Moleculin Biotech’s Phase 3 trial of Annamycin approved by Review Board

Moleculin Biotech (MBRX) has received Institutional Review Board – IRB – approval for its Phase 3 pivotal trial protocol evaluating Annamycin in combination with Cytarabine for the treatment of AML patients who are refractory to or relapsed after induction therapy. This Phase 3 “MIRACLE” trial will be a global trial, including sites in the US. The company believes enrollment will commence in Q1 2025. Annamycin currently has Fast Track Status and Orphan Drug Designation from the FDA for the treatment of relapsed or refractory acute myeloid leukemia, in addition to Orphan Drug Designation for the treatment of soft tissue sarcoma. Furthermore, Annamycin has Orphan Drug Designation for the treatment of relapsed or refractory acute myeloid leukemia from the European Medicines Agency.