US-based biopharmaceutical firm DiaMedica Therapeutics has begun a Phase II clinical trial (REMEDY) of its therapeutic candidate DM199 for the treatment of patients with acute ischemic stroke.

DM199 is a synthetic recombinant human tissue kallikrein (KLK1) being developed for neurological and kidney disorders.

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The recombinant KLK1 protein is designed to stimulate molecular pathways involved in the improvement of vasodilation, angiogenesis and blood flow.

It minimises fibrosis, inflammation and oxidative stress to protect brain tissue against damage from a stroke.

The multi-centre, double-blind, randomised, placebo-controlled Phase II trial will evaluate the safety, tolerability and clinical effect of DM199 in 60 patients with a history of a moderate-to-moderately severe acute ischemic stroke.

During the trial, an intravenous infusion of the study drug will be given within 24 hours of onset of stroke symptoms, followed by subcutaneous injections for 21 days.

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"The design of the REMEDY trial will benefit from the recently completed bridging clinical trial that identified a DM199 dosing strategy that restores deficient KLK1 levels and has a superior pharmacokinetic profile than the approved Kailikang product."

The trial’s primary endpoints are safety and tolerability, while secondary endpoints include drug exposure monitoring and various tests such as plasma-based biomarkers and standard functional stroke measures for DM199’s therapeutic potential.

DiaMedica Therapeutics president and CEO Rick Pauls said: “The design of the REMEDY trial will benefit from the recently completed bridging clinical trial that identified a DM199 dosing strategy that restores deficient KLK1 levels and has a superior pharmacokinetic profile than the approved Kailikang product.”

DM199 has previously been studied in five clinical trials to assess its single and multiple ascending doses for determination of dosing strategies.

The therapeutic candidate is reported to have demonstrated good safety and tolerability with intended activity of reducing blood pressure.