Moleculin Biotech announced positive interim results from its pivotal Phase 2/3 trial (MB-108) evaluating its lead drug candidate, Annamycin, for relapsed or refractory acute myeloid leukemia (AML). The data has been accepted for presentation at the 2026 American Society of Hematology (ASH) Annual Meeting.
Key Details
- Trial Results: The first interim analysis of 45 patients showed complete remission rates of 43% and 36% in the two Annamycin treatment arms, compared to 12% in the placebo arm.
- Safety & Outlook: No signs of cardiotoxicity were observed. An independent data monitoring committee recommended the study continue without modification, with a second interim analysis expected in early 2027.
- Upcoming Presentation: The data will be presented at the ASH Annual Meeting in New Orleans, taking place from December 12-15, 2026.