Clinical TrialJun 30, 2026, 08:33 AM
Moleculin Annamycin Phase 2/3 CR Rates Up to 43% vs 12% Control
AI Summary
Moleculin Biotech announced positive preliminary unblinded efficacy results from the first 45 patients in Part A of its pivotal Phase 2/3 MIRACLE trial for Annamycin in relapsed or refractory acute myeloid leukemia (R/R AML). Both Annamycin treatment arms demonstrated favorable efficacy trends, with complete remission (CR) rates of 43% and 36% compared to 12% for the control arm. Composite complete remission (CRc) reached 50% and 57% in the Annamycin arms versus 29% for control, leading the iDMC to recommend continuing the trial.
Key Highlights
- Annamycin CR rates: 43% (190 mg/m²) and 36% (230 mg/m²) vs. 12% for control.
- Annamycin composite CR (CRc) rates: 50% (190 mg/m²) and 57% (230 mg/m²) vs. 29% for control.
- Results from first 45 patients in Part A of pivotal Phase 2/3 MIRACLE trial for R/R AML.
- Independent Data Monitoring Committee (iDMC) recommended continuing the trial.
- Trial remains fully powered at 80% for final analysis of approximately 282 subjects.
- 67 of 90 target patients (74%) enrolled in Part A of the study.
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