Moleculin Biotech (MBRX) announced updates to its active site status and recruitment for its pivotal Phase 2B/3, multi-center, randomized, double-blind, placebo-controlled, adaptive design study of Annamycin in combination with cytarabine for the treatment of adult patients with acute myeloid leukemia who are refractory to or relapsed after induction therapy. This Phase 3 “MIRACLE” trial is a global approval trial, including sites in the US, Europe and the Middle East. To advance this trial to recruiting the 45th subject in Q4 2025 for its first unblinding for early data insights into the trial’s efficacy and safety endpoints, the Company has the following expectations for September: Global Expansion: Expanding recruiting beyond Ukraine to include Spain, Georgia, Poland, Romania, Italy, Lithuania, and the US; Site Expansion: Adding 8 new active sites by the end of September, increasing the total to 20 sites recruiting; Recruitment Goals: Treating, enrolling, or screening a total of 20 subjects by the end of September; and Data Insights: Setting a solid footprint to recruit the 45th subject in Q4 2025, allowing for unblinded preliminary data assessment regarding efficacy and safety upon data lock.
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