Benzinga | Jun 29, 2021 07:00AM EDT

DiaMedica Therapeutics Announces Interim Results From Phase 2 REDUX Study In CKD; Says Results 'Affirm Biological Activity, Safety and Tolerability of DM199' And Indicate 'Statistically and Clinically Significant Reduction in UACR'

* Results Affirm Biological Activity, Safety and Tolerability of DM199 Consistent with Porcine KLK1 Product in Asia

* Early Data Indicate Statistically and Clinically Significant Reduction in UACR seen in IgA Nephropathy and Hypertensive African Americans -- a Key Risk Factor in Predicting Kidney Disease Progression

* Study Demonstrates Stable eGFR and Positive Effects on Blood Pressure Across All Cohorts

Company to discuss REDUX interim data on conference call and webcast today at 8:00 am Eastern Time / 7:00 am Central Time

DiaMedica Therapeutics Inc. (NASDAQ:DMAC), a clinical-stage biopharmaceutical company focused on developing novel treatments for neurological disorders and cardio-renal diseases, today announced positive interim results from its Phase 2 REDUX trial of DM199 in chronic kidney disease (CKD). The REDUX trial is studying the treatment of CKD in three populations with rare or high unmet medical needs: African Americans (AA), non-diabetic and hypertensive (Cohort 1, n=12); IgA Nephropathy (IgAN) (Cohort 2, n=16); and diabetic kidney disease (DKD) (Cohort 3, n=28). All participants have proteinuria and an eGFR between 30-90 ml/min/1.73m2.

DM199 is demonstrating clinically meaningful improvements in kidney function in Cohorts 1 and 2, as measured by simultaneously stabilizing estimated glomerular filtration rate (eGFR) and decreasing urine albumin-to-creatinine ratio (UACR). In participants who were hypertensive (Cohorts 1 and 3), DM199 also reduced blood pressure by clinically significant levels. DiaMedica reported the following preliminary data:

* AA: Decrease in UACR -27% in moderate to severe albuminuria (baseline UACR >500) (n=6), Increase in eGFR +2 ml/min (n=12) and decrease in blood pressure -8/-3 mmHg;

* IgAN: UACR decreased by -33% (P=0.002) (baseline UACR>500) (n=11) and eGFR and blood pressure were stable (n=16);

* DKD: eGFR and UACR levels were stable and blood pressure decreased significantly by -5/1 mmHg (n=28)

DM199 was well tolerated across all cohorts, with no DM199 related severe adverse events (SAEs) or discontinuations due to drug-related adverse events (AEs). AEs were generally mild to moderate in severity, with the most common being local injection site irritation that resolved.

"This data provides further clinical validation of the meaningful biologic activity of the recombinant KLK1 (DM199) and support the potential of achieving clinical benefit equal to or better than the exogenous KLK1 product available in Asia," said Rick Pauls, President and Chief Executive Officer of DiaMedica. "We are optimistic as we continue the trial of DM199 in IgAN and hypertensive African Americans with CKD and begin the pivotal Phase 2/3 study in acute ischemic stroke later this summer."

Dr. Rajiv Agarwal, Professor of Medicine at Indiana University School of Medicine and member of the DiaMedica Scientific Advisory Board, noted that, "though these data are preliminary, they are encouraging signals of the role DM199 can play in treating kidney disease patients with significant unmet needs, particularly African Americans with uncontrolled hypertension. The observed improvements in eGFR, UACR and blood pressure all point to the important physiological effects of DM199 treatment and strongly support additional clinical study."

Conference Call and Webcast Information:

DiaMedica will host a live conference call and webcast on Tuesday June 29, 2021 at 7:00 am Central Time/8:00 am Eastern Time to discuss the interim REDUX CKD results.

Date: Tuesday, June 29, 2021

Time: 7:00 AM CT / 8:00 AM ET

Web access: https://event.on24.com/wcc/r/3220309/ 67847BACCFE4F4EA5C4CC7DBF66259E0

Dial In: (866) 393-4306 (domestic)

(734) 385-2616 (international)

Conference 2847537ID:

Interested parties may access the conference call by dialing in or listening to the simultaneous webcast. Listeners should log on to the website or dial in 15 minutes prior to the call. The webcast will remain available for play back on DiaMedica's website, under investor relations - events and presentations, following the earnings call and for 12 months thereafter. A telephonic replay of the conference call will be available until July 6, 2021, by dialing (855) 859-2056 (US Toll Free), (404) 537-3406 (International), and entering the replay passcode: 2847537.