Moleculin Biotech: Annamycin Shows Encouraging Remission Rates in AML Trial
Moleculin Biotech, Inc. announced that an abstract detailing data from its lead drug candidate, Annamycin, has been accepted for presentation at the 2026 American Society of Hematology (ASH) Annual Meeting. The abstract presents first interim results from the pivotal Phase 2/3 trial (MB-108) evaluating Annamycin in combination with cytarabine for patients with relapsed or refractory acute myeloid leukemia (AML). The interim analysis showed complete remission rates of 43% and 36% in the Annamycin treatment arms, compared to 12% in the placebo arm, with no observed cardiotoxicity. The independent Data Monitoring Committee recommended the study continue without amendment. The second interim analysis is anticipated in early 2027.
Key Highlights
- Moleculin Biotech announces abstract accepted for presentation at 2026 ASH Annual Meeting for lead drug candidate Annamycin.
- Abstract highlights data from pivotal Phase 2/3 trial (MB-108) evaluating Annamycin in combination with cytarabine for relapsed/refractory AML.
- First interim analysis of 45 randomized patients showed complete remission rates of 43% and 36% in Annamycin arms vs. 12% in placebo arm.
- No signs of cardiotoxicity observed in Annamycin treatment arms through data cutoff.
- Independent Data Monitoring Committee recommended study continuation without amendment.
- Second interim analysis of the MIRACLE Trial (MB-108) is expected in early 2027.
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