The FDA has removed a clinical hold placed on DiaMedica’s (NASDAQ:DMAC) investigational new drug application for its ReMEDy2 Phase 2/3 clinical trial studying DM199 in the treatment of acute ischemic stroke (AIS) and that preparations are underway to resume the ReMEDy2 trial as soon as possible.
DM199, a synthetic formulation of the human tissue-1 kallikrein protein, represents a novel approach to treating AIS patients, principally aimed at enhancing collateral blood flow in the brain tissues affected by the stroke,” Rick Pauls, president and CEO of DiaMedica, said in a statement.
The trial is intended to enroll about 350 patients at 75 sites in the United States. Patients enrolled in the trial will be treated for three weeks with either DM199 or placebo, beginning within 24 hours of the onset of AIS symptoms, with the final follow-up at 90 days.
The trial excludes patients treated with tissue plasminogen activator (tPA) and/or mechanical thrombectomy.
DiaMedica believes that the proposed trial has the potential to serve as a pivotal registration study of DM199 in this patient population.
