Clinical TrialMay 29, 2026, 09:36 AM
Moleculin Biotech Annamycin Shows No Cardiotoxicity at ASCO 2026
AI Summary
Moleculin Biotech, Inc. announced new data at the 2026 ASCO Annual Meeting, demonstrating that its lead drug candidate, Annamycin, exhibited no detectable cardiotoxicity. This was observed across five clinical trials, even at cumulative exposure levels significantly exceeding conventional anthracycline limits. The findings, independently reviewed by Cleveland Clinic, reinforce Annamycin's differentiated cardiac safety profile. The company also highlighted previously reported efficacy data from its Phase 1b/2 AML study, including a 50% complete remission rate, and confirmed that unblinding for the pivotal Phase 2b/3 MIRACLE trial is on track for June 2026.
Key Highlights
- Annamycin showed no detectable cardiotoxicity in a pooled analysis across five clinical trials.
- Patients received a median cumulative Annamycin dose of 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 review by Cleveland Clinic cardiology specialists confirmed no evidence of drug-induced cardiotoxicity.
- Previously reported Phase 1b/2 AML study showed a 50% complete remission (CR) rate.
- The Phase 1b/2 AML study also demonstrated a 60% composite complete remission (CRc) rate.
- Median overall survival was 12.39 months in the intent-to-treat population of the AML study.
- Unblinding from the first 45 patients of the pivotal Phase 2b/3 MIRACLE trial is on track for June 2026.
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