Phase III ROMAN results for GC 4419 in Head and Neck cancer presented at European Congress on Head and Neck Oncology.- Galera Therapeutics

The analysis further demonstrates the overall impact of avasopasem manganese (avasopasem) in reducing the burden of severe oral mucositis (SOM). Galera’s New Drug Application (NDA) in the U.S. for avasopasem is currently under FDA priority review for radiotherapy (RT)-induced SOM in patients with head and neck cancer undergoing standard-of-care treatment.

Results from two randomized, double-blind, placebo-controlled trials (Phase III ROMAN and Phase IIb GT-201) are the basis of the avasopasem NDA. The Company believes that the supplemental net treatment benefit analysis being presented at ECHNO further supports the avasopasem clinical benefit observed in those trials. It quantitatively demonstrates that the overall improvement in SOM is greater than that captured by any individual endpoint and that the improvement in each of the key SOM endpoints contributes to the benefit.

The FDA accepted the filing and granted priority review to the NDA in February 2023, with a PDUFA target date of August 9, 2023. The FDA previously granted Breakthrough Therapy and Fast Track designations to avasopasem for the reduction of RT-induced SOM. Head and neck cancers are a global problem, as is SOM caused by the standard-of-care RT. The Company intends for avasopasem to help patients beyond the U.S. and plans to meet with the European Medicines Agency (EMA) in 2023 to discuss the potential European registration pathway for avasopasem.