Moleculin Announces 60% Consent Rate Among First 45 Participants in Pivotal “MIRACLE” Phase 3 AML Trial

MIRACLE Study Update: Moleculin Biotech reports that 60% of the target enrollment for the pivotal Phase 2B/3 MIRACLE study of Annamycin in combination with cytarabine for treating relapsed or refractory acute myeloid leukemia (AML) has been achieved, with treatment of the first 45 patients expected to complete by Q1 2026.

Positive Recruitment Momentum: The company is encouraged by the recruitment progress and response activity tracking within expected ranges, despite some enrollment challenges in Europe due to bed shortages.

Trial Design and Unblinding: The MIRACLE trial is designed to combine data from its Phase 2B and Phase 3 portions, with the first unblinding of data anticipated after treating 45 subjects, followed by a second unblinding expected in the first half of 2026.

Annamycin's Potential: Annamycin, which has received Fast Track Status and Orphan Drug Designation from the FDA, aims to provide a safer and more effective treatment option for AML, with ongoing development supported by a robust pipeline of therapeutic candidates.