Moleculin completes dosing in 90-patient leukemia trial
+1 new source since this summary was written
Moleculin Biotech completed dosing in Part A of its Phase 2/3 MIRACLE trial testing Annamycin plus cytarabine in adults with relapsed or refractory acute myeloid leukemia. The randomized, double-blind Part A enrolled 90 patients across two Annamycin dose arms and a cytarabine-plus-placebo control arm. Moleculin expects comprehensive data in Q1 2027, which will support selection of the Annamycin dose for Part B.
Why it matters
The Q1 2027 readout is the next stated decision point for dose selection and analysis of efficacy and safety across the completed Part A population. The milestone advances Moleculin's pivotal trial but does not yet provide clinical efficacy results.
Key facts
- 1Part A dosing was completed in a randomized, double-blind population of 90 patients. stocktitan.net
- 2The trial is evaluating Annamycin with cytarabine in adults with relapsed or refractory acute myeloid leukemia. stocktitan.net
- 3Moleculin expects to report comprehensive Part A data in Q1 2027. stocktitan.net
- 4The final Part A population is expected to have an approximately 50/50 split between patients previously treated with intensive 7+3 chemotherapy and venetoclax-based regimens, versus an approximately 70/30 split among the first 45 subjects. stocktitan.net
- 5Part A compares two Annamycin doses plus cytarabine with cytarabine plus placebo. rttnews.com
- 6The company said blinded interim data continued to show no evidence of cardiotoxicity. rttnews.com
Summary written by AlphAI AI Desk from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.