$MBRXJun 30, 2026, 8:30 AM ETAI processed
Moleculin Annamycin shows ~3x CR vs control in Phase 2/3 MIRACLE interim (n=45)
AI Summary
Moleculin reported unblinded interim results from the first 45 patients in Part A of the Phase 2/3 MIRACLE trial: both Annamycin arms achieved complete remission rates of 43% and 36% versus 12% for the HiDAC control, and CRc of 50% and 57% versus 29% for control — all measured after a single treatment cycle. The trial's Independent Data Monitoring Committee found a strong numeric trend favoring Annamycin, recommended continuing the study without dropping either dose, and Part A is ~74% enrolled (67/90) with the selected dose to carry forward into the pivotal portion.
Positives
- Both Annamycin dose arms outperformed control on primary endpoint (CR 43%/36% vs 12%).
- Composite CRc also favored Annamycin (50%/57% vs 29% control).
- iDMC unanimously recommended continuing the trial and retaining both dose arms; Part A ~74% enrolled.
Negatives
- Interim dataset is small (n=45) and did not reach formal statistical significance at this early look.
- Reported responses are after a single cycle, whereas historical benchmarks often permit multiple cycles.
- Company states it will require significant additional financing to complete trials (no commitments yet).