other material
confidence high
sentiment neutral
materiality 0.60
AN2 screens first patient in pivotal Phase 2/3 trial of epetraborole for refractory MAC lung disease
AN2 Therapeutics, Inc.
- Epetraborole is a once-daily oral therapy with novel MOA for treatment-refractory MAC lung disease, the most common NTM lung disease.
- Phase 2/3 adaptive trial (EBO-301) targets ~314 patients; Phase 2 topline expected mid-2023, Phase 3 mid-2024.
- Epetraborole has FDA QIDP, Fast Track, and Orphan Drug designations; plans to use LPAD pathway for streamlined approval.
- First patient screened; Phase 2 will assess clinical response, safety, and PK to inform Phase 3 design.