DiaMedica Therapeutics Announces FDA Clearance of IND Application to Initiate Phase 2/3 Clinical Trial for DM199 for Acute Ischemic Stroke
- Category: Proteins and Peptides
- Published on Tuesday, 18 May 2021 13:06
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- Initiating ReMEDy2 – Pivotal Phase 2/3 Randomized, Double-Blind, Placebo-Controlled Study
MINNEAPOLIS, MN, USA I May 17, 2021 I DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical Company focused on developing novel treatments for neurological disorders and kidney diseases, announced today that the U.S. Food & Drug Administration (FDA) has accepted the Company’s Investigational New Drug (IND) application. The Company plans to proceed with a pivotal Phase 2/3 study of DM199 (recombinant human tissue kallikrein-1or KLK1) for the treatment of patients with Acute Ischemic Stroke (AIS).
The upcoming ReMEDy2 Trial follows the Phase 2 study in AIS patients that demonstrated an improvement in stroke outcomes and reduction in stroke recurrence, along with an excellent safety profile. The findings are consistent with a significant body of clinical evidence from the use of the approved urinary-sourced KLK1 (Kailikang®) in China. The upcoming pivotal ReMEDy2 trial will evaluate whether DM199, a recombinant investigational agent, can improve three-month outcomes in AIS patients without other treatment options.
“While we have options to remove or dissolve clots in a small segment of AIS patients, we need novel treatment options for the remaining 80% of stroke patients who often have clinically significant morbidity and mortality following an acute ischemic stroke,” said Scott Kasner, M.D., Professor of Neurology and Director of Comprehensive Stroke Center at the University of Pennsylvania. “In the ReMEDy2 Trial, we will be evaluating a mechanism of action with significant rationale and clinical data supporting the hypothesis that restoring low KLK1 levels with DM199 may both improve patient outcomes following a stroke and reduce the number of recurrent strokes.”
The ReMEDy2 Trial is a randomized, double-blind, placebo-controlled Phase 2/3 trial with the objective to enroll approximately 350 participants at up to 75 sites. Adult participants must be able to initiate treatment, DM199 or placebo, within 24 hours of AIS onset and who do not have a large vessel occlusion (e.g. patients eligible for mechanical thrombectomy) and/or who do not receive tissue plasminogen activator (tPA). This patient group represents up to 80% of the approximately 700,000 patients who experience an AIS each year in the United States. Participants will be randomized 1:1 to receive either DM199 or placebo and will be treated for 3 weeks with final follow up at day 90. Endpoints will include the modified Rankin Scale (mRS), stroke recurrence, the National Institute of Health Stroke Score (NIHSS) and Barthel Index, deaths, safety and tolerability. The Company plans an interim analysis to determine whether (i) the study should proceed as planned, (ii) a sample size increase is needed, or (iii) the study should be halted for futility. DiaMedica will remain blinded to the data at the interim.
“The IND clearance of the Phase 2/3 study of DM199 for acute ischemic stroke represents a major milestone for DiaMedica as we work to bring new hope and options to patients who experience an acute ischemic stroke,” said Rick Pauls, President and Chief Executive Officer of DiaMedica. “We look forward to further studying the potential of DM199 and moving closer to providing a much-needed new treatment option for the more than 10 million people globally who experience an acute ischemic stroke each year and do not have a treatment option today.”
About Acute Ischemic Stroke
Acute Ischemic Stroke (AIS) is a serious medical emergency caused by sudden loss of blood flow to an area of the brain, resulting in localized damage to the brain, often causing disability or death. Treatment for AIS is limited to dissolving blood clots with a medication (tissue plasminogen activator) in the first 4.5 hours after stroke onset or physical removal of the blockage (mechanical thrombectomy) up to 24 hours after onset in select patients. Globally, there are approximately 13 million AIS cases with approximately 5 million deaths each year and less than 20% have a treatment option which represents a significant unmet medical need.
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 increases production of nitric oxide and prostaglandin. KLK1 deficiency may play a role in multiple vascular and fibrotic diseases such as chronic kidney disease, retinopathy, stroke, vascular dementia, and resistant hypertension where current treatment options are limited or ineffective. DiaMedica is the first company to have developed a recombinant form of the KLK1 protein. The KLK1 protein, produced from porcine pancreas 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 and chronic kidney disease.
About DiaMedica Therapeutics Inc.
DiaMedica Therapeutics Inc. (Nasdaq: DMAC) is a clinical stage biopharmaceutical company focused on developing novel treatments to improve the lives of patients with neurological and chronic kidney diseases. To learn more about DiaMedica, visit www.diamedica.com.
SOURCE: DiaMedica Therapeutics