AN2 Therapeutics, Inc. provided an update on the ex-U.S. development plan for epetraborole in treatment-refractory Mycobacterium avium complex (MAC) lung disease, the most common form of non-tuberculous mycobacterial (NTM) lung disease. Results from Phase 1 PK/Safety Study of Oral Epetraborole in Japan (EBO-103): This Phase 1 study was designed to evaluate the pharmacokinetics, safety, and tolerability of oral epetraborole administered as a single 500 mg dose to healthy Japanese volunteers with different alcohol dehydrogenase (ADH) genotypes. Results of the study showed that no subjects experienced treatment-emergent adverse events and support use of AN2's recommended dose in Japanese patients enrolled in its ongoing Phase 2/3 study.

Epetraborole exposures were similar amongst patients with different ADH genotypes, and consistent with those observed in non-Japanese subjects in a previously reported Phase 1 study (EBO-101). European UnionOrphan Medicinal Product Designation: In August, the Company received the orphan medicinal product designation for epetraborole in NTM lung disease from the European Commission, which grants orphan medicinal product designation to medicines intended for the treatment, prevention or diagnosis of a life-threatening or very serious condition, with a prevalence in the European Union of not more than five in 10,000 people, and where either no satisfactory method of diagnosis, prevention or treatment of the condition in question exists, or if such method exists that the medicinal product will be of significant benefit to those affected by that condition. The designation provides various incentives, including ten-year market exclusivity upon regulatory approval, if received, fee reductions, and access to protocol assistance.