DiaMedica Therapeutics Provides Update on ReMEDy2 Trial

DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, announced today that the Company has received further guidance from the U.S. Food and Drug Administration (FDA) regarding the clinical hold on its ReMEDy2 Phase 2/3 trial for the treatment of acute ischemic stroke (AIS). The FDA stated it is maintaining its clinical hold at this time and that additional non-clinical data related to the materials used by a hospital in the IV infusion process is needed to resolve the clinical hold.

In response to the FDA’s clinical hold letter in July 2022 related to three serious adverse event cases of transient acute hypotension during intravenous infusion of DM199, the Company previously submitted to the FDA supporting in vitro data that the etiology (cause) is likely related to switching the type of intravenous (IV) bag used in the prior ReMEDy 1 trial, where no hypotensive episodes were reported, versus the current ReMEDy 2 trial. Hypotension is a known response to DM199 treatment. Significant differences in protein binding were observed between the two types of IV bags used in the studies that the Company believes altered the total amount of drug being administered. Following review of this data, the FDA requested an additional in-use in vitro stability study of the IV administration of DM199 which includes the IV tubing and mechanical infusion pump to further rule out any etiology other than IV bag protein binding. Preparations for these in vitro studies are already underway and the Company will request a Type A FDA meeting to confirm the study design and obtain additional guidance towards lifting the clinical hold and resuming the ReMEDy2 trial. The Company plans to provide an update on the timing of completion of the in-use in-vitro study and data submission following consultation with the FDA.

Rick Pauls, DiaMedica’s Chief Executive Officer, commented “Patient safety remains our top priority. We believe that we now have a clear path to resolving the clinical hold and we are highly focused on resuming the ReMEDy2 trial as quickly as possible.”

The FDA placed a clinical hold on the Company’s Phase 2/3 ReMEDy2 trial following the Company voluntarily pausing patient enrollment in the trial to investigate three unexpected instances of clinically significant hypotension (low blood pressure) occurring shortly after initiation of IV dose of DM199. The hypotension was transient and blood pressure levels of all three patients recovered back to baseline within minutes of stopping the infusion and the patients suffered no ongoing adverse effects.