Moleculin Completes Patient Dosing in Pivotal AML Trial, Data Readout Expected Q1 2027

Moleculin Biotech (MBRX) announced it has completed patient dosing in Part A of its pivotal Phase 2/3 MIRACLE trial. The study is evaluating Annamycin in combination with cytarabine (AnnAraC) for the treatment of adults with relapsed or refractory acute myeloid leukemia (R/R AML).

Key Details

• Trial & Milestone: Dosing has been completed for the 90-patient Part A portion of the pivotal Phase 2/3 MIRACLE trial.
• Indication & Drug: The trial evaluates the safety and efficacy of Annamycin in combination with cytarabine (AnnAraC) in adults with relapsed or refractory acute myeloid leukemia (R/R AML).
• Next Steps: The company is on track to report comprehensive data from Part A in the first quarter of 2027. This data will be used to select the optimal Annamycin dose for Part B of the trial.