Moleculin Announces Completion of Treatment for the 45 Patients in Pivotal “MIRACLE” Phase 3 AML Trial on Pace for Q1 2026

Core Insights - The company has reported an increase in enrollment for the MIRACLE trial, reaching 78% of the target number of subjects for the first interim unblinding, up from 60% in November [1][2] - The trial aims to evaluate Annamycin in combination with cytarabine for treating adult patients with relapsed or refractory acute myeloid leukemia (AML) [1][9] - The first unblinding is expected to occur in the first quarter of 2026, with a target of 45 subjects [1][4] Enrollment and Trial Progress - As of December 3, 2025, the company has consented subjects from seven countries, indicating a diverse patient population [4] - The company anticipates completing treatment of the first 45 subjects by the first quarter of 2026 and aims to finish Part A of the trial with up to 90 patients in the first half of 2026 [4][2] - The trial design allows for unblinding of preliminary efficacy data at 45 subjects, with a focus on complete remission as a primary endpoint [3] Annamycin's Potential and Designation - Annamycin has received Fast Track Status and Orphan Drug Designation from the FDA for treating relapsed or refractory AML, as well as Orphan Drug Designation from the EMA [6][7] - The drug is designed to avoid multidrug resistance mechanisms and lacks the cardiotoxicity associated with current anthracyclines [8] - The company believes Annamycin could provide a safer and more effective treatment option for AML patients [2]