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DiaMedica Therapeutics Announces First Patient Dosed in REDUX Phase II Clinical Trial of DM199 for the Treatment of Chronic Kidney Disease
MINNEAPOLIS--(BUSINESS WIRE)-- DiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biotechnology company, today announced dosing of the first
About this update from Diamedica Therapeutics Inc.
[{"type":"text","content":" MINNEAPOLIS--(BUSINESS WIRE)--\nDiaMedica Therapeutics Inc. (Nasdaq: DMAC), a clinical-stage biotechnology company, today announced dosing of the first patient in its REDUX Phase II study of DM199 for the treatment of Chronic Kidney Disease (CKD). This study is designed to investigate the safety, tolerability and efficacy of DM199 for the treatment of CKD in African Americans with hypertension and CKD in individuals with IgA Nephropathy.\n\n\n“We are thrilled to announce dosing of the first patient in our Phase II CKD study, a significant milestone in the development of DM199,” said Dr. Harry Alcorn, Chief Medical Officer of DiaMedica Therapeutics. “We believe that DM199 protein replacement therapy could have a meaningful impact on the lives of patients with chronic kidney disease.”\n\n\nAbout the REDUX Phase II Trial of DM199 for Chronic Kidney Disease\nThe Phase II REDUX clinical trial is a multi-center, open-label investigation of 60 participants with Stage II or III CKD, who will be enrolled in two cohorts (30 participants per cohort). The study will be conducted in the United States at up to 10 sites. Cohort I is in African Americans with hypertension but 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 in participants with IgA Nephropathy (IgAN) previously confirmed by biopsy.\n\n\nThe study will evaluate 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 the estimated glomerular flow rate (eGFR) and albuminuria, as measured by the urinary albumin to creatinine ratio (UACR).\n\n\nFor more information regarding this study, please visit www.clinicaltrials.gov (NCT04123613).\n\n\nDM199 for Chronic Kidney Disease\nCurrently, there is no cure for CKD and treatment involves management of symptoms and efforts to reduce complications and slow progression of the disease. Blood pressure medications, such as angiotensin converting enzyme inhibitors (ACEi) or angiotensin receptor blockers (A...