Moleculin Biotech announced updated preliminary blinded results from Part A of its pivotal Phase 2/3 MIRACLE trial of Annamycin for treating relapsed or refractory acute myeloid leukemia (R/R AML). The data shows a 37% composite complete remission rate in a difficult-to-treat patient population.
Key Details
- Efficacy Data: With 62 evaluable subjects, the preliminary blinded complete remission (CR) rate was 24% and the composite complete remission (CRc) rate was 37%.
- Venetoclax-Failed Subgroup: In a subgroup of 30 patients who previously failed venetoclax-based therapy, the CRc rate was also 37%, notably higher than published salvage rates of approximately 13% for this population.
- Trial Progress & Timeline: Enrollment for Part A of the trial has reached 74 of 90 patients. The company expects to announce comprehensive unblinded Part A results between December 2026 and February 2027.
- Safety Profile: The company continues to observe no evidence of cardiotoxicity, a key differentiating safety feature for Annamycin compared to conventional anthracyclines.