DiaMedica Commences Re-Launched DM199 Phase 2/3 Trial for Stroke Treatment

DiaMedica Therapeutics, a biopharmaceutical firm dedicated to developing therapies for neurological and cardio-renal conditions, has initiated dosing in its re-launched Phase 2/3 ReMEDy2 Trial. This pivotal study focuses on DM199, a potential treatment for acute ischemic stroke. The trial is set to enroll around 350 patients across approximately 100 global sites, with the majority of U.S. sites expected to be operational by the third quarter of 2024.

The ReMEDy2 Trial is an adaptive, randomized, double-blind, placebo-controlled study that will treat patients for three weeks with either DM199 or a placebo, starting within 24 hours of the onset of AIS symptoms. The final follow-up will be conducted at 90 days. The trial excludes patients who have received tissue plasminogen activator (tPA) and/or mechanical thrombectomy.

DM199 is a recombinant form of human tissue kallikrein-1 (rKLK1), an enzyme that regulates various physiological processes. It is designed to improve blood flow to the affected area in ischemic stroke patients and enhance neuronal survival. The drug candidate has received Fast Track Designation from the FDA for the treatment of acute ischemic stroke.

Rick Pauls, President and CEO of DiaMedica, expressed excitement about resuming enrollment, highlighting it as a significant step in the study of DM199. Lorianne Masuoka, the company's Chief Medical Officer, anticipates a substantial increase in U.S. site activations within the next six months and is encouraged by the quality of the sites already activated.

DiaMedica Therapeutics Inc. is a clinical-stage company with a mission to improve the lives of those suffering from serious diseases, particularly acute ischemic stroke. Their lead candidate, DM199, represents a novel approach to treating vascular diseases where current options are limited.