DiaMedica Therapeutics plans to complete the interim analysis for its ReMEDy2 acute ischemic stroke trial by the end of 2026 [1].
This timeline is critical for the company as it seeks to prove the efficacy and safety of its DM199 program. Positive results from the stroke trial and the company's concurrent preeclampsia program could pave the way for broader regulatory approval and clinical adoption of the therapy.
Julie Krop, the company's chief medical officer, said the firm is reiterating its guidance to finish the interim analysis by the second half of 2026 [2]. The analysis may involve a resample size of 300 to 700 patients [1].
Enrollment for the stroke trial is currently progressing toward its initial target. Krop said the trial is now approaching 70% enrollment of the planned 200 patients [2]. This indicates that approximately 140 patients have already been enrolled in the global clinical program [2].
Dietrich Pauls, president of DiaMedica, said the company is pleased with the progress made so far in 2026. He said the firm continues to advance DM199 across both the preeclampsia and acute ischemic stroke programs [2].
While the company maintains its goals for the stroke trial, other timelines have shifted. The expansion of the preeclampsia Part 1a, which some reports indicated was expected to finish in the first half of 2026 [1], is now targeting the second half of 2026 [2].
“The stroke trial is now approaching 70% enrollment of the planned 200 patients.”
The shift in the preeclampsia timeline and the specific resample size for the ReMEDy2 analysis suggest that DiaMedica is refining its data requirements to ensure statistical significance. By targeting the second half of 2026 for both major program updates, the company is aligning its clinical milestones, which will likely determine the future investment and regulatory strategy for the DM199 compound.
