DiaMedica (DMA.V) Initiates Phase II Trial of DM199 in Patients with Acute Ischemic Stroke

By Grant Zeng, CFA

TSX:DMA.V

On September 11, 2017, DiaMedica (DMA.V) announced the initiation of a Phase II REMEDY clinical trial assessing the safety, tolerability, and markers of therapeutic activity of DM199 (recombinant human KLK1) in patients suffering from acute ischemic stroke (AIS).

REMEDY is a multi-center, double-blind, randomized, placebo-controlled Phase II clinical trial investigating DM199 treatment in patients who have suffered a moderate to moderately severe acute ischemic stroke. The trial is scheduled to enroll approximately 60 patients with AIS who will be randomized to receive either DM199 or placebo. The study drug (DM199 or placebo) will be administered as an intravenous infusion (within 24 hours of stroke symptom onset) followed by subcutaneous injections for 21 days.

• The primary end points will be safety and tolerability.
• Secondary endpoints will consist of monitoring drug exposure, along with multiple tests designed to investigate DM199’s therapeutic potential including plasma-based biomarkers and standard functional stroke measures assessed at 90 days post-stroke.

Bruce Campbell is the Principal Investigator of the study. Campbell is a neurologist and Head of Hyperacute Stroke in the Department of Neurology, Royal Melbourne Hospital (RMH). He is a principal research fellow in the Melbourne Brain Centre at RMH, Department of Medicine, University of Melbourne.

DiaMedica intends to seek worldwide approval for DM199 as a novel therapy for acute ischemic stroke (AIS). The company will also position DM199 in China as an improved product over the urine-sourced KLK1 protein currently used there. With the potential that effective treatment can be initiated up to 48 hours after the first sign of symptoms, DM199 may fill a large unmet need for stroke patients who cannot receive tPA, benefiting millions of people around the world who currently have limited treatment options.

Furthermore, DiaMedica has received several licensing term sheets from Asian pharmaceutical companies for potential regional licensing rights and the Company is continuing discussions for potential licensing and/or joint venture opportunities. Since April 1st, the Company has continued ongoing discussions with potential partners.

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