DiaMedica Therapeutics announced that the 200th patient has been enrolled in its pivotal Phase 2/3 ReMEDy2 trial of DM199 in participants with acute ischemic stroke, AIS, reaching the prespecified enrollment threshold for the trial's planned interim analysis. Under the trial protocol, the interim analysis will be conducted by the independent Data Safety Monitoring Board, DSMB, after the first 200 participants complete their 90-day follow-up. The DSMB will assess the need for a sample size re-estimation to optimize the trial's statistical power or stopping for futility. If the trial continues, the final sample size will range between 300 and 728 participants according to a predetermined statistical plan. DiaMedica will remain blinded to the data at the interim analysis.

8/10 17:00

DiaMedica CEO Says DM199 Promising for Ischemic Diseases

"With the recent positive interim results from Part 1a of our Phase 2 study evaluating DM199 in preeclampsia, we're eager to continue advancement of this promising candidate to address ischemic diseases in the second half of this year," said Rick Pauls, President and CEO of DiaMedica. "Preeclampsia, fetal growth restriction and stroke are areas with high unmet medical need due to the lack of approved treatment options, and we believe DM199 has the potential to provide a disease-modifying solution for patients suffering from these ischemic conditions. We look forward to sharing results of the recently completed first cohort of fetal growth restriction and initiating subsequent studies in the ongoing investigator-sponsored Phase 2, open label trial in these indications."

6/23 09:00

DiaMedica Initiates DM199 Clinical Trial

DiaMedica Therapeutics announced the dosing of the first two patients in an investigator-sponsored Phase 2 trial evaluating DM199 for the treatment of fetal growth restriction. This is the first clinical evaluation of DM199 in FGR. The open-label, single-arm study is designed to evaluate three dose levels of DM199 in up to 30 patients with early-onset FGR.

6/16 09:00

DiaMedica Receives FDA Feedback on DM199

DiaMedica Therapeutics announced that it has received a written response from the U.S. Food and Drug Administration, FDA, regarding the need for additional nonclinical reproductive toxicity data to support continued development of DM199 for the treatment of preeclampsia. DiaMedica believes, based on the FDA's feedback, that the previously completed rat reproductive toxicity study may be acceptable to support a U.S. investigational new drug, IND, application, provided that DiaMedica can demonstrate sufficient evidence of DM199 exposure and enzymatic activity throughout the previous completed rat study, as well as adequate pharmacologic effect in rats to support their use as an appropriate toxicology species. To address the FDA's request, DiaMedica is initiating a pharmacokinetic and pharmacologic activity study of DM199 in rats and is summarizing the recently completed study data intended to support the pharmacodynamic activity of DM199 in this species. Upon completion of the rat PK study, DiaMedica plans to submit the requested information to FDA for review.

5/20 08:40

DiaMedica Announces 75% Enrollment in ReMEDy2 Trial

DiaMedica Therapeutics announced that enrollment in its pivotal Phase 2/3 ReMEDy2 trial of DM199in patients with acute ischemic stroke, AIS, has reached 75% of the 200-patient threshold required to trigger the planned interim analysis. The Company reiterates its guidance regarding completion of the interim analysis by the end of 2026.

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