Clinical Trials

At DiaMedica Therapeutics, our goal is to develop innovative treatments where there is significant unmet clinical need or where no current therapies are available with a focus on neurological and kidney diseases. Our dedicated team includes investigators and trial participants who work together to advance our therapeutics through the many parts and phases of the trial. Each member of our team plays a critical role in contributing to our understanding of the disease states and demonstrating how potential new therapies can improve treatment options.

CURRENT CLINICAL TRIALS

REMEDY Clinical Trial

REMEDY is a multi-center, double-blind, randomized, placebo-controlled Phase 2 clinical trial investigating DM199 treatment in patients who have suffered an acute ischemic stroke. The trial is scheduled to enroll approximately 60 patients with acute ischemic stroke 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 22 days. The primary endpoints 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.

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

DiaMedica is also pleased to announce that the Australasian Stroke Network ("ASTN") has endorsed the REMEDY trial. The ASTN is the key organization that promotes, facilitates, and coordinates stroke clinical trials in Australia and New Zealand. The ASTN endorses clinical trials based on protocol quality and feasibility, assists with study site identification, facilitates study logistics, and supports patient enrollment efforts.

To learn more about this study or to see if you qualify, visit REMEDY Clinical Trial.

COMPLETED CLINICAL TRIALS

DM199 Ascending Dose Study

This is a Phase 1B study to assess the safety, tolerability, and pharmacokinetics of DM199 in healthy volunteers. The study consisted of two parts: Part A focused on intravenous dosing and Part B directly compared intravenous dosing with subcutaneous dosing. To learn more about this study, visit DM199 Ascending Dose Study.

DM199 Four Part Single and Multiple Ascending Study in Healthy Subjects and Type 2 Diabetes Patients

This is a Phase 1/2A study to investigate to what extent DM199 is safe and tolerated. Further, it investigated how quickly and to what extent DM199 is absorbed and eliminated from the body (this is called pharmacokinetics). In addition, the effect of the compound on the body was investigated (this is called pharmacodynamics).  The primary objective was to evaluate the safety, tolerability, and pharmacokinetic profile of single and multiple subcutaneous doses of DM199 in healthy subjects and type 2 diabetes mellitus patients.

The study consisted of 4 parts. Part A - single ascending in healthy subjects, Part B - single ascending in type 2 diabetic patients, Part C - multiple ascending, and Part D - 28-day dosing in type 2 diabetes mellitus patients.

 To learn more about this study, visit DM199 Four Part Single and Multiple Ascending Study.

To learn more about DiaMedica Therapeutics' current clinical trials, please visit www.clinicaltrials.gov