Clinical TrialMay 29, 2026, 08:22 AM
Moleculin Annamycin Shows Best-in-Class Cardiac Safety in Trials
AI Summary
Moleculin Biotech announced new data at ASCO 2026, reinforcing the differentiated cardiac safety profile of its lead drug candidate, Annamycin. A pooled analysis across five clinical trials demonstrated no detectable cardiotoxicity, even at cumulative exposure levels substantially exceeding traditional anthracycline dose limitations. This data was independently reviewed by Cleveland Clinic cardiology specialists, providing external validation. The company believes this strengthens the rationale for its ongoing pivotal Phase 2b/3 MIRACLE trial for relapsed or refractory AML, with unblinding from the first 45 patients expected in June 2026.
Key Highlights
- Annamycin showed no detectable cardiotoxicity across five clinical trials, despite high cumulative anthracycline exposure.
- Median cumulative Annamycin dose was 660 mg/m², with exposure up to 2,970 mg/m².
- No statistically significant difference in LVEF from baseline to final assessment (mean difference: -0.12%; p = 0.84).
- Independent Cleveland Clinic review confirmed no evidence of drug-induced cardiotoxicity.
- Phase 1b/2 AML study showed a 50% complete remission (CR) rate and 60% composite complete remission (CRc) rate.
- Median overall survival was 12.39 months in the intent-to-treat population.
- Unblinding from the first 45 patients in the pivotal Phase 2b/3 MIRACLE trial is on track for June 2026.
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