Moleculin Biotech’s Annamycin Shows 43% and 36% Complete Remission Rates
MBRX•In the first 45 patients of Part A in the pivotal Phase 2/3 MIRACLE trial, Moleculin Biotech’s Annamycin arms achieved complete remission rates of 43% and 36% versus 12% for the control arm. Composite complete remission reached 50% and 57% for the two dose cohorts compared to 29% for control.
1. Interim Phase 2/3 Efficacy
Interim analysis of 45 intent-to-treat patients in Part A of the MIRACLE trial showed Annamycin at 190 and 230 mg/m² plus high-dose cytarabine achieved CR rates of 43% and 36% versus 12% for the control arm, with composite CRc of 50% and 57% versus 29% control.
2. Trial Design and Enrollment
The randomized, double-blind, placebo-controlled Phase 2/3 study is evaluating two Annamycin dose arms against a high-dose cytarabine control in relapsed/refractory AML. Enrollment has reached 67 of the 90 planned patients for Part A, representing 74% of the target for dose optimization.
3. Next Steps and Implications
The independent data monitoring committee unanimously recommended continuing both experimental arms into Part B, carrying forward efficacy data. With full powering to detect 20% vs. 35% CR rates at final analysis, positive trends may support Annamycin’s advancement and potential new AML treatment option.
