Business
DiaMedica Therapeutics Provides a Business Update and Announces Second Quarter 2022 Financial Results
Conference Call and Webcast August 11 at 8:00 am Eastern Time / 7:00 am Central Time Company Confident in Plan to Resolve Issues that Led to Clinical Hold of
About this update from Diamedica Therapeutics Inc.
[{"type":"text","content":"\n Conference Call and Webcast August 11 at 8:00 am Eastern Time / 7:00 am Central Time \n\n\nCompany Confident in Plan to Resolve Issues that Led to Clinical Hold of Phase 2/3 ReMEDy2 Trial\n\n\nProposal to Resume Trial Will be Submitted to FDA in September\n\n\nCash Runway Into 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 June 30, 2022. DiaMedica will host a conference call on Thursday, August 11, 2022, at 8:00AM Eastern Time / 7:00AM Central Time, to discuss its business update and second quarter financial results.\n\nClinical Developments\n\nDM199 for the Treatment of Acute Ischemic Stroke\n\nAs previously announced, the U.S. Food and Drug Administration (FDA) placed a clinical hold on the Company’s Phase 2/3 ReMEDy2 trial for the treatment of acute ischemic stroke (AIS). The clinical hold was issued 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 the intravenous (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.\n\nAfter pausing enrollment, the Company immediately initiated an investigation and conducted a comprehensive analysis to determine the likely cause of the hypotensive events. The Company learned that these adverse events likely resulted from changing to a new formulation of IV bag in the ReMEDy2 trial, as compared to the IV bag used in the prior, Australian ReMEDy1 trial, which was not readily available at many U.S. study sites. Recent testing of the prior IV bag has shown that as much as half of the DM199 protein bound to the IV bag used in the prior trial. Whereas, the DM199 protein does not bind to the current IV bag. This effectively increased the dose of DM199 delivered to patients in the current trial as compared to the prior trial. DiaMedica notes that hypotension is a known response to KLK1 therapy and that DiaMedica’s prior sa...