Abstract Number: Esoc2026ot84 Remedy2 Trial: A Phase 2/3 Adaptive, Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Safety and Efficacy of Rinvecalinse Alfa (Dm199) in Acute Ischemic Stroke

Abstract Background and aims Although intravenous thrombolysis (IVT) and endovascular thrombectomy (EVT) improve outcomes, many patients with ischemic stroke remain ineligible, lack access, or have persistent disability. Rinvecalinase alfa (DM199), recombinant human tissue kallikrein-1, may augment cerebral perfusion via bradykinin-mediated signaling and promote vascular repair, potentially improving outcomes and reducing stroke recurrence. Methods ReMEDy2 evaluates safety and efficacy of DM199 versus placebo in acute ischemic stroke. Results ReMEDy2 is a global, Phase 2/3 adaptive, randomized, double-blind, placebo-controlled trial. Adults presenting within 24 hours of stroke onset with National Institutes of Health Stroke Scale (NIHSS) scores of 5-15 are randomized 1:1 to DM199 or placebo, both receiving standard care. Patients with large vessel occlusion or early clinical improvement after IVT are excluded. Study intervention is a single intravenous dose followed by twice-weekly subcutaneous injections through Day 21. Conclusions The primary endpoint is excellent stroke recovery at 90 days (modified Rankin Scale mRS score of 0-1). Secondary outcomes include 90-day mRS shift, NIHSS, Barthel Index, recurrent stroke, mortality, and safety. Conflict of interest