DiaMedica Starts Relaunched Phase 2/3 Trial for Acute Stroke Treatment

DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical firm dedicated to pioneering treatments for neurological disorders and cardio-renal disease, has disclosed the dosing of the first patient in its relaunched Phase 2/3 ReMEDy2 Trial of DM199 for acute ischemic stroke treatment.

The company is actively collaborating with its contract research organization (CRO) to reconnect with study sites for the ReMEDy2 Trial, aiming to enroll around 350 patients at up to 100 sites globally. Most U.S. sites are expected to be operational by the end of the third quarter of 2024, with Canadian site activation anticipated to commence in the same period, supported by the Canadian Stroke Consortium. In Australia, provisional endorsement from the Australian Stroke Trials Network (ASTN) has been obtained, with site activation projected to start in the fourth quarter of 2024. Initial efforts are underway to expand ReMEDy2 into the United Kingdom, Spain, and other select European countries.

Rick Pauls, DiaMedica’s President and CEO, expressed excitement about resuming enrollment, considering it a significant step forward in studying DM199’s potential as an ischemic stroke treatment. Lorianne Masuoka, DiaMedica’s Chief Medical Officer, noted the growing momentum in site activation, particularly in the U.S., and expressed optimism about the quality of activated and planned sites.

The ReMEDy2 trial employs an adaptive design, randomized, double-blind, placebo-controlled approach to investigate DM199’s efficacy in treating acute ischemic stroke (AIS) patients. Treatment duration is three weeks, commencing within 24 hours of AIS symptom onset, with final follow-up at 90 days. The trial excludes patients treated with tissue plasminogen activator (tPA) and/or mechanical thrombectomy. DiaMedica believes this trial could serve as a pivotal registration study for DM199 in this patient population.

DM199 is a synthetic form of human tissue kallikrein-1 (rKLK1), a serine protease enzyme crucial in regulating physiological processes by increasing nitric oxide and prostacyclin production. In ischemic stroke, DM199 administration aims to enhance blood flow to the infarction site, promote neuronal survival, inhibit neuronal cell death, and facilitate neuronal remodeling. KLK1 deficiency may contribute to various vascular and fibrotic diseases where current treatments are inadequate. DiaMedica is pioneering the development and clinical study of rKLK1. DM199 received Fast Track Designation from the FDA in September 2021 for AIS treatment.

DiaMedica Therapeutics Inc. is committed to advancing DM199 as a treatment for acute ischemic stroke and other serious diseases.

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