DiaMedica Reaches 75% Enrollment and Schedules DSMB Interim Analysis
DiaMedica has enrolled 150 of 200 patients (75%) in its pivotal Phase 2/3 ReMEDy2 trial of DM199 for acute ischemic stroke, triggering an independent DSMB interim analysis by year-end 2026. The adaptive study’s sample size could be re-estimated to range from 300 to 728 participants based on that review.
1. Enrollment Milestone Achieved
The pivotal Phase 2/3 ReMEDy2 trial of DM199 in acute ischemic stroke has enrolled 150 of the planned 200 participants, meeting the threshold required to trigger the interim analysis by the independent Data Safety Monitoring Board (DSMB).
2. Interim Analysis Details
The DSMB will conduct the interim review before the end of 2026 to determine whether to recommend a sample size re-estimation or to stop for futility, while the company remains blinded to specific efficacy data.
3. Adaptive Trial Design
ReMEDy2 is a randomized, double-blind, placebo-controlled study with a primary efficacy endpoint defined as the proportion of patients achieving a modified Rankin Score of 0 or 1 at Day 90, indicating excellent clinical outcome. The final enrollment could be adjusted between 300 and 728 patients based on the interim findings.
4. Global Site Activation
Approximately 70 clinical sites are active across the United States, Canada, the United Kingdom and Europe, with patient recruitment ongoing while the first 200 participants complete follow-up and the interim analysis is conducted.