First Patient Receives DM199 in Restarted ReMEDy2 Trial for Acute Ischemic Stroke

DiaMedica Therapeutics, a biopharmaceutical firm dedicated to developing innovative treatments for neurological conditions and cardio-renal diseases, has initiated a pivotal Phase 2/3 clinical trial for DM199, a drug intended for acute ischemic stroke patients. The ReMEDy2 Trial is set to include around 350 participants across nearly 100 global sites. The majority of U.S. locations are projected to be operational by the third quarter of 2024, with Canadian sites expected to follow suit in the same period, thanks to the support of the Canadian Stroke Consortium. Additionally, provisional endorsement from the Australian Stroke Trials Network has been received, with plans for Australian site activation to begin in the fourth quarter of 2024. Efforts are also underway to extend the trial to the United Kingdom, Spain, and other European nations.

Rick Pauls, President and CEO of DiaMedica, expressed excitement about the trial's resumption, highlighting its significance in advancing the study of DM199 as a potential ischemic stroke treatment. Lorianne Masuoka, the company's Chief Medical Officer, anticipates a notable increase in U.S. site activations over the next six months and is encouraged by the quality of the already activated sites, which have a history of high enrollment in stroke research.

The ReMEDy2 Trial is designed to be adaptive, randomized, double-blind, and placebo-controlled, focusing on the efficacy of DM199 in treating AIS patients. Participants will receive either the drug or a placebo for three weeks, starting within 24 hours of symptom onset, with a final follow-up at 90 days. The trial specifically excludes patients who have undergone treatment with tissue plasminogen activator (tPA) or mechanical thrombectomy. DiaMedica is hopeful that the trial will serve as a key registration study for DM199 in this patient group.

DM199 is a synthetic version of human tissue kallikrein-1 (rKLK1), an enzyme that plays a crucial role in various physiological processes. It is identical to naturally produced KLK1 and works by increasing the production of nitric oxide and prostacyclin, which can enhance blood flow to the affected area in ischemic stroke cases and promote neuronal survival. The drug also inhibits apoptosis and facilitates neuronal remodeling through angiogenesis. KLK1 deficiency has been linked to several vascular and fibrotic diseases where current treatments are limited or ineffective. DiaMedica is pioneering the development and clinical study of rKLK1, with non-recombinant KLK1 already approved for use in Japan, China, and South Korea for various ischemic conditions.

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, is the first synthetic form of the KLK1 protein, which has been established as a therapeutic modality in Asia for treating AIS and other vascular diseases. In September 2021, the FDA granted Fast Track Designation to DM199 for AIS treatment.