DiaMedica Achieves Positive Phase 2 Interim Data for DM199 in Late-Onset Preeclampsia

Positive interim data from DiaMedica Therapeutics' Phase 2 preeclampsia program are now shaping dose-selection decisions that will directly inform the biologic's eventual process validation strategy and regulatory submission package. For manufacturing and QA leads tracking novel biologic pipelines, the mid-dose range confirmation narrows the design space ahead of any future scale-up.

In Part 1a of the Phase 2 study evaluating DM199 in women with late-onset preeclampsia expecting delivery within 72 hours, the combined final and highest-dose cohorts (n=15; Cohorts 10 and extension) produced a mean 29.1 mmHg reduction in systolic blood pressure from a baseline of 169.3 mmHg (p<0.001) and a 17.0 mmHg reduction in diastolic blood pressure from 103.7 mmHg (p<0.001), measured five minutes post-IV infusion. Systolic pressure remained below 160 mmHg across all measured time points over 24 hours (p<0.01). Reductions in uterine artery pulsatility index observed in Cohorts 4 through 8 are consistent with reduced uteroplacental vascular resistance, suggesting a potential disease-modifying mechanism rather than symptomatic control alone.

The mid-dose range finding carries direct implications for formulation and dosing-regimen decisions that precede any IND amendment or Phase 3 protocol submission. DiaMedica's Chief Medical Officer, Dr. Julie Krop, confirmed that Cohorts 4 through 8 represent the selected range for further clinical evaluation in early-onset preeclampsia and fetal growth restriction studies, providing the dose-bracketing data regulators typically expect before pivotal trial design is locked.

On the fetal growth restriction front, enrollment of the first of three planned cohorts has been completed, six participants at the 5 µg/kg dose level, marking the first clinical use of DM199 in early-onset fetal growth restriction patients. A key opinion leader call with principal investigator Dr. Cathy Cluver is scheduled for September, at which topline results from this cohort will be discussed. Separately, the acute ischemic stroke Phase 2/3 trial is enrolling, with an interim analysis anticipated in Q1 2027.

DiaMedica reported $43.5 million in cash, cash equivalents, and investments as of the reporting period, with runway projected through 2027, a capital position that supports continued clinical operations across all three indications without near-term financing pressure disrupting trial continuity.

The Q1 2027 interim analysis for the acute ischemic stroke program represents the next scheduled data checkpoint with potential to materially influence the regulatory and manufacturing development trajectory for DM199.

Source: DiaMedica Therapeutics, Inc. via Business Wire, August 10, 2026. Management conference call held August 11, 2026, at 8:00 AM Eastern Time / 7:00 AM Central Time; webcast available via company investor relations page.