AN2 Therapeutics, Inc. announced that it has commenced the Phase 3 part of its Phase 2/3 clinical trial evaluating once-daily, oral epetraborole for treatment-refractory MAC lung disease after completing Phase 2 enrollment. The Phase 2/3 clinical trial is expected to support regulatory filings for approval in the U.S. and Japan. AN2 anticipates reporting Phase 2 topline data in summer 2024.

The FDA has granted epetraborole Fast Track designation for treatment-refractory MAC lung disease, Qualified Infectious Disease Product designation for treatment-refractory MAC lung disease, and orphan drug designation for the treatment of infections caused by nontuberculous mycobacteria (NTM).