$MBRXJul 31, 2026, 8:10 AM ETAI processed
MBRX MIRACLE interim blinded CRc 37% overall and in venetoclax-failed subgroup; enrollment 74/90
AI Summary
Moleculin (MBRX) reported preliminary blinded Part A results from the Phase 2/3 MIRACLE trial: among 62 evaluable patients AnnAraC (Annamycin + cytarabine) showed a blinded CR of 24% and CRc of 37%, and the 30-patient subgroup who failed first-line venetoclax had similar rates (CR 23%, CRc 37%) versus published salvage remission benchmarks of ~13%. The analysis is still blinded and includes control-arm patients; enrollment is 74/90 with final Part A treatment expected Sept 2026 and unblinded Part A results due Dec 2026–Feb 2027, and no cardiotoxicity signal has been observed to date.
Positives
- Preliminary blinded CRc of 37% (n=62) for Annamycin+cytarabine in Part A
- Venetoclax-failure subgroup (n=30) showed same blinded CRc 37%, substantially above ~13% published salvage rate
- No evidence of cardiotoxicity reported and enrollment nearing completion (74/90)
Negatives
- Results are preliminary and still blinded (include control-arm subjects) so expected to understate unblinded Annamycin-arm efficacy
- Venetoclax-failure subgroup is small (30 patients) and the trial is not powered for subgroup comparisons
- Future milestones and timeline depend on completing enrollment and securing additional financing