectomy. The study population is representative of the approximately 80% of AIS patients who do not have treatment options today, primarily due to the limitations on treatment with tPA or mechanical thrombectomy. DiaMedica believes that the proposed trial has the potential to serve as a pivotal registration study of DM199 in this patient population.\n\n\nAbout DM199\n\n\nDM199 is a recombinant (synthetic) form of human tissue kallikrein-1 (KLK1). KLK1 is a serine protease (protein) that plays an important role in the regulation of diverse physiological proces...