Moleculin Biotech, Inc. announced on September 29, 2026, that it has completed and closed enrollment 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).
According to the filing, 89 subjects have been enrolled in Part A, with one additional subject currently in screening. The company stated that it remains on track for a comprehensive data readout of Part A in the first quarter of 2027.
The press release accompanying the filing noted that the rapid pace of enrollment reflects strong engagement from investigators and clinical sites. The company expects the expanded Part A dataset to provide insight into the potential efficacy of AnnAraC across subjects who have relapsed from or are refractory to different first-line treatment approaches, including intensive 7+3 chemotherapy and venetoclax-based regimens.
Walter Klemp, Chairman and Chief Executive Officer of Moleculin, commented on the milestone, stating that the completion of enrollment reflects the execution of the team and investigators. He noted that the company is entering a potentially defining period for the MIRACLE program.
The MIRACLE trial is a randomized, double-blind study comparing two different doses of Annamycin plus cytarabine to a control arm of cytarabine plus placebo. As specified by the protocol, remission rates for all arms reflect outcomes measured after only a single cycle of therapy.
The company highlighted that the composition of the final Part A population is expected to approximate a 50/50 split between subjects who were previously treated with intensive 7+3 regimens and those treated with venetoclax-based regimens. The company also noted that it continues to see a lack of cardiotoxicity in the blinded data of the trial.
