Business
DiaMedica Therapeutics Provides a Business Update and Announces Third Quarter 2022 Financial Results
Company to Conduct In-Use Study to Address FDA Latest Information Request Cash Runway Into Q4 2024 MINNEAPOLIS--(BUSINESS WIRE)-- DiaMedica Therapeutics Inc.
About this update from Diamedica Therapeutics Inc.
[{"type":"text","content":"\n\nCompany to Conduct In-Use Study to Address FDA Latest Information Request\n\n\n\nCash Runway Into Q4 2024\n\n\n MINNEAPOLIS--(BUSINESS WIRE)--\nDiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and kidney diseases, today provided a business update and released financial results for the quarter ended September 30, 2022.\n\nClinical Developments\n\nDM199 for the Treatment of Acute Ischemic Stroke\n\nOn October 26, 2022, the Company announced that it received further guidance from the U.S. Food and Drug Administration (FDA) regarding the clinical hold on its ReMEDy2 Phase 2/3 trial. 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 intravenous (IV) infusion process is needed to resolve the clinical hold.\n\nIn 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 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 effectively 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.\n\n“Preparation for the in vitro study is already underway and we are also preparing to request a Type A FDA meeting in the coming weeks to obtain additional guidance towards lifting the clinical hold and resuming the ReMEDy2 trial,” commented Rick Pauls, DiaMedica’s Chief Executive Officer. “We will provide an update on the timing of completion of the in-use in-vitro study and data submission following consultation with the FDA.”\n\nThe FDA placed a clinical hold on the Company’s Phase 2/3 ReMEDy2 tr...