DiaMedica Therapeutics Inc. (Nasdaq: DMAC) has announced updates to its ReMEDy2 Phase 2/3 trial for acute ischemic stroke (AIS) and its Q3 2024 financial results. The company has broadened the trial population to include patients not responding to thrombolytic treatment and increased the interim analysis sample size to 200 subjects. Top-line interim results are now expected in Q4 2025. DiaMedica's Preeclampsia Phase 2 trial received regulatory approval and dosed its first patient. The company's cash position stands at $50.2 million as of September 30, 2024, providing a cash runway into Q3 2026.
ReMEDy2 Trial Protocol Updates
DiaMedica has implemented key changes to the ReMEDy2 trial protocol following discussions with investigators, stroke experts, and its scientific advisory board. The trial population has been expanded to include patients who do not respond to thrombolytic treatment, specifically tissue plasminogen activator (tPA) or tenecteplase (TNK). These patients, defined as retaining a persistent neurologic deficit six or more hours after thrombolytic administration, are expected to show a strong treatment response with a low placebo response.
According to Dr. Lorianne Masuoka, DiaMedica’s Chief Medical Officer, "The inclusion of thrombolytic non-responders significantly expands the pool of eligible patients with potential for observing increased treatment responses." The company's prior ReMEDy1 Phase 2 stroke trial showed the highest response rate in the subgroup of patients who received tPA (n=20) prior to enrollment.
The interim analysis sample size has been increased to 200 subjects, up from the previously proposed 144 subjects. This modification aims to increase the precision of the algorithm used to determine the final overall sample size, potentially reducing the total number of participants required and, consequently, the overall trial timeline and cost. DiaMedica plans to submit an amended statistical analysis plan (SAP) to the FDA for confirmatory comments.
Clinical Trial Progress
DiaMedica continues to make progress with ReMEDy2 trial site activation activities. The majority of the company’s priority research sites in the United States have been activated. Approval from Health Canada has also been received to conduct the ReMEDy2 trial in Canada, with site activations expected by the end of the year.
Due to the increased sample size for the interim analysis, top-line interim results are now anticipated in Q4 2025, compared to the previous guidance of Summer 2025. Patient recruitment will continue while the first 200 participants complete their participation in the trial and the interim analysis is conducted.
Preeclampsia Phase 2 Trial
DiaMedica's DM199 is under development as a disease-modifying treatment for preeclampsia (PE). The drug's mechanism of action has the potential to lower blood pressure, enhance endothelial health, and improve perfusion to maternal organs and the placenta. Regulatory approval has been received from the South African Health Products Regulatory Authority (SAHPRA) to initiate an investigator-sponsored trial (IST) of DM199 in PE. The first patient has been enrolled in the Part 1A dose escalation portion of the Phase 2 study, with top-line results anticipated in the first half of 2025.
The Phase 2 IST is an open-label, single-center, single-arm, safety and pharmacodynamic, proof-of-concept study of DM199 for the treatment of PE, conducted at the Tygerberg Hospital, Cape Town, South Africa. Up to 90 women with PE, and potentially an additional 30 subjects with fetal growth restriction, may be evaluated. Key outcomes from Part 1 are safety, tolerability, identifying whether DM199 crosses the placental barrier, and changes in maternal systolic blood pressure (SBP) and uterine artery blood flow.
Financial Highlights
DiaMedica reported total cash, cash equivalents, and investments of $50.2 million as of September 30, 2024, with working capital of $46.5 million. Research and development (R&D) expenses increased to $5.0 million for the three months ended September 30, 2024, up from $3.3 million for the three months ended September 30, 2023. General and administrative (G&A) expenses were $1.9 million for each of the three-month periods ended September 30, 2024 and 2023. The company's cash runway extends into Q3 2026.
