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 kidney and neurological 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

Acute Ischemic Stroke - REMEDY phase II 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 100 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.

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

Chronic Kidney Disease - Phase Ib Clinical Trial

DiaMedica Therapeutics is conducting a Phase Ib multi-center study in patients with chronic kidney disease (CKD). This study will be conducted in CKD patients with moderate or severe impairment of kidney function. This is an open-label, single-dose study to investigate three dosage levels of DM199. The primary endpoints of the study are safety, tolerability and pharmacokinetics. The study also will measure renal biochemical markers that are associated with kidney function and the potential action of DM199.   The Company anticipates identifying dosing of DM199 that can normalize the levels of KLK1, which is believed to be critical for maintaining kidney health.  This study will provide important information to help design upcoming Phase II studies in patients with CKD.

The Phase Ib study will be conducted at three clinical trial sites in the United States under a recently approved Investigational New Drug application from the US Food and Drug Administration.

To learn more about this study or if you are interested in participating please visit CKD Clinical Trial

 

COMPLETED CLINICAL TRIALS

DM199 Ascending Dose Study

This was 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

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.

  • Part A was a randomized, double-blinded, placebo-controlled, single ascending dose (SAD) study in healthy male and/or female subjects. Subjects received DM199 or placebo subcutaneously (SC).
  • Part B was a randomized, partially double-blinded, placebo-controlled, sequential SAD study in male and/or female type 2 diabetes mellitus patients.
  • Part C was a randomized, double-blinded, placebo-controlled, 14-day multiple ascending dose (MAD) study in healthy male and/or female subjects each. Subjects received sequential doses of DM-199 or placebo SC for 14 days.
  • Part D was a randomized, double-blinded, placebo-controlled, 28-day multiple-dose study in male and/or female type 2 diabetes mellitus patients. Subjects received parallel doses of DM199 or placebo SC for 28 days.

The primary objective was to evaluate the safety and tolerability of single and multiple subcutaneous doses of DM199 in healthy subjects and type 2 diabetes mellitus patients. Another objective is to determine the plasma pharmacokinetic profile of DM199 after administration of single and multiple doses of DM199 in healthy subjects and 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