Moleculin Hits 45 Subject Enrollment Milestone, Triggering Final Countdown to Mid-2026 MIRACLE Trial Data Readout

Core Insights - Moleculin Biotech has enrolled the 45th subject in its pivotal Phase 2B/3 MIRACLE trial, evaluating Annamycin in combination with cytarabine for treating relapsed or refractory acute myeloid leukemia (R/R AML), marking a significant milestone for the company [1][2] - The upcoming interim data unblinding is expected in mid-2026 and is viewed as a potential inflection point for the company, with preliminary results indicating a 40% remission rate among the first 30 patients [2][3] Trial Progress - The MIRACLE trial is designed to evaluate AnnAraC across eight countries, with an initial dataset expected to include approximately 30 patients treated with AnnAraC and 15 patients in the control arm [2][4] - The trial's adaptive design aims to support a streamlined global registration pathway, integrating Phase 2B data into the Phase 3 portion, in line with regulatory guidance [4] Efficacy and Safety - Preliminary results from the trial show a composite complete remission rate of 40%, with 30% achieving complete remission and 10% achieving complete remission with partial hematologic recovery, despite many patients having previously failed venetoclax-based therapies [3][5] - The absence of cardiotoxicity in over 100 patients treated to date is a notable achievement for the company [2][5] Future Outlook - The company is advancing toward a total enrollment of 90 subjects, with the completion of Part A of the MIRACLE trial expected in Q3 2026 [2][4] - The successful outcomes from the trial could lead to a potential accelerated approval pathway based on the primary endpoint of complete remission [4][5]