DiaMedica Therapeutics Announces First Patient Dosed in Relaunch of its Pivotal Phase 2/3 ReMEDy2 Trial of DM199 for the Treatment of Acute Ischemic Stroke

DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and cardio-renal disease, today announced the first patient being dosed in DiaMedica’s relaunch of its pivotal Phase 2/3 ReMEDy2 Trial of DM199 for the treatment of acute ischemic stroke.

The company continues to work closely with its contract research organization (CRO), on re-engaging with study sites for the ReMEDy2 Trial. The trial is intended to enroll approximately 350 patients at up to 100 sites globally. The majority of the U.S. sites are expected to be activated by the end of the third quarter of 2024. With the support of the Canadian Stroke Consortium, the activation of study sites in Canada is expected to begin in the third quarter of 2024. In Australia, the Company has received provisional endorsement from the Australian Stroke Trials Network (ASTN) and Australian site activation is expected to commence in the fourth quarter of 2024. Initial steps are also being taken to expand ReMEDy2 into the United Kingdom, Spain, and select other European countries.

“We are thrilled to resume enrollment as this marks a major milestone towards continuing our study of DM199 as a potential treatment for ischemic stroke patients,” commented Rick Pauls, DiaMedica’s President and Chief Executive Officer.

“Site activation momentum continues to build, and we anticipate a significant ramp-up in the United States over the next six months," commented Lorianne Masuoka, DiaMedica’s Chief Medical Officer. "Furthermore, we are highly encouraged by the quality of the sites we have already activated and those planned for activation in the coming months. These sites have historically been high enrollers in stroke studies.”

About ReMEDy2 Trial

The ReMEDy2 trial is an adaptive design, randomized, double-blind, placebo-controlled trial studying the use of the Company’s product candidate, DM199, to treat acute ischemic stroke (AIS) patients. Patients enrolled in the trial will be treated for three weeks with either DM199 or placebo, beginning within 24 hours of the onset of AIS symptoms, with the final follow-up at 90 days. The trial excludes patients treated with tissue plasminogen activator (tPA) and/or mechanical thrombectomy. DiaMedica believes that the proposed trial has the potential to serve as a pivotal registration study of DM199 in this patient population.