For Physicians

About ReMEDy2

The ReMEDy2 Trial is an adaptive design, randomized, double-blind, placebo-controlled Phase 2/3 adaptive trial intended to enroll approximately 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 their AIS symptoms. The study excludes patients treated with a thrombolytic or mechanical thrombectomy and those with large vessel occlusions whose ASPECT score <5 or infarct size >3cm. The study population is representative of the approximately 80% of AIS patients who do not have therapeutic treatment options today, primarily due to the short treatment window required for administration of Alteplase^® (tPA) and who are not eligible for mechanical thrombectomy.

The primary endpoint in the ReMEDy2 trial is physical recovery from stroke as measured by the well-established modified Rankin Scale (mRS) at day 90. Strokes are the leading cause of adult disability and a leading cause of death in the United States. Recurrent strokes, representing approximately 25% of all ischemic strokes, often occur in the first few weeks after an initial stroke and are typically more disabling, costly and fatal than initial strokes. Secondary endpoints for the study will evaluate mRS shift (which shows the treatment effect on participants across the full spectrum of stroke severity), participant deaths, additional standard stroke scores (NIHSS and Barthel Index scores). There is also be a sub-study evaluating the rate of stroke recurrence.

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About DM199

DM199 is a recombinant (synthetic) form of the human tissue kallikrein-1 (KLK1) protein. KLK1 is a serine protease (protein) that plays an important role in the regulation of diverse physiological processes including blood flow, inflammation, fibrosis, oxidative stress and neurogenesis via a molecular mechanism that increases production of nitric oxide and prostaglandin. KLK1 deficiency may play a role in multiple vascular and fibrotic diseases such as stroke, hypertension, chronic kidney disease, retinopathy, vascular dementia, and resistant hypertension where current treatment options are limited or ineffective. DiaMedica is the first company to have developed and clinically studied a recombinant form of the KLK1 protein. The KLK1 protein, produced from the pancreas of pigs and human urine, has been used to treat patients in Japan, China and South Korea for decades. DM199 is currently being studied in patients with acute ischemic stroke (AIS). In September 2021, the FDA granted Fast Track Designation to DM199 for the treatment of AIS.

About DiaMedica

DiaMedica Therapeutics Inc. is a clinical stage biopharmaceutical company committed to improving the lives of people suffering from serious diseases. DiaMedica’s lead candidate DM199 is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, an established therapeutic modality in Asia for the treatment of acute ischemic stroke and chronic kidney disease. Based on promising early clinical results, DiaMedica has initiated and commenced enrollment in its ReMEDy2 Phase 2/3 trial in the treatment of AIS.

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The safety and effectiveness of DM199 for the treatment of acute ischemic stroke or cardio-renal disease has not been established and is limited to investigational use only.