Galera presents positive Phase 3 ROMAN one-year data; meta-analysis confirms SOM reduction; NDA on track

Galera Therapeutics, Inc.

One-year follow-up: avasopasem maintained comparable tumor outcomes and overall survival vs placebo in HNC patients.
CKD incidence 10% (avasopasem) vs 20% (placebo) at one year (p=0.0043), a 50% reduction.
Meta-analysis (n=551): avasopasem reduced SOM incidence by 19% (p=0.0053) and median days of SOM by 58% (p=0.0002).
Meta-analysis also showed 28% delay in SOM onset (p=0.0005) and 32% reduction in Grade 4 incidence (p=0.0102).
NDA submission for avasopasem for radiotherapy-induced SOM still on track for end of 2022.

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