DiaMedica Initiates Pivotal Trial Of DM199 For Treatment Of Acute Ischemic Stroke

DiaMedica Therapeutics Inc. (DMAC) announced the initiation of the first site for its pivotal ReMEDy2 Trial, a Phase 2/3 clinical study of DM199 for the treatment of acute ischemic stroke or AIS.

The ReMEDy2 trial will assess the potential of DM199 to both improve recovery after a stroke and prevent stroke recurrence.

"By either or both improving overall recovery and reducing the risk of a recurrent stroke, DM199 could be the first new therapeutic in 25 years that could meaningfully change outcomes for stroke patients. Stroke represents a significant, unmet medical need for approximately 700,000 patients annually in the U.S. and millions more globally," said Rick Pauls, DiaMedica's Chief Executive Officer.

The ReMEDy2 Trial is a randomized, double-blind, placebo-controlled Phase 2/3 adaptive trial designed to enroll 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 AIS symptoms. The study excludes patients treated with tissue plasminogen activator (tPA) and those with large vessel occlusions.

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