DiaMedica Therapeutics Announces Enrollment of Last Patient in Diabetic Kidney Disease Cohort of Phase 2 REDUX CKD Study

Rhea-AI Summary

DiaMedica Therapeutics Inc. (Nasdaq: DMAC) announced that enrollment in the diabetic kidney disease cohort of its Phase 2 REDUX chronic kidney disease study is complete, with all participants now on treatment. Additionally, 50% enrollment has been achieved in the IgA Nephropathy and African Americans cohorts. This study aims to assess the safety and efficacy of DM199 in approximately 90 participants across three cohorts. Positive results from earlier studies have raised expectations for topline results, anticipated in Q2 2021.

Positive

• Completion of enrollment in the diabetic kidney disease cohort.
• 50% enrollment reached in IgA Nephropathy and African Americans cohorts.
• Positive preliminary results from the Phase 2 stroke study may boost investor confidence.

Negative

• None.

DiaMedica Therapeutics Inc. (Nasdaq: DMAC) today announced that the last participant has been enrolled and is on treatment in the diabetic kidney disease Cohort of the Company’s Phase 2 REDUX chronic kidney disease (CKD) study. The Company also announced that enrollment has reached 50% in the IgA Nephropathy and African Americans cohorts.

DiaMedica’s Phase 2 REDUX (Latin for restore) study is a multi-center, open-label, investigation to assess the safety and efficacy of multiple doses of DM199, administered over 90 days, in participants with CKD (Stage 2 or 3) enrolling approximately 90 participants in three cohorts (30 per cohort). Cohort 1 of the study is focused on non-diabetic, African Americans with hypertension, a group that is at greater risk for CKD than Caucasians. Additionally, the study is designed to identify African American participants with the APOL1 gene mutation as an exploratory biomarker as these individuals have an even higher risk of developing CKD. Cohort 2 of the study is focused on participants with IgA Nephropathy (IgAN) and Cohort 3 includes participants with diabetic kidney disease.

“We’re very grateful to the participants and research site staff for their dedication and commitment in moving the REDUX study forward during this challenging time of Covid-19,” stated DiaMedica’s Chief Medical Officer Dr. Harry Alcorn, Jr. “Given the positive results observed earlier this year in the subset of diabetic participants in our Phase 2 stroke study, we are looking forward to announcing topline results, anticipated in the second quarter of 2021.”

About DiaMedica Therapeutics Inc.

DiaMedica Therapeutics Inc. is a clinical stage biopharmaceutical company focused on developing novel treatments for neurological and chronic kidney diseases. DiaMedica shares are listed on The Nasdaq Capital Market under the trading symbol “DMAC.”

For more information, please visit www.diamedica.com.

View source version on businesswire.com: https://www.businesswire.com/news/home/20201215005118/en/

FAQ

What is the purpose of DiaMedica's Phase 2 REDUX study?

The Phase 2 REDUX study aims to assess the safety and efficacy of DM199 in participants with chronic kidney disease.

When are topline results from the REDUX study expected?

Topline results from the REDUX study are anticipated to be announced in the second quarter of 2021.

What cohorts are included in the REDUX study?

The study includes three cohorts: diabetic kidney disease, IgA Nephropathy, and African Americans with hypertension.

How many participants are being enrolled in the REDUX study?

The REDUX study is enrolling approximately 90 participants, with 30 in each cohort.

What were the preliminary findings from the stroke study related to DM199?

Preliminary results indicated positive outcomes in diabetic participants from the Phase 2 stroke study, encouraging further research.