Moleculin Biotech Completes Enrollment in Part A of Phase 2/3 R/R AML MIRACLE Trial, Keeping Program on Track for Q1 2027 Data Readout
Moleculin Biotech completed and closed enrollment in Part A of its pivotal Phase 2/3 MIRACLE trial, with 89 subjects enrolled evaluating Annamycin plus cytarabine (AnnAraC) in relapsed/refractory AML. The company remains on track for a comprehensive Part A data readout in Q1 2027, which will also support dose selection for Part B of the trial. Management estimates the Part A population at roughly a 50/50 split between 'fit' and 'unfit' subjects — a more challenging mix than the first 45 subjects — and reports continued absence of cardiotoxicity in blinded data.
Key figures
- Drug Name
- Annamycin (naxtarubicin) / AnnAraC
- Phase Of Trial
- Phase 2/3
- Trial id
- NCT06788756
- Data readout
- Q1 2027
- Subjects enrolled
- 89
- First 45 subject split
- roughly 70/30 fit/unfit
- Fit unfit split expected
- approximately 50/50
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