Clinical TrialJun 4, 2026, 08:32 AM
Moleculin Biotech completes enrollment for Annamycin trial data unblinding
AI Summary
Moleculin Biotech, Inc. announced that the 45th subject has been enrolled in its pivotal Phase 2B/3 MIRACLE trial, evaluating Annamycin in combination with cytarabine (AnnAraC) for relapsed or refractory acute myeloid leukemia (R/R AML). This milestone triggers the final phase of preparation for the trial's interim 45-subject data unblinding, which is expected in mid-2026. The company views this as a potentially defining inflection point for Annamycin's development, believing the pathway towards potential approval for AML is substantially de-risked.
Key Highlights
- Moleculin Biotech enrolled the 45th subject in its pivotal Phase 2B/3 MIRACLE trial for Annamycin.
- The trial evaluates Annamycin in combination with cytarabine (AnnAraC) for relapsed or refractory acute myeloid leukemia (R/R AML).
- This enrollment milestone triggers the final phase of preparation for the interim 45-subject data unblinding.
- The interim data unblinding is on track for mid-2026, representing a potentially defining inflection point.
- Annamycin is a next-generation anthracycline designed to avoid multidrug resistance and cardiotoxicity.
- The company believes the development pathway for Annamycin in AML is substantially de-risked.
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