DiaMedica Therapeutics announced that it has reached approximately 75% enrollment in its ReMEDy2 Phase 2/3 acute ischemic stroke trial, marking a key development milestone in the study.
DiaMedica Therapeutics Inc. announced a significant development in its late-stage clinical program for acute ischemic stroke, reporting that enrollment in its pivotal Phase 2/3 ReMEDy2 trial evaluating DM199 (rinvecalinase alfa) has reached 75% of the 200-patient threshold required to initiate the study’s planned interim analysis. The company confirmed that it continues to expect the interim analysis to be completed by the end of 2026, keeping the program on track for a key regulatory and development milestone.
The ReMEDy2 study represents one of DiaMedica’s most important clinical programs, focusing on patients suffering from acute ischemic stroke (AIS), a leading cause of disability and death worldwide. DM199, also known as rinvecalinase alfa, is an investigational therapy designed to target underlying vascular and inflammatory pathways that contribute to ischemic brain injury. By modulating these biological mechanisms, the company aims to improve functional recovery outcomes in stroke patients, an area where therapeutic advancement has been historically limited.
According to the company, reaching 75% enrollment toward the interim analysis trigger reflects strong momentum across its global clinical site network. The trial is actively enrolling patients across approximately 70 activated clinical sites located in the United States, Canada, the United Kingdom, and several European countries. This broad geographic footprint is intended to support timely recruitment while ensuring a diverse patient population, which can improve the robustness and generalizability of trial results.
The ReMEDy2 trial (ClinicalTrials.gov identifier: NCT05065216) is designed as an adaptive, randomized, double-blind, placebo-controlled Phase 2/3 study. Its adaptive structure allows for pre-planned modifications based on interim data, with the goal of optimizing statistical power while maintaining scientific rigor and regulatory integrity. The trial evaluates the efficacy and safety of DM199 in patients who have experienced an acute ischemic stroke, with treatment administered in addition to standard of care.
The primary efficacy endpoint of the study is stroke recovery as measured by the proportion of patients achieving a modified Rankin Scale (mRS) score of 0 or 1 at Day 90. The mRS is a widely used clinical scale that ranges from 0 to 6, where lower scores indicate better functional outcomes. A score of 0 reflects no symptoms at all, while a score of 1 indicates no significant disability despite symptoms. Achieving this endpoint is considered indicative of an excellent recovery outcome following stroke.
The study protocol includes a pre-specified interim analysis that will be conducted once the first 200 participants have been enrolled and followed through the required assessment period. At that point, an independent Data Safety Monitoring Board (DSMB) will review the accumulated data. The DSMB will be responsible for determining whether a sample size re-estimation is necessary to ensure that the trial remains adequately powered to detect a meaningful treatment effect.
Importantly, the interim analysis is also designed to protect the integrity of the study. It will assess whether adjustments to the total sample size are needed, with the final enrollment target expected to fall within a range of 300 to 728 patients depending on the findings. The DSMB will also evaluate whether there are any concerns related to safety or futility, although DiaMedica emphasized that the company itself will remain fully blinded to the interim results to avoid bias in ongoing trial conduct.
The adaptive nature of the ReMEDy2 trial reflects modern clinical development strategies increasingly used in late-stage biopharmaceutical programs. By incorporating an interim analysis with the potential for sample size re-estimation, the study aims to balance efficiency with statistical rigor. This approach allows researchers to make data-driven adjustments while preserving the validity of final efficacy outcomes, which is particularly important in complex neurological conditions such as stroke.
Management at DiaMedica emphasized that the current enrollment milestone represents meaningful progress in a high-need therapeutic area. Stroke remains one of the leading causes of long-term disability globally, and despite significant research efforts, treatment options that meaningfully improve post-stroke functional recovery remain limited. As such, the company believes that DM199 could potentially address a major unmet medical need if clinical benefit is demonstrated in the ongoing study.
“Reaching 75% enrollment toward our interim analysis threshold is a meaningful milestone that reflects the dedication of our clinical sites and the urgency of finding new treatments for stroke patients,” said Dr. Julie Krop, Chief Medical Officer of DiaMedica Therapeutics Inc.. “We now have approximately 70 sites activated. Based on projected enrollment rates across our network of centers in the United States, Canada, the United Kingdom and Europe, we anticipate completing the interim analysis before year-end. This analysis will be an important inflection point for the program, providing critical data to guide the path forward for DM199 in acute ischemic stroke.”
Her comments highlight both the operational progress of the study and the strategic importance of the upcoming interim analysis. With enrollment continuing across multiple international regions, DiaMedica is working to ensure that the trial progresses efficiently while maintaining strict adherence to clinical protocols and regulatory requirements.
DM199 (rinvecalinase alfa), the investigational therapy under evaluation, is central to DiaMedica’s broader pipeline strategy, which focuses on vascular and kidney-related diseases with significant unmet medical needs. In acute ischemic stroke, the therapy is being investigated for its potential to improve blood flow regulation and reduce secondary injury mechanisms that often worsen outcomes after the initial ischemic event.
The interim analysis expected by the end of 2026 is likely to serve as a major inflection point for the program. If the DSMB recommends a sample size adjustment, the trial could expand to better capture treatment effects, potentially increasing the likelihood of achieving statistically significant outcomes. Alternatively, if the data suggest sufficient power or lack of efficacy, the program could proceed or be re-evaluated accordingly.
For investors and clinical stakeholders, the milestone underscores steady progress in a complex and competitive neurological drug development landscape. Acute ischemic stroke remains an area of high unmet need, and clinical-stage companies such as DiaMedica are increasingly relying on adaptive trial designs to improve efficiency and decision-making in late-stage development.
Overall, the achievement of 75% enrollment toward the interim analysis threshold marks a critical step forward for DiaMedica’s ReMEDy2 program. With global site activation expanding, enrollment momentum building, and a structured adaptive design in place, the company is positioning DM199 for a potentially pivotal period of clinical evaluation over the next several years.
About DM199
DM199 is a recombinant form of human tissue kallikrein-1 (KLK1), a serine protease involved in the regulation of local blood flow and inflammatory responses. DiaMedica believes DM199 has the potential to improve neurological outcomes in patients with acute ischemic stroke by promoting perfusion and neuroprotection in ischemic tissue.
About DiaMedica Therapeutics Inc.
DiaMedica Therapeutics Inc. is a clinical stage biopharmaceutical company committed to improving the lives of people suffering from serious ischemic diseases with a focus on preeclampsia, fetal growth restriction, and acute ischemic stroke. DiaMedica’s lead candidate DM199 is the first pharmaceutically active recombinant (synthetic) form of the KLK1 protein, an established therapeutic modality in Asia for the treatment of acute ischemic stroke, preeclampsia and other vascular diseases.
