Moleculin Reports Positive Interim Phase 2/3 Data for Annamycin in AML Trial

Moleculin Biotech, Inc. (MBRX) announced positive preliminary efficacy results from its pivotal Phase 2/3 MIRACLE trial for Annamycin in treating relapsed or refractory acute myeloid leukemia (R/R AML). The interim analysis of the first 45 patients showed that both Annamycin treatment arms significantly outperformed the control arm on the primary endpoint of complete remission.

Key Details

• Primary Endpoint (Complete Remission): The two Annamycin treatment arms demonstrated complete remission (CR) rates of 43% and 36%, compared to 12% for the control arm.
• Composite Remission: Composite complete remission (CRc) rates reached 50% and 57% in the Annamycin arms, versus 29% for the control group.
• Trial Status: The Independent Data Monitoring Committee recommended continuing the trial as planned. Enrollment for Part A of the study is ongoing, with 67 of a targeted 90 patients enrolled.