Business
DiaMedica Therapeutics Provides a Business Update and Announces First Quarter 2023 Financial Results
Conference Call and Webcast May 16 at 8:00 am Eastern Time / 7:00 am Central Time Company Completed In-Use Study, Results Support Proposed ReMEDy2 IV Dose
About this update from Diamedica Therapeutics Inc.
[{"type":"text","content":"\nConference Call and Webcast May 16 at 8:00 am Eastern Time / 7:00 am Central Time\n\n\n\nCompany Completed In-Use Study, Results Support Proposed ReMEDy2 IV Dose Revision\n\n\n\nCompany Completed a Phase 1C Study in Healthy Volunteers in Australia Affirming Proposed Revised DM199 IV Dose of 0.5 µg/kg for Continuing the ReMEDy2 Trial\n\n\n\nDiaMedica Plans to File Complete Clinical Hold Response This Week\n\n\n\nCash Runway Into Q4 2024\n\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 quarter ended March 31, 2023. Management will host a conference call Tuesday, May 16, 2023, at 7:00AM Central Daylight Time/8:00AM Eastern Daylight Time to discuss its business update and first quarter 2023 financial results.\n\n\nClinical Developments\n\n\nReMEDy2 Phase 2/3 Trial for Acute Ischemic Stroke – Clinical Hold Update\n\n\nDiaMedica plans to file complete response requesting hold lift this week\n\n\nDiaMedica plans to file a clinical hold response with the U.S. Food and Drug Administration (FDA) by the end of the week. This request for lifting the clinical hold will include the submission of requested additional supporting data to address prior issues that led to the clinical hold in July 2022. DiaMedica has completed supplemental in-use studies as requested by the FDA. These studies, performed at an independent laboratory, were conducted in two parts. Part 1 simulated actual use of DM199 administration in a hospital setting and Part 2 evaluated worst-case scenarios such as varying storage durations, temperature(s) and light exposure to DM199. DiaMedica believes data from Part 1 confirmed its conclusions from prior testing that the intravenous (IV) dose administered in the ReMEDy2 study was higher than planned due to the change in IV bag materials and was the cause of the hypotension. Accordingly, a dose revision in ReMEDy2 from 1.0 µg/kg to 0.5 µg/kg should avoid or minimize the risk of clinically significant hypotension while still reaching what we believe will be a therapeutic blood concentration level. Additionally, results from part 2 of the in-use study were substantially consistent with Part 1 indicating t...