Clinical TrialMay 13, 2026, 08:07 AM
Moleculin Nears MIRACLE Trial Unblinding; Blinded Data Outperforms Benchmarks
AI Summary
Moleculin Biotech announced it is nearing the first unblinding of data from its pivotal Phase 2B/3 MIRACLE trial for Annamycin in relapsed or refractory acute myeloid leukemia (R/R AML), expected before June 30, 2026. Preliminary blinded data for the first 45 subjects show a composite complete remission rate (CRc) exceeding 40% and a complete remission (CR) rate of approximately 30%. These results significantly outperform historical CR rates of 17-18% for cytarabine alone, suggesting a substantial advancement in AML treatment. The company continues to recruit for Part A, with 56 subjects enrolled towards a target of 90 in Q3 2026.
Key Highlights
- First unblinding of MIRACLE trial data expected before June 30, 2026.
- Preliminary blinded composite complete remission rate (CRc) for first 45 subjects exceeds 40%.
- Preliminary blinded complete remission (CR) rate for first 45 subjects approximates 30%.
- These rates represent approximately 67% improvement vs. historical standard of care (17-18%).
- 56 subjects recruited to date in MIRACLE trial, 62% of Part A target.
- Target of 90 subjects in Part A expected to be fully recruited in Q3 2026.
- Annamycin has Fast Track Status and Orphan Drug Designation from FDA for R/R AML.
- Annamycin has composition of matter patent protection through 2040, potentially extendable to 2045.