30 September 2021 - - The US Food and Drug Administration has granted Fast Track Designation to US-based clinical-stage biopharmaceutical company DiaMedica Therapeutics Inc's (NASDAQ: DMAC) lead candidate DM199 for the treatment of acute ischemic stroke where tissue plasminogen activator and/or mechanical thrombectomy are not indicated or medically appropriate, the company said.

Fast Track is a process intended to facilitate the development and expedite the review of investigational drugs for the treatment of serious or life-threatening conditions where there is an unmet medical need.

Drugs that receive Fast Track designation may be eligible for more frequent communications and meetings with FDA to review the drug's development plan, including the design of the proposed clinical trials, use of biomarkers and the extent of data needed for approval.

Drugs with Fast Track Designation may also qualify for accelerated and priority review of new drug applications if relevant criteria are met.

DM199 is a recombinant (synthetic) form of human tissue kallikrein-1.

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, among other things, increases production of nitric oxide and prostaglandin.

KLK1 deficiency may play a role in multiple vascular and fibrotic diseases such as stroke, 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 pharmaceutically active recombinant form of the KLK1 protein.

The KLK1 protein, in forms produced from porcine pancreas and human urine, has been used to treat patients in Japan, China and Korea for decades.

DM199 is currently being studied in patients with acute ischemic stroke and chronic kidney disease.

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 for the treatment of acute ischemic stroke and chronic kidney disease.