Moleculin Biotech, Inc. (Nasdaq: MBRX) announced on October 30, 2026, that dosing has been completed in Part A of its pivotal Phase 2/3 MIRACLE trial. The trial is evaluating Annamycin in combination with cytarabine, referred to as AnnAraC, for the treatment of adults with relapsed or refractory acute myeloid leukemia (R/R AML).
The Company stated that it remains on track to report comprehensive Part A data in the first quarter of 2027. The Part A population consists of 90 patients and is fully treated, randomized, and double-blind. The trial compares two different doses of Annamycin plus cytarabine against a control arm of cytarabine plus placebo, with all arms utilizing only a single cycle of therapy.
According to the filing, the final Part A population is expected to reflect an approximately 50/50 split between patients who failed intensive 7+3 chemotherapy and those who failed venetoclax-based regimens. The Company noted that the analysis will focus on remission rates measured after only one cycle, as the historical benchmarks referenced in the protocol permitted multiple cycles of treatment.
The Company highlighted that the continued absence of cardiotoxicity has been observed in blinded interim data. The data readout in the first quarter of 2027 is expected to provide insights into efficacy and safety across the randomized population and support the selection of the optimal Annamycin dose for advancement into Part B of the trial.
