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DiaMedica Therapeutics Announces Addition of Stroke Recurrence as a Second Independent Primary Endpoint in ReMEDy2 Phase 2/3 AIS Trial
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 accepted and concluded that DiaMedica “may proceed” with the proposed clinical investigation using its amended protocol adding stroke recurrence as a second independent primary endpoint to its Phase 2/3 ReMEDy2 trial evaluating DM199 for acute ischemic stroke (AIS). The FDA’s acceptance of the amendment allows the Company to evaluate the effects of DM199 on both physical recoveries post AIS and the rate of recurrent AIS, as two separate independent primary endpoints, with each statistically powered for success. There are no changes in treatment, duration, or study population of the trial as part of this protocol amendment.\n\nReMEDy2 is a Phase 2/3 adaptive design, randomized, double-blind, placebo-controlled trial to evaluate the safety and efficacy of DM199 for the treatment of AIS, now addressing both stroke recovery and stroke recurrence. The trial is studying AIS in a patient population for whom thrombolysis and/or a catheter-based procedure, mechanical thrombectomy, are not medically appropriate or available due to constraints of clot location, comorbidity risks or time from estimated onset of stroke, which represents approximately 80% of all AIS patients. Stroke recovery is defined as patients with excellent functional outcomes at Day 90 as assessed via the modified Rankin Scale (mRS) with scores of 0 or 1, on a scale from 0-6. Recurrent AIS will be evaluated based upon the proportion of patients who experience a recurrent AIS by Day 90.\n\nApproximately 25% of the 795,000 acute ischemic strokes that occur each year in the U.S. are recurrent. The rationale for adding stroke recurrence to the ReMEDy2 trial as an independent primary endpoint is based on data obtained from DiaMedica’s prior ReMEDy Phase 2 study in AIS. In that study, 45 patients received placebo and 46 were treated with DM199. During the 90-day follow-up period, recurrent ischemic stroke occurred in 6 patients (13.3%) of the placebo arm versus none in the DM199 arm (P=0.012). Moreover, 4 (66%) of the recorded strokes in the placebo arm were fatal. When excluding patients pre-treated with...