Business
AN2 Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Recent Highlights
Approaching 60 clinical sites participating in pivotal Phase 2/3 trial of epetraborole in treatment-refractory Mycobacterium avium complex (MAC) lung disease
About this update from An2 Therapeutics, Inc.
[{"type":"text","content":"\n\nApproaching 60 clinical sites participating in pivotal Phase 2/3 trial of epetraborole in treatment-refractory Mycobacterium avium complex (MAC) lung disease to date\n\n\nOpened up sites in three additional countries -- Japan, South Korea, and Australia in addition to the U.S.; Japan has some of the highest rates of MAC lung disease in the world\n\n\nActivities underway to advance development of epetraborole for acute systemic melioidosis using non-dilutive funding\n\n\n MENLO PARK, Calif.--(BUSINESS WIRE)--\nAN2 Therapeutics, Inc. (Nasdaq: ANTX), a clinical-stage biopharmaceutical company focused on developing treatments for rare, chronic, and serious infectious diseases with high unmet needs, today reported financial results for the fourth quarter and year ended December 31, 2022.\n\n“2022 was a transformative year for AN2 as we transitioned from a private company into a public company and initiated a single pivotal Phase 2/3 clinical trial, EBO-301, for epetraborole in treatment-refractory MAC lung disease. We continued to generate data that support the potential of epetraborole to meet an ideal target product profile for NTM lung disease caused by MAC. Importantly, based on discussions with FDA and the Japanese Pharmaceuticals and Medical Devices Agency (PMDA), we believe that our pivotal trial, if positive, will be sufficient to support regulatory filings in these two major markets. We also gained alignment with the PMDA on the use of a microbiological primary endpoint to support potential registration and received orphan medicinal product designation from the European Union,” said Eric Easom, Co-Founder, President and Chief Executive Officer. “Enrollment is ongoing in the Phase 2/3 pivotal trial of epetraborole. We are approaching 60 clinical sites worldwide, including new sites in Japan, South Korea and Australia. Japan has some of the highest rates of MAC lung disease in the world, making it and the broader Asia-Pacific region an area of particular importance as we look to make a significant impact on the lives of patients worldwide.”\n\nHighlighting the company’s commitment to global health using non-dilutive funding, AN2 was awarded a contract in the third quarter of 2022 valued up to $17.8M from the National Institute of Allergy and Infectious Disease to develop epetraborole for acute systemic melioidosis and othe...