Business
DiaMedica Therapeutics Provides a Business Update and Announces Full Year 2022 Financial Results
Conference Call and Webcast March 29 at 8:00 am Eastern Time / 7:00 am Central Time Company has had Ongoing and Successful Communications with the FDA to
About this update from Diamedica Therapeutics Inc.
[{"type":"text","content":"\nConference Call and Webcast March 29 at 8:00 am Eastern Time / 7:00 am Central Time\n\n\nCompany has had Ongoing and Successful Communications with the FDA to Address the Clinical Hold\n\n\nCompany Completed Part 1 of In-Use Study, Results Support Proposed ReMEDy2 Dose Revision\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 financial results for the year ended December 31, 2022. Management will host a conference call Wednesday, March 29, 2023, at 7:00AM Central Daylight Time/8:00AM Eastern Daylight Time to discuss its business update and full year 2022 financial results.\n\nClinical Developments\n\nReMEDy2 Phase 2/3 Trial - Clinical Hold Update\n\nIn July 2022, the U.S. Food and Drug Administration (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 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\nIn October 2022, the Company announced that the FDA continued the clinical hold and requested that the Company perform an additional in-use in vitro stability study of the IV administration of DM199 to fully identify all potential factors causing or contributing to the three unexpected instances of clinically significant hypotension occurring shortly after initiation of the IV dose of DM199. An in-use study includes testing the combination of the IV bag, IV tubing and any materials used during the infusion that come in contact with DM199 and the mechanical infusion pump in a manner that simulates the actual usage in a hospital. In December 2022, DiaMedica received written comments from the FDA clarifying its expectations for the design of the in-use study. These comments were incorporated into the study protocol and submitted to the FDA. In response, the FDA recently indicated that the protocol app...