Posted by Michael Wonder on 01 Mar 2018
Galera Therapeutics receives FDA breakthrough therapy designation for GC4419 for the reduction of severe oral mucositis
28 February 2018 - Designation based on positive results of Phase 2b trial of GC4419.
Galera Therapeutics today announced that the U.S. FDA has granted breakthrough therapy designation to lead candidate GC4419, a highly selective and potent small molecule dismutase mimetic, for the reduction of the duration, incidence and severity of severe oral mucositis (SOM) induced by radiation therapy with or without systemic therapy.
GC4419 has also received fast track designation from the FDA for the reduction of the severity and incidence of radiation and chemotherapy-induced OM.
