DiaMedica Therapeutics Announces Publication of Positive Clinical Results for DM199 in the International Journal of Clinical Trials
MINNEAPOLIS, Nov. 07, 2017 (GLOBE NEWSWIRE) -- DiaMedica Therapeutics Inc. (the “Company”) (TSX Venture:DMA) (OTCQB:DMCAF), a clinical stage biopharmaceutical company focused on improving the lives of patients with neurological and kidney diseases associated with low KLK1 levels, announced the publication of positive results from its Phase Ib bridging trial. The study was designed to compare the profile of DM199 to that of the approved urinary KLK1 product (trade name Kailikang®) on the market in Asia for acute ischemic stroke. The reference drug is administered intravenously and has a very short pharmacokinetic profile. The DiaMedica study identified an intravenous dose of DM199 having a similar pharmacokinetic profile to urinary KLK1 along with a superior subcutaneous dosing strategy.
The paper, entitled “Safety, tolerability, and pharmacokinetic profile of recombinant human tissue kallikrein, DM199, after intravenous and subcutaneous administration in healthy volunteers”, established the pharmacokinetic profile of DM199 when administered intravenously or subcutaneously in 36 healthy volunteers. A 30-minute infusion delivered intravenously showed rapid exposure of plasma DM199 with a short exposure window. A single subcutaneous injection provided sustained exposure of plasma DM199. The sustained plasma level of DM199 is superior to Kailikang®. DM199 was safe and well tolerated following both routes of administration with no treatment limiting adverse events. The Company plans to use the results of this study to guide Phase II dosing in upcoming clinical trials.
“We are happy to have the results of our recent trial published in an important peer-reviewed journal. This publication provides significant validation for the ongoing clinical development of DM199,” said Dr. Todd Verdoorn, Chief Scientific Officer of DiaMedica. “The results of the study fully support our Phase II REMEDY trial that is designed to test the action of DM199 in ischemic stroke patients.”
DM199 has the same amino acid sequence as the reference drug, identical biochemical activity, and similar physiological effects. The results from the Phase Ib study show that the dosing of DM199 will be significantly more convenient and potentially provide improved efficacy compared to the limited exposure of the reference drug. This profile should allow DM199 to be safely and conveniently administered to stroke patients during their initial hospitalization and after they are sent home. The sustained plasma exposure of DM199 should provide continuous enzyme replacement therapy to optimally benefit patients and is potentially superior to the urinary form of KLK1, Kailikang®, a prescription drug approved in China for acute ischemic stroke.
About Acute Ischemic Stroke
An acute ischemic stroke is characterized by rapid loss of brain function due to an interruption of blood supply to the brain due to a blood clot. Affected areas of the brain become inactive and cells eventually die causing neurological impairment. Each year over 12 million people worldwide suffer an acute ischemic stroke and it is the leading cause of death and disability globally. The only approved U.S. Food and Drug Administration (“FDA”) or European Medicines Agency (“EMA”) drug treatment is tPA (Activase®) manufactured by Genentech. However, only 5-7% of acute ischemic stroke patients are actually treated with tPA due to eligibility and other issues.
DM199 is a recombinant (synthetic) human tissue kallikrein (“KLK1”) protein to treat neurological and kidney diseases. DiaMedica has completed five clinical trials with DM199, including single ascending and multiple ascending doses, studies in diabetic patients, and a Phase I pharmacokinetic study to confirm dosing strategies. In addition to a good safety and tolerability profile, DM199 modestly reduced blood pressure in multiple studies as expected based on its biochemical activity. DM199 also significantly increased cerebral blood flow in a preclinical rat study.
About DiaMedica Therapeutics Inc.
DiaMedica Therapeutics is a clinical stage biopharmaceutical company focused on developing novel treatments for neurological and kidney diseases. DiaMedica’s shares are listed on the TSX Venture Exchange under the trading symbol “DMA” and on the OTCQB under the trading symbol “DMCAF”. For more information, please visit www.diamedica.com. Follow us on social media - Twitter, LinkedIn.
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Source: DiaMedica Therapeutics Inc.