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DiaMedica Therapeutics Initiates Pivotal Trial of DM199 for the Treatment of Acute Ischemic Stroke
The ReMEDy2 Trial Will Assess the Potential of DM199 to Both Improve Recovery After a Stroke and Prevent Stroke Recurrence Opportunity to Expand Therapeutic
About this update from Diamedica Therapeutics Inc.
[{"type":"text","content":"\n\n The ReMEDy2 Trial Will Assess the Potential of DM199 to Both Improve Recovery After a Stroke and Prevent Stroke Recurrence \n\n\nOpportunity to Expand Therapeutic Treatment Window and Eligible Patient Population for Acute Ischemic Stroke for the First Time in Decades \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, today announced the initiation of the first site for its pivotal ReMEDy2 Trial, a Phase 2/3 clinical study of DM199 for the treatment of acute ischemic stroke (AIS).\n\nThe ReMEDy2 Trial is a randomized, double-blind, placebo-controlled Phase 2/3 adaptive trial designed to enroll 350 patients at 75 sites in the United States. Patients enrolled in the study will be treated with either DM199 or placebo within 24 hours of the onset of AIS symptoms. The study excludes patients treated with tissue plasminogen activator (tPA) and those with large vessel occlusions. The study population is representative of the 80% of AIS patients who do not have treatment options today, primarily due to the short treatment window of 4.5 hours required for administration of tPA.\n\nThe ReMEDy2 trial has two primary endpoints and is powered for success with either endpoint: 1) recovery from stroke as measured by the well-established modified Rankin Scale (mRS) at day 90, and 2) the rate of ischemic stroke recurrence at day 30. Recurrent strokes represent 25% of all ischemic strokes, often occur in the first few weeks after an initial stroke and are typically more disabling, costly, and fatal than initial strokes. Secondary endpoints for the study will evaluate participant deaths, mRS shift (which shows the treatment effect on participants across the full spectrum of stroke severity) and additional standard stroke scores (NIHSS and Barthel Index scores).\n\n“Our investigators are enthusiastic to study a promising new therapy for their patients with the flexibility of a 24-hour treatment window, particularly given the challenges in emergency medicine today,” said Rick Pauls, DiaMedica’s Chief Executive Officer. “By either or both improving overall recovery and reducing the risk of a recurrent stroke, DM199 could be the first new therapeutic in 25 years that could meaningfully ch...