Moleculin Completes Dosing Patients in Part A of Pivotal MIRACLE Trial; Comprehensive Data Readout on Track for Q1 2027
Moleculin Biotech completed dosing of all 90 patients in Part A of its pivotal Phase 2/3 MIRACLE trial of Annamycin plus cytarabine (AnnAraC) in relapsed/refractory acute myeloid leukemia. The company remains on track for a comprehensive Part A data readout in Q1 2027, which will support selection of the Annamycin dose for Part B of the trial. The final Part A population is expected to split roughly 50/50 between patients who failed 7+3 chemotherapy and those who failed venetoclax-based regimens, versus a 70/30 split in the first 45 subjects.
Key figures
- Drug Name
- Annamycin (AnnAraC, naxtarubicin)
- Phase Of Trial
- Phase 2/3 (pivotal)
- Data readout
- Q1 2027
- Part a patients
- 90
- Population split
- approximately 50/50 between 7+3 chemotherapy failures and venetoclax-based regimen failures
- Trial identifier
- NCT06788756
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