Moleculin reports 43% complete remission rate in Annamycin arm of Phase 2/3 AML trial
MBRX•Moleculin Biotech said its Phase 2/3 trial found a 43% complete remission rate in the Annamycin arm, higher than placebo in patients with relapsed or refractory acute myeloid leukemia.
1. Trial results
The pivotal Phase 2/3 study found higher complete remission rates with Annamycin plus cytarabine than placebo. No signs of cardiotoxicity were observed through the data cutoff, and an independent monitoring committee recommended continuing the trial without changes, retaining all three treatment arms. A second interim analysis is expected in early 2027; Moleculin plans independent cardiac safety reviews at that analysis.
2. Presentation planned
Moleculin Biotech will present interim trial results at the ASH annual meeting in New Orleans, Dec. 12-15, 2026. The company said a successful trial could support a New Drug Application submission.
