FDA removes hold on investigational new drug application for ischemic stroke therapy

The FDA has removed the clinical hold on the investigational new drug application for the phase 2/3 ReMEDy2 trial of DM199 for acute ischemic stroke, DiaMedica Therapeutics announced in a press release.

“We are pleased that the FDA has fully lifted the clinical hold,” DiaMedica President and CEO Rick Pauls, MBA, said in the release. “DM199 represents a novel approach to treating [acute ischemic stroke] patients, principally aimed at enhancing collateral blood flow in the brain tissues affected by the stroke.”

According to the release, DM199 is a synthetic form of human tissue kallikrein-1, a serine protease involved in several physiological processes, including blood flow, inflammation, fibrosis, oxidative stress and neurogenesis. Deficiency of the protein may play a role in vascular disease such as stroke and vascular dementia.

The company plans to resume its ReMEDy2 trial as soon as possible and aims to enroll approximately 350 individuals at 75 sites in the U.S. Participants will receive DM199 or placebo for 3 weeks, beginning within 24 hours of acute ischemic stroke symptoms, with the final follow-up scheduled for 90 days.

“We look forward to re-engaging with our study sites and stroke expert principal investigators as we resume our ReMEDy2 trial, as there is continued unmet need of new potential therapeutics for patients who have had an ischemic stroke,” Kirsten Gruis, MD, DiaMedica’s chief medical officer, said in the release.