other material
confidence high
sentiment positive
materiality 0.65
Moleculin Biotech completes Part A enrollment in Phase 2/3 MIRACLE trial with 89 R/R AML subjects
Moleculin Biotech, Inc.
- Part A of the pivotal Phase 2/3 MIRACLE trial closed enrollment with 89 subjects enrolled and one additional subject in screening.
- Moleculin remains on track for a comprehensive Part A data readout in Q1 2027.
- The full Part A population is expected to be approximately 50/50 between 1L 7+3 and venetoclax-based regimens, versus a 70/30 split in the first 45 subjects.
- CEO Walter Klemp said the Q1 2027 readout will be deeper in data than the first interim n45 readout.
- The company continues to see no cardiotoxicity in blinded MIRACLE data; AnnAraC combines Annamycin with cytarabine.