Business
DiaMedica Therapeutics Provides a Business Update and Announces First Quarter 2021 Financial Results
Investigational New Drug (IND) Application Submitted for Phase 2/3 AIS Study Plan to Initiate Phase 2/3 AIS Trial in Summer 2021 REDUX Phase 2 Diabetic
About this update from Diamedica Therapeutics Inc.
[{"type":"text","content":"\n\nInvestigational New Drug (IND) Application Submitted for Phase 2/3 AIS Study\n\n\nPlan to Initiate Phase 2/3 AIS Trial in Summer 2021\n\n\nREDUX Phase 2 Diabetic Kidney Disease Cohort Readout Expected in Q2 2021 \n\n\nCash Runway Through Mid-2022\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, 2021. DiaMedica will host a conference call Thursday, May 6, 2021, at 7:00 a.m. Central Time to discuss its business update and first quarter financial results.\n\nClinical Developments\n\nDM199 for the Treatment of Acute Ischemic Stroke\n\n\nIND Submitted\n\n\nInitiation of Phase 2/3 Trial of DM199 in AIS in Summer 2021\n\n\nDiaMedica has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for an adaptive Phase 2/3 clinical trial of DM199, the Company’s recombinant form of human tissue kallikrein-1 being developed as a treatment for acute ischemic stroke (AIS) patients. The proposed trial of DM199 is for AIS patients who do not receive tissue plasminogen activator (tPA) and do not have large vessel occlusions, a group that represents up to 80% of all AIS patients. DiaMedica believes that the proposed trial has the potential to serve as a pivotal registration study of DM199 in this patient population.\n\nThe FDA has confirmed its receipt of the IND and DiaMedica expects the FDA to complete its regulatory review of the IND by mid-May. If authorized by the FDA, the Company anticipates initiating the study this summer. DiaMedica has selected a contract research organization to assist with the conduct of the study and is actively working to identify, qualify and engage clinical study sites—the expected pacing item for initiation of the study.\n\nThe clinical trial is proposed to be a double blinded, placebo controlled, randomized study of approximately 350 participants, based on a 90% powering for statistical significance on the primary endpoint of modified Rankin Scale (mRS) at day 90. Secondary endpoints will include stroke recurrence, mRS shift, NIHSS and Barthel Index, deaths, safety and tolerability measures, and biomarkers relating to KL...