Moleculin Biotech, Inc. has announced that 60% of the target enrollment for the first planned interim unblinding of its pivotal Phase 2B/3 “MIRACLE” study has been achieved, with 27 out of 45 subjects consenting to participate. This study evaluates Annamycin in combination with cytarabine for adult patients with relapsed or refractory acute myeloid leukemia (R/R AML). With recruitment ongoing as of November 4, 2025, the company anticipates completing treatment of these subjects by the first quarter of 2026, followed by initial data unblinding.
Walter Klemp, Chairman and CEO, expressed optimism regarding recruitment momentum, noting positive feedback from investigators across Europe and the U.S. Despite challenges such as bed shortages at some European sites, the study is progressing as planned, with early unblinding expected to provide critical insights into Annamycin’s efficacy and safety. The MIRACLE trial’s adaptive design aims to combine data from its Phase 2B and Phase 3 portions, potentially accelerating the path to approval for this promising therapy.
The trial is significant not only for its innovative approach but also for its potential to address unmet needs in AML treatment. Annamycin, which has received both Fast Track Status and Orphan Drug Designation from the FDA, is designed to overcome multidrug resistance and minimize cardiotoxicity associated with traditional anthracyclines. As the study progresses, the implications for AML treatment could be profound, offering new hope for patients facing this challenging disease.
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