Moleculin Biotech Nears First Unblinding Milestone in Pivotal Phase 3 AML Trial
Moleculin Biotech Inc. has announced an update on the enrollment progress of its pivotal Phase 2B/3 "MIRACLE" clinical trial evaluating Annamycin in combination with cytarabine for adult patients with relapsed or refractory acute myeloid leukemia (AML). As of November 4, 2025, 60% of the targeted 45 subjects for the first planned interim unblinding have consented to participate. The company anticipates completing treatment of these initial 45 patients in the first quarter of 2026, with initial unblinded data expected to be released thereafter. Additional subjects continue to be identified, and the second unblinding is anticipated in the first half of 2026. The trial is being conducted across sites in five countries. Results from this study have not yet been presented.
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