Benzinga | Sep 14, 2020 09:15AM EDT

DiaMedica Reports First Patients Dosed In Diabetic Kidney Disease Cohort In Phase 2 REDUX CKD Study

DiaMedica Therapeutics Inc. (NASDAQ:DMAC), a clinical-stage biopharmaceutical company developing novel treatments for chronic kidney disease, today announced dosing of the first participants in the diabetic kidney disease (DKD) cohort of the REDUX Phase II Chronic Kidney Disease (CKD) study. In total, 16 additional participants have been enrolled in the REDUX study in the past six weeks, 11 of which were enrolled in the DKD cohort III, bringing the total enrolled participants to 34, including 11 African American subjects into cohort I and 12 subjects with IgA Nephropathy (IgAN) into cohort II of the REDUX study.

"We are very pleased with the recent uptick in enrollments in the REDUX trial and with the ability of our current study sites to identify, screen and enroll DKD participants," commented Dr. Harry Alcon, Jr., Chief Medical Officer of DiaMedica Therapeutics, "we are further encouraged by these enrollments given that approximately half of our study sites remain unable to enroll new subjects as they continue to struggle with restrictions related to COVID-19. At this time, we are hopeful recruitment continues to improve; however, with the flu season approaching and COVID-19 still in play, we will continue to monitor and support our sites for enrollment."

The Phase II REDUX clinical trial is a multi-center, open-label investigation targeting 90 participants with Stage II or III CKD, who will be enrolled in three equal cohorts. The study is being conducted in the United States at up to 13 sites. Cohort I is studying African Americans with hypertension but who are not diabetic. African Americans are at greater risk for CKD than Caucasians and those who have the APOL1 gene mutation are at an even higher risk. The study is designed to capture APOL1 gene mutation as an exploratory biomarker in this cohort. Cohort II is studying participants with IgA Nephropathy previously confirmed by biopsy. Cohort III is studying participants with Type II diabetes mellitus, hypertension and albuminuria.

The REDUX study is evaluating two dose levels of DM199 within each cohort. Study participants will receive DM199 by subcutaneous injection twice weekly for 95 days. The primary study endpoints include safety, tolerability, blood pressure, albuminuria and kidney function, which will be evaluated by changes from baseline in eGFR and albuminuria, as measured by the urinary albumin to creatinine ratio (UACR). Secondary endpoints are focused on evaluating the potential for DM199 to positively impact the underlying disease causing each participant's kidney disease.