DiaMedica Therapeutics Announces Fast Track Designation Granted To DM199 For The Treatment Of Acute Ischemic Stroke
DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, today announced that the U.S. Food & Drug Administration (FDA) has granted Fast Track Designation to the Company’s lead candidate DM199 for the treatment of acute ischemic stroke (AIS) where tissue plasminogen activator and/or mechanical thrombectomy are not indicated or medically appropriate.
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.
“Receipt of Fast Track designation from the FDA underscores the significant unmet medical need among patients suffering from acute ischemic stroke, an area where there hasn’t been a new therapeutic that could meaningfully change outcomes for stroke patients in 25 years,” said Rick Pauls, DiaMedica’s Chief Executive Officer. “The FDA Fast Track Designation is an important milestone in the development of DM199, as it provides opportunities to engage collaboratively with the FDA to further the clinical development and future regulatory review of DM199 for the treatment of acute ischemic stroke. We look forward to working with the FDA to bring DM199 to market as quickly as possible.”
About DM199
DM199 is a recombinant (synthetic) form of human tissue kallikrein-1 (KLK1). 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.
About DiaMedica Therapeutics Inc.
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. For more information visit our website at www.diamedica.com.
September 30, 2021
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