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DiaMedica Therapeutics Announces 75% Enrollment Milestone in ReMEDy2 Phase 2/3 Acute Ischemic Stroke Trial
DiaMedica Therapeutics Announces 75% Enrollment Milestone in ReMEDy2 Phase 2/3 Acute Ischemic Stroke
About this update from Diamedica Therapeutics Inc.
[{"type":"text","content":"\nDiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for acute ischemic stroke, preeclampsia and fetal growth restriction, today announced that enrollment in its pivotal Phase 2/3 ReMEDy2 trial of DM199 (rinvecalinase alfa) in patients with acute ischemic stroke (AIS) has reached 75% of the 200-patient threshold required to trigger the planned interim analysis. The Company reiterates its guidance regarding completion of the interim analysis by the end of 2026.\n\n\nThe interim analysis will be conducted by the independent Data Safety Monitoring Board (DSMB) and is planned to determine if a sample size re-estimation is recommended for the ReMEDy2 trial. The interim analysis is intended to ensure the trial is adequately powered for success and preserves the trial’s integrity. The Company will be blinded to the specific results of the interim analysis.\n\n\nThe ReMEDy2 trial (NCT05065216) is an adaptive, randomized, double-blind, placebo-controlled Phase 2/3 study evaluating DM199 in patients with AIS. The primary efficacy endpoint is stroke recovery as defined by the proportion of patients with a modified Rankin Score (mRS) of 0 or 1 (0-to-6-point scale) at Day 90 indicating an excellent clinical outcome. The trial protocol includes a pre-specified interim analysis on the first 200 enrolled participants, at which point the DSMB will assess whether to recommend a sample size re-estimation to optimize the trial’s statistical power or stopping for futility. The final sample size, to be determined following the interim analysis, will range between 300 and 728 patients. Patient recruitment will continue at active clinical sites while the first 200 participants complete their follow-up and the interim analysis is conducted.\n\n\n“Reaching 75% enrollment toward our interim analysis threshold is a meaningful milestone that reflects the dedication of our clinical sites and the urgency of finding new treatments for stroke patients,” said Dr. Julie Krop, Chief Medical Officer of DiaMedica Therapeutics. “We now have approximately 70 sites activated. Based on projected enrollment rates across our network of centers in the United States, Canada, the United Kingdom and Europe, we anticipate completing the interim analysis before year-end. This analysis will be an importan...