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AN2 Therapeutics Announces FDA Clearance to Proceed with 90-Patient Investigator-Initiated Trial (IIT) of Epetraborole in Patients with M. abscessus Lung Disease
MENLO PARK, Calif., January 12, 2026--AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company advancing novel small molecule therapeutics derived from its boron chemistry platform, today announced that the U.S. Food and Drug Administration has cleared Oregon Health & Science University’s (OHSU) Investigational New Drug (IND) application to proceed with an IIT that will evaluate the safety, efficacy, and pharmacokinetics of epetraborole in patients with Mycobacterium abscessus lung dis
About this update from An2 Therapeutics, Inc.
[{"type":"image","alt":"","displaySize":"","headline":null,"caption":"","credit":null,"className":"","disableSlideshowImg":false,"size":{"original":{"width":480,"height":270,"url":"https://media.zenfs.com/en/business-wire.com/602c99a4566b7b33671b5851ad04268a"},"resized":{"url":"https://s.yimg.com/ny/api/res/1.2/6.vR9veIH7Mx7tArRNkAHQ--/YXBwaWQ9aGlnaGxhbmRlcjt3PTk2MDtoPTU0MDtjZj13ZWJw/https://media.zenfs.com/en/business-wire.com/602c99a4566b7b33671b5851ad04268a","width":480,"height":270}},"lazy":false},{"type":"text","content":"AN2 aims to advance oral treatment option for patients currently reliant on complex, off-label IV therapies","length":107,"tagName":"p","attribs":{}},{"type":"text","content":"Led by nontuberculous mycobacteria (NTM) expert Dr. Kevin Winthrop, trial will focus on early-stage, treatment-naive patients, a key difference from AN2's previous studies in mycobacterium avium complex (MAC)","length":212,"tagName":"p","attribs":{}},{"type":"text","content":"Patient enrollment expected to be initiated in 1Q 2026","length":54,"tagName":"p","attribs":{}},{"type":"text","content":"MENLO PARK, Calif., January 12, 2026--(BUSINESS WIRE)--AN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company advancing novel small molecule therapeutics derived from its boron chemistry platform, today announced that the U.S. Food and Drug Administration has cleared Oregon Health & Science University’s (OHSU) Investigational New Drug (IND) application to proceed with an IIT that will evaluate the safety, efficacy, and pharmacokinetics of epetraborole in patients with Mycobacterium abscessus lung disease (M. abscessus). The multicenter, randomized, double-blind, placebo-controlled, prospective clinical study will be led by Dr. Kevin Winthrop, Professor of Public Health and Infectious Diseases at OHSU, in collaboration with other investigators across an estimated 10-15 sites in the U.S.","length":812,"tagName":"p"},{"type":"text","content":""Current treatment for M. abscessus relies on off-label, complex intravenous drug regimens that are difficult to tolerate, provide modest efficacy and are burdensome to patients," said Dr. Winthrop. "Patients need oral therapies that are efficacious and well tolerated, and epetraborole has the potential to address this unmet need in M. abscessus patients. Currently there are no FDA-approved therapeu...