ANTX News & Events

AN2 Therapeutics announced the initiation of a Phase 2 investigator-initiated clinical trial evaluating the safety, efficacy, and pharmacokinetics of epetraborole, an orally administered inhibitor of leucyl-tRNA synthetase, for the treatment of pulmonary disease caused by Mycobacterium abscessus. The 84-patient, multicenter, randomized, double-blind study is being led by Dr. Kevin Winthrop at Oregon Health & Science University, in collaboration with other investigators across an estimated 10-15 sites in the U.S. Patient screening has been initiated, with topline data planned for late 2027. "Individuals living with M. abscessus lung disease face an incredibly difficult treatment journey, and today's milestone reflects our commitment to changing that trajectory," said Eric Easom, Co-founder, Chairman, President, and CEO of AN2 Therapeutics. "M. abscessus pulmonary infection is a serious condition with no FDA-approved therapies and limited treatment options. We believe epetraborole's oral dosing and targeted novel mechanism provide a strong foundation as we work to deliver better, more accessible treatment solutions for patients who urgently need them."

"Our recent decision to advance oral epetraborole into a Phase 2 study for polycythemia vera highlights the growing opportunity across AN2's boron chemistry pipeline and our commitment to addressing serious, underserved diseases. It also represents one of three proof-of-concept catalysts we believe we are well positioned to achieve in the next two years, including the Phase 2 investigator-initiated trial in M. abscessus complex lung disease and a Phase 2 proof-of-concept study in chronic Chagas disease planned for later this year, pending the outcome of our Phase 1 study," said Eric Easom, Co-Founder, Chairman, President, and CEO of AN2 Therapeutics. "Looking ahead, we remain on track to bring two boron-based oncology candidates into development in 2026, further demonstrating the versatility of our platform. I'm proud of the momentum we're carrying into the year and the continued execution from our team as we work to deliver impactful therapies to patients with urgent unmet needs."

AN2 Therapeutics "announced its plans to expand the development of oral epetraborole into a Phase 2 proof-of-concept clinical study in adults with phlebotomy-dependent polycythemia vera. PV is a blood cancer characterized by overproduction of red blood cells in the bone marrow. This overproduction increases hematocrit which can lead to serious medical complications, including arterial and venous thromboembolic events. The company's decision to pursue PV is supported by data from multiple clinical trials of oral epetraborole in healthy volunteers and non-PV patients in which the drug consistently demonstrated early, controlled, sustained, and dose-dependent reductions in hematocrit at potentially clinically meaningful levels for PV. The Company is currently proceeding through the regulatory clearance process and anticipates initiating the Phase 2 trial in the third quarter of 2026. The Company expects to provide periodic public data updates as early as the fourth quarter of 2026, subject to regulatory clearance and enrollment progress."

AN2 Therapeutics announced that the FDA has cleared Oregon Health & Science University's, or OHSU, investigational new drug, or IND, application to proceed with an IIT that will evaluate the safety, efficacy, and pharmacokinetics of epetraborole in patients with Mycobacterium abscessus lung disease.