Clinical TrialJul 31, 2026, 08:02 AM
Moleculin's Annamycin MIRACLE Trial Shows 37% Blinded CRc in R/R AML
AI Summary
Moleculin Biotech announced updated preliminary blinded results from Part A of its pivotal Phase 2/3 MIRACLE trial for Annamycin in relapsed or refractory acute myeloid leukemia (R/R AML). With 62 evaluable subjects, the preliminary blinded composite complete remission (CRc) rate was 37%, including 37% in patients who previously failed venetoclax-based regimens, significantly higher than published salvage rates of 13%. The trial continues to show no evidence of cardiotoxicity, and enrollment has reached 74 of 90 patients, with unblinded Part A results expected by early 2027.
Key Highlights
- Preliminary blinded CRc rate of 37% (n=62) for Annamycin in R/R AML.
- Blinded CRc rate of 37% in 30 venetoclax-failed patients, compared to 13% published rates.
- Preliminary blinded CR rate of 24% (n=62) and 23% in venetoclax-failed subgroup.
- No evidence of cardiotoxicity observed in the trial.
- Enrollment reached 74 of 90 patients for Part A of the MIRACLE trial.
- Final Part A treatment expected in September 2026.
- Comprehensive unblinded Part A results anticipated December 2026–February 2027.
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