MENLO PARK, Calif.--(BUSINESS WIRE)--AN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical company developing novel small molecule therapeutics derived from its boron chemistry platform, today 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 (LeuRS), for the treatment of pulmonary disease caused by Mycobacterium abscessus (M. abscessus). The 84-patient, multicenter, randomized, double-blind study is being led by Dr. Kevin Winthrop at Oregon Health & Science University (OHSU), 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.
“Mycobacterium abscessus remains one of the most challenging pulmonary pathogens, with limited treatment options consisting of prolonged, poorly tolerated, complex, multidrug daily IV regimens,” said Kevin L. Winthrop, M.D., MPH, Professor of Infectious Diseases and Public Health, Oregon Health & Science University, and principal investigator leading the investigator-initiated study. “An orally administered, novel investigative agent such as epetraborole, if shown to be safe and effective in humans, has the potential to become a backbone agent in multidrug regimens for the treatment of M. abscessus lung disease. A new therapeutic that could reduce the burden imposed by current treatment options and improves outcomes for patients with this difficult-to-treat infection would be welcomed by patients and care providers alike.”
“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.”
For more information about the investigator-initiated clinical trial, please visit Study Details | NCT07301320 | Epetraborole in Patients With Mycobacterium Abscessus Lung Disease | ClinicalTrials.gov.
About M. abscessus Complex Lung Disease
M. abscessus lung disease is a rapidly growing nontuberculous mycobacterium associated with chronic, progressive lung disease that can lead to significant morbidity and mortality. Current treatment typically involves prolonged, multidrug regimens that may be poorly tolerated and have variable success, underscoring the urgent need for new, targeted therapies.
About Epetraborole
Epetraborole is a novel, orally administered, once daily, small molecule inhibitor of leucyl tRNA synthetase (LeuRS), designed to disrupt bacterial protein synthesis. Epetraborole is being developed to address significant unmet medical needs in various therapeutic areas, including difficult-to-treat mycobacterial infections.
About AN2 Therapeutics
AN2 Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on the discovery and development of novel small-molecule therapeutics derived from our boron chemistry platform. Our development pipeline spans hematologic diseases, infectious diseases, and oncology with three Phase 2 studies expected to be active in 2026, two preclinical candidates, as well as advanced research programs focused on targets in oncology, bone disorders, and infectious diseases. We are committed to delivering high-impact drugs to patients that address critical unmet needs and improve health outcomes.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “would,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “believe,” “estimate,” “predict,” “potential,” or “continue,” or the negative of these terms or other similar expressions. Forward-looking statements expressed or implied in this press release include, but are not limited to, statements regarding: epetraborole’s potential to treat M. abscessus lung disease; the ability for efficacy in preclinical models to predict human efficacy; expectations regarding the Company’s clinical trials, including initiation, enrollment, conduct, sites, and the timing of data and related announcements. These statements are based on AN2’s current estimates, expectations, plans, objectives, and intentions, are not guarantees of future performance, and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, but are not limited to, risks and uncertainties related to: risk inherent in IITs, including reliance on third-party investigators and institutions for study conduct, availability and timing of external funding and operational support, site activation and retention, patient identification and enrollment pace, screen-failure rates, protocol adherence, and limited control over trial execution and data quality; the translation of preclinical data to outcomes in clinical trials; the ability to successfully initiate and complete clinical studies, obtain regulatory approvals, and commercialize any resulting products; the timing and success of clinical trials; the unmet need and market opportunity in M. abscessus; the sufficiency of AN2’s capital resources and need for additional capital to achieve its goals and other risks, including those described under the heading “Risk Factors” in AN2’s Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q and other reports filed with the U.S. Securities and Exchange Commission (SEC). These filings, when made, are available on the investor relations section of AN2’s website at www.an2therapeutics.com and on the SEC’s website at www.sec.gov. Forward-looking statements contained in this press release are made as of this date, and AN2 undertakes no duty to update such information except as required under applicable law.
Contacts
COMPANY CONTACT:
Lucy O. Day
Chief Financial Officer
l.day@an2therapeutics.com
INVESTOR AND MEDIA CONTACT:
Anne Bowdidge
ir@an2therapeutics.com
