Business
DiaMedica Announces Positive Results in Top-Line Data from the Phase II ReMEDy Acute Ischemic Stroke Study and Provides a Business Update and First Quarter 2020 Financial Results
DM199 Met Primary Safety and Tolerability Endpoints in ReMEDy Study Top-Line Data Demonstrated Therapeutic Effect in Patients Not Pre-treated with Mechanical
About this update from Diamedica Therapeutics Inc.
[{"type":"text","content":"\n\nDM199 Met Primary Safety and Tolerability Endpoints in ReMEDy Study Top-Line Data\n\n\nDemonstrated Therapeutic Effect in Patients Not Pre-treated with Mechanical Thrombectomy\n\n\nDiaMedica Completes $8.5M Public Offering of Common Shares\n\n\nCash and Investments of $12.6 Million; Runway Through 2021\n\n\nConference Call with Management Tomorrow, May 14 at 7am CT\n\n\n MINNEAPOLIS--(BUSINESS WIRE)--\nDiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for kidney diseases and neurological disorders, today announced positive top-line results from ReMEDy, its Phase II study in acute ischemic stroke (AIS), as well as provided a business update and financial results for the three months ended March 31, 2020. DiaMedica will host a conference call with slides tomorrow, May 14, 2020, at 7:00 a.m. Central Time to discuss its ReMEDy top-line data, business update and first quarter financial results. In conjunction with this release, DiaMedica also issued today a separate more detailed release on the ReMEDy top-line data.\n\n\nClinical Developments\n\n\nDM199 for the Treatment of Acute Ischemic Stroke\n\n\nDM199 Acute Ischemic Stroke Phase II “ReMEDy” Trial – Positive Top-Line Data\n\n\nDiaMedica today announced positive top-line results from its ReMEDy trial, a Phase II study assessing the safety, tolerability and therapeutic potential of DM199 in participants suffering from AIS. Final enrollment was 92 participants. The markers of therapeutic efficacy included the National Institutes of Health Stroke Scale, Modified Rankin Scale and the Barthel Index and multiple plasma-based biomarkers (e.g. C-reactive protein). These markers were assessed at multiple points throughout the study, including 90 days post-stroke.\n\n\nDM199 met primary safety and tolerability endpoints and no DM199-related serious adverse events were noted in the study. According to top-line phase II results, there was also a demonstrated therapeutic effect in participants who received tissue plasminogen activator (tPA) prior to enrollment, but not in participants receiving mechanical thrombectomy.\n\n\n\"We are very excited about the positive top-line results which continue to demonstrate the excellent safety profile of DM199 and efficacy signals which are consistent with the approval study fo...