DiaMedica Therapeutics, Inc.

For Physicians

About ReMEDy2

The ReMEDy2 trial is an adaptive design, randomized, double-blind, placebo-controlled Phase 2/3 trial intended to enroll approximately 300 acute ischemic stroke (AIS) patients at up to 100 sites globally. The final sample size will be determined based upon the results of an interim analysis of 200 participants. 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 who responded to a thrombolytic, received or are eligible to receive mechanical thrombectomy, and those with occlusions in the intracranial carotid artery or M1 segment of the middle cerebral vertebral or basilary arteries, or large vessel occlusions, or 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) of 0-1 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).

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About DM199

DM199 (rhKLK1) is a recombinant (synthetic) form of the naturally occurring protein called 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 (NO), prostacyclin (PGI2), and endothelium-derived hyperpolarizing factor (EDHF). KLK1 deficiency has been reported to play a role in multiple vascular and fibrotic diseases such as stroke, hypertension, preeclampsia, 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 ischemic diseases with a focus on preeclampsia, fetal growth restriction and acute ischemic stroke. 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, preeclampsia and other vascular diseases.

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