The ReMEDy2 Trial is a randomized, double-blind, placebo-controlled Phase 2/3 adaptive trial designed to enroll approximately 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 their AIS symptoms. The study excludes patients treated with a thrombolytic or mechanical thrombectomy and those with large vessel occlusions. The study population is representative of the approximately 80% of AIS patients who do not have treatment options today, primarily due to the short approved treatment window of three (3) hours required for administration of Alteplase® (tPA).
DiaMedica intends to evaluate two primary endpoints in the ReMEDy2 trial and is powered for success with either endpoint: 1) physical recovery from stroke as measured by the well-established modified Rankin Scale (mRS) at day 90 and 2) the rate of ischemic stroke recurrence as of day 90. Strokes are the leading cause of adult disability and a leading cause of death in the United States. Recurrent strokes, representing approximately 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).LEARN MORE ABOUT ReMEDy2