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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.
Also called: Galera Therapeutics, Inc.Galera
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.
Headquarters
Malvern, PA, US
Scorecard
All companies#372of 1244 companies, score 10
- phase 3 +3
- modalities +2
- registry trials +5
0 approved, 1 in phase 3, 0 earlier, 0 targets, 6 registry studies. Formula on the scorecards page.
Type
Stage
Public
Website
Phase 3Superoxide dismutase mimetic small molecule
Avasopasem is Galera Therapeutics' radioprotector for the severe mouth ulcers of head and neck chemoradiation; its phase 3 trial met its main goal but the FDA asked for another study in 2023.
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Phase 3Superoxide dismutase mimetic small molecule