Galera Therapeutics
Galera developed avasopasem, a synthetic enzyme mimic meant to prevent the severe mouth ulcers of head and neck radiotherapy; the FDA declined approval in 2023 despite a positive phase 3 trial.
Overview
Galera Therapeutics, based in Malvern, Pennsylvania, developed avasopasem manganese, a superoxide dismutase mimetic, to reduce severe oral mucositis in patients having chemoradiotherapy for head and neck cancer. The phase 3 ROMAN trial met its primary endpoint but the FDA issued a complete response letter in 2023 asking for a further trial. Its trials remain on ClinicalTrials.gov under Galera as lead sponsor.
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