Moleculin Secures Orphan Drug Designation for Annamycin to Treat AML

The FDA has granted an orphan drug designation to Moleculin’s Annamycin for the treatment of acute myeloid leukemia.

Annamycin is an anthracycline designed produce little to no heart muscle damage and avoid drug resistance mechanisms that are often common in similar chemotherapies.

Moleculin has evaluated Annamycin in 114 patients in 6 clinical trials — half of which focused on leukemia with little to no cardiotoxicity, while the other half centered on leukemia.

The company said it is working with the FDA on an IND for Annamycin as a second-line treatment of relapsed or refractory AML.