Business
DiaMedica Therapeutics Provides a Business Update and Announces Third Quarter 2024 Financial Results
Conference Call and Webcast Thursday November 14 at 8:00 AM Eastern Time / 7:00 AM Central Time Implemented Updates to AIS Program Intended to Enhance
About this update from Diamedica Therapeutics Inc.
[{"type":"text","content":"\nConference Call and Webcast Thursday November 14 at 8:00 AM Eastern Time / 7:00 AM Central Time\n\n\n\nImplemented Updates to AIS Program Intended to Enhance Probability of Trial Success and Expedite Study Completion, with Potential for a Reduced Study Size\n\n\n\nPreeclampsia Phase 2 Trial Received Regulatory Approval and First Patient Dosed\n\n\n\nCash Runway Into Q3 2026\n\n\n\n MINNEAPOLIS--(BUSINESS WIRE)--\nDiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for severe ischemic diseases, today provided a business update and financial results for the quarter ended September 30, 2024. Management will host a conference call Thursday, November 14, 2024, at 8:00 AM Eastern Time / 7:00 AM Central Time to discuss its business update and third quarter 2024 financial results.\n\n\nUpdates to ReMEDy2 Acute Ischemic Stroke (AIS) Phase 2/3 Protocol and Statistical Analysis Plan\n\n\nFollowing in-depth discussions of the ReMEDy2 trial with current and prospective investigators, stroke experts and its scientific advisory board, the Company has made certain additional updates to the protocol intended to enhance the probability of success for the trial, principally through two modifications: broadening the trial population to include patients not responding to thrombolytic treatment (tissue plasminogen activator (tPA) or tenecteplase (TNK)) and increasing the sample size of the planned interim analysis. These changes were submitted the United States Food and Drug Administration (FDA) on August 30, 2024, and as no FDA comments have been received to-date, the Company is proceeding with implementation..\n\n\nThe first modification of expanding the trial population will capture patients expected to demonstrate a strong treatment response with a low placebo response, potentially enhancing the primary outcome measure for the ReMEDy2 trial. These patients are considered “non-responders” if they receive thrombolytic therapy but retain a persistent neurologic deficit, meaning that their stroke symptoms do not improve, six or more hours following administration of the thrombolytic. In the Company’s prior ReMEDy1 Phase 2 stroke trial, the subgroup of patients who received tPA (n=20) prior to enrollment showed the highest response rate of any group, with these patients receiv...