Moleculin Biotech, Inc. announced it has completed and closed patient enrollment for Part A of its pivotal Phase 2/3 MIRACLE trial. The study is evaluating its drug candidate Annamycin for the treatment of relapsed or refractory acute myeloid leukemia (R/R AML). This milestone keeps the program on track for a comprehensive data readout in the first quarter of 2027.

Key Details

  • Trial: Part A of the pivotal Phase 2/3 MIRACLE trial, evaluating Annamycin in combination with cytarabine (AnnAraC).
  • Enrollment: Enrollment is complete with 89 subjects, with two additional subjects in screening.
  • Timeline: The company expects a comprehensive data readout for Part A of the trial in Q1 2027.
  • Patient Population: The final dataset is expected to include an approximate 50/50 split between subjects previously treated with intensive 7+3 chemotherapy and those treated with venetoclax-based regimens.