Moleculin Biotech, Inc. reported promising results from its Phase 1B/2 clinical trial of Annamycin for treating soft tissue sarcoma lung metastases, revealing a clinical benefit rate of 59.4% after two treatment cycles. The study involved 36 patients and demonstrated improved overall survival (OS) and progression-free survival (PFS), particularly in those with fewer prior chemotherapy treatments. The median OS was 411 days and median PFS was 63 days for all participants, with enhanced outcomes for those receiving optimized doses (OS of 19.9 months and PFS of 127 days).
The potential market for Annamycin is significant, projected to reach $2.6 billion by 2030, addressing approximately 13,500 new cases of soft tissue sarcoma annually. Annamycin currently holds Fast Track Status and Orphan Drug Designation from the FDA for both soft tissue sarcoma and acute myeloid leukemia. The webcast discussing these findings will be available on June 5, 2025.