By Stephen Nakrosis
AN2 Therapeutics said it was planning to meet with the U.S. Food and Drug Administration to discuss a development path for epetraborole, a treatment of non-tuberculous mycobacterial lung disease.
The company said it will seek an End-of-Phase 2 meeting with the FDA in the first half of next year, and expects to leverage insights from Phase 2 results to evaluate potential reinitiation of a Phase 3 study. AN2 also said it will seek to align with the agency on a statistical analysis plan for 97 patients who completed six months of treatment in a trial which was halted August. The company said it expects to release top-line Phase 3 data from these patients in mid-2025, subject to the timing of discussions with the FDA.
Eric Easom, the company's co-founder, chairman, president and chief executive officer, said recent data analysis indicate that epetraborole may provide clinical improvement in patients with treatment-refractory MAC lung disease.
The company said epetraborole is the first drug candidate with statistically favorable patient reported outcome-based improvement in a treatment-refractory Mycobacterium avium Complex population.
AN2 also said it is continuing to advance its pipeline of boron-based compounds to address unmet patient needs.
Write to Stephen Nakrosis at stephen.nakrosis@wsj.com
(END) Dow Jones Newswires
November 13, 2024 17:06 ET (22:06 GMT)
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