Moleculin Biotech, Inc. (Nasdaq: MBRX) reported updated preliminary blinded interim results from Part A of its pivotal Phase 2/3 MIRACLE trial, evaluating Annamycin in combination with cytarabine for the treatment of relapsed or refractory acute myeloid leukemia (R/R AML).

Among 62 evaluable subjects, the preliminary blinded complete remission (CR) rate was 24% and the composite complete remission (CRc) rate was 37%. Of those 62 subjects, 30, or 48%, had previously received a venetoclax-based regimen. Within that subgroup, the blinded CR and CRc rates were 23% and 37%, respectively. A published retrospective analysis reported a salvage remission rate of approximately 13% and median overall survival of approximately 2.4 months following first-line venetoclax failure, though that study is not a controlled comparison to the MIRACLE trial.

Because the current analysis remains blinded and includes subjects randomized to the control arm, these figures are expected to be lower than the unblinded Annamycin-arm results reported at a June 2026 interim analysis, in which CRc reached 50% and 57% in the two Annamycin arms versus 29% for control among 45 evaluable subjects. The two sets of figures are not directly comparable.

The company reported no evidence of cardiotoxicity based on ejection fractions and adverse events across the trial population. Annamycin has FDA Fast Track Status and Orphan Drug Designation for R/R AML.

Enrollment stands at 74 of 90 subjects. The company expects to treat the 90th subject in September 2026, with comprehensive unblinded Part A results anticipated between December 2026 and February 2027. The data reported were as of July 18, 2026, according to the company's statement.