About ReMEDy2

The ReMEDy2 trial is an adaptive design, randomized, double-blind, placebo-controlled trial studying the use of the Company’s product candidate, DM199 (rhKLK1), to treat acute ischemic stroke (AIS) patients. The trial is intended to enroll a total of approximately 300 patients at up to 100 sites globally, with the final sample size will be determined based upon the results of an interim analysis of 200 participants. 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 who received mechanical thrombectomy (MT) or participants with large vessel occlusions in the intracranial carotid artery or the M1 segment for the middle cerebral, vertebral, or basilary arteries or those that are otherwise eligible for MT. Participants treated with tissue plasminogen activator (tPA) or Tenecteplase (TNK), (thrombolytic agents) intended to dissolve blood clots, are eligible for participation if they continue to experience a persistent neurological deficit after receiving thrombolytic treatment and meet all other trial criteria.

The ReMEDy2 study is registered on Clinicaltrials.gov (NCT# 05065216). The FDA granted Fast Track Designation to DM199 for the treatment of AIS in September 2021. Fast Track is a process intended to facilitate the development and expedite the review of investigational drugs for the treatment of serious or life-threatening conditions where there is a significant unmet medical need.