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Phase 2/3 Adaptive Design, Randomized Double-blind Placebo-controlled Study to Evaluate the Safety, and Efficacy of DM199 for the Treatment of Acute Ischemic Stroke (ReMEDy 2 Trial)

The objective of this study is to evaluate the safety, and efficacy of DM199 in treating patients presenting with Acute Ischemic Stroke (AIS) - evaluating rates of both Recovery and Recurrent AIS for whom thrombolysis and/or catheter-based procedure, mechanical thrombectomy (MT), are not medically appropriate or available due to constraints of clot location, comorbidity risks, and/or time from estimated onset of AIS. Patients considered for this trial should not be denied the use of standard of care (SoC) AIS therapies such as thrombolysis or MT when appropriate and should not be screened for study. Patients who present with a large vessel occlusion will be excluded from study, regardless of whether MT or thrombolysis is used.

The objective of this study is to evaluate the safety, and efficacy of DM199 in treating patients presenting with Acute Ischemic Stroke (AIS) - evaluating rates of both Recovery and Recurrent AIS for whom thrombolysis and/or catheter-based procedure, mechanical thrombectomy (MT), are not medically appropriate or available due to constraints of clot location, comorbidity risks, and/or time from estimated onset of AIS. Patients considered for this trial should not be denied the use of standard of care (SoC) AIS therapies such as thrombolysis or MT when appropriate and should not be screened for study. Patients who present with a large vessel occlusion will be excluded from study, regardless of whether MT or thrombolysis is used.