Business
DiaMedica Therapeutics Provides a Business Update and Announces Third Quarter 2021 Financial Results
Conference Call and Webcast November 11 at 8:00 am Eastern Time / 7:00 am Central Time First Patient Dosed in Phase 2/3 ReMEDy2 Acute Ischemic Stroke Trial
About this update from Diamedica Therapeutics Inc.
[{"type":"text","content":"\nConference Call and Webcast November 11 at 8:00 am Eastern Time / 7:00 am Central Time\n\n\nFirst Patient Dosed in Phase 2/3 ReMEDy2 Acute Ischemic Stroke Trial\n\n\nFast Track Designation Granted to DM199 for the Treatment of Acute Ischemic Stroke\n\n\nFDA Accepts ReMEDy2 Protocol Amendment Elevating Stroke Recurrence to Primary Endpoint\n\n\nBalance Sheet Strengthened with $30 Million Private Placement\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 September 30, 2021. Management will host a conference call Thursday, November 11, 2021, at 7:00AM Central Time/8:00AM Eastern Time to discuss its business update and third quarter financial results.\n\nPivotal Phase 2/3 ReMEDy Trial of DM199 for Acute Ischemic Stroke Initiated & First Patient Dosed\n\nThe Company previously announced the initiation of the first site and today announced dosing of the first patient for its pivotal ReMEDy2 trial. The ReMEDy2 trial is a randomized, double-blind, placebo-controlled Phase 2/3 adaptive trial intended to enroll approximately 350 patients. Patients enrolled in the study will be treated with either DM199 or placebo within 24 hours of the onset of acute ischemic stroke (AIS) symptoms. The trial is studying AIS in a patient population for whom thrombolysis and/or a catheter-based procedure, mechanical thrombectomy, are not medically appropriate or available due to constraints of clot location, comorbidity risks or time from estimated onset of stroke, which represents approximately 80% of all AIS patients.\n\nAlso as previously announced, the U.S. Food and Drug Administration (FDA) has accepted the Company’s protocol amendment to evaluate the effects of DM119 on the rate of recurrent AIS as a second, independent, primary endpoint. The FDA’s acceptance of the amendment allows the Company to evaluate the effects of DM199 on both stroke recoveries post AIS, as measured by the well-established modified Rankin Scale (mRS), and the incidence of AIS recurrence at day 90 as two separate, independent, primary endpoints, with each statistically powered for success. Recurrent strokes represent 25% of all ischemic str...