The ReMEDy2 Trial is an adaptive design, randomized, double-blind, placebo-controlled Phase 2/3 adaptive trial intended 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 whose ASPECT score <5 or infarct size >3cm. The study population is representative of the approximately 80% of AIS patients who do not have therapeutic treatment options today, primarily due to the short treatment window required for administration of Alteplase® (tPA) and who are not eligible for mechanical thrombectomy.
The primary endpoint in the ReMEDy2 trial is physical recovery from stroke as measured by the well-established modified Rankin Scale (mRS) at 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 mRS shift (which shows the treatment effect on participants across the full spectrum of stroke severity), participant deaths, additional standard stroke scores (NIHSS and Barthel Index scores). There is also be a sub-study evaluating the rate of stroke recurrence.LEARN MORE ABOUT ReMEDy2