For Physicians

About ReMEDy2

The ReMEDy2 Trial is a randomized, double-blind, placebo-controlled Phase 2/3 adaptive trial designed 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. The study population is representative of the approximately 80% of AIS patients who do not have treatment options today, primarily due to the short approved treatment window of three (3) hours required for administration of Alteplase^® (tPA).

DiaMedica intends to evaluate two primary endpoints in the ReMEDy2 trial and is powered for success with either endpoint: 1) physical recovery from stroke as measured by the well-established modified Rankin Scale (mRS) at day 90 and 2) the rate of ischemic stroke recurrence as of 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 participant deaths, mRS shift (which shows the treatment effect on participants across the full spectrum of stroke severity) and additional standard stroke scores (NIHSS and Barthel Index scores).

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About DM199

DM199 is a recombinant (synthetic) form of a naturally occurring protein called human tissue kallikrein-1 (KLK1). KLK1 is produced primarily in the kidneys, pancreas and salivary glands. KLK1, which is part of the kallikrein-kinin system, plays an important role in the regulation of local blood flow and vasodilation (the widening of blood vessels which decreases blood pressure) in the body, as well as an important role in mitigating inflammation and oxidative stress (an imbalance between potentially damaging reactive oxygen species, or free radicals, and antioxidants in the body). With age, the body’s ability to produce KLK1 may be reduced. KLK1 levels are often low in patients who have experienced a stroke and/or are at risk of a recurrent stroke. DiaMedica is the first company to have developed and clinically studied a pharmaceutically active recombinant form of the KLK1 protein. With KLK1 therapy, we believe that KLK1 levels and the natural function of the kallikrein-kinin system may be restored to enable the body’s natural ability to produce the required nitric oxide (NO) and prostaglandins (PG) and deliver them to where they are needed to fight harmful inflammation and repair injured blood vessels and to help patients recover from acute ischemic stroke and to reduce the risk of stroke recurrence. This is because the KLK1 protein sits on the top of the molecular pathway that drives the natural production of nitric oxide and prostaglandins. DM199 is currently being studied in patients with acute ischemic stroke and chronic kidney disease.

About DiaMedica

DiaMedica Therapeutics Inc. is a clinical stage biopharmaceutical company committed to improving the lives of people suffering serious diseases. Its lead candidate DM199 is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein. Based on promising early clinical results, DiaMedica has initiated and commenced enrollment in its ReMEDy2 Phase 2/3 trial in the treatment of AIS and is completing enrollment in its REDUX Phase 2 trial for the treatment of certain rare and significant unmet causes of CKD For more information visit our website at www.diamedica.com.

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