Clinical TrialJul 31, 2026, 08:13 AM
Moleculin Annamycin MIRACLE Trial: 37% CRc in R/R AML, No Cardiotoxicity
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). The trial showed a preliminary blinded composite complete remission (CRc) rate of 37% (n=62), with an identical 37% CRc rate in patients who previously failed venetoclax therapy, significantly exceeding published salvage rates. The company also reported no evidence of cardiotoxicity, differentiating Annamycin from conventional anthracyclines. Enrollment is at 74 of 90 patients, with comprehensive unblinded Part A results expected between December 2026 and February 2027.
Key Highlights
- Preliminary blinded composite complete remission (CRc) rate of 37% (n=62) in R/R AML patients.
- CRc rate of 37% observed in 30 patients who had failed prior venetoclax therapy.
- This 37% CRc is 3X higher than published salvage remission rates of approximately 13% post-venetoclax failure.
- No evidence of cardiotoxicity continues to differentiate Annamycin from conventional anthracyclines.
- Enrollment for Part A of the MIRACLE trial reached 74 of 90 patients.
- Final Part A treatment is expected to be completed in September 2026.
- Comprehensive unblinded Part A results are anticipated between December 2026 and February 2027.
- Blinded CRc has remained within a narrow 37%-40% band across three successive analyses.
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