Galera submits NDA for avasopasem to reduce severe oral mucositis in head & neck cancer

Galera Therapeutics, Inc.

NDA for avasopasem submitted to FDA for radiotherapy-induced severe oral mucositis (SOM) in head/neck cancer.
Two positive placebo-controlled trials (Phase 3 ROMAN, Phase 2b GT-201) enrolled 678 patients total.
ROMAN trial: statistically significant reduction in SOM incidence; median SOM days more than halved vs placebo.
Prospectively defined analysis showed avasopasem reduced cisplatin-related chronic kidney disease by 50%.
FDA previously granted Fast Track and Breakthrough Therapy designations; no approved SOM drug currently exists.

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