AN2 Therapeutics Provides Regulatory Update and Plan to Initiate Clinical Development for Epetraborole Targeting NTM Lung Disease
– Epetraborole IND Cleared; Received QIDP and Fast Track Designation by FDA
Menlo Park, CA – January 20, 2022 – AN2 Therapeutics, Inc., a clinical-stage biopharmaceutical company focused on developing treatments for rare, chronic, and serious infectious diseases with high unmet needs, announced today that the U.S. Food and Drug Administration (FDA) cleared the Company’s Investigational New Drug (IND) application for epetraborole, a once-daily, orally administered investigational treatment for patients with non-tuberculous mycobacterial (NTM) lung disease in December. In addition, the FDA also granted Qualified Infectious Disease Product (QIDP) and Fast Track Designation for the development of epetraborole in treatment-refractory Mycobacterium avium complex (MAC) lung disease in December.
“The clearance of the IND and receipt of QIDP and Fast Track Designation for epetraborole are significant regulatory milestones for AN2 that allow us to advance our clinical development strategy.” said Eric Easom, President and Chief Executive Officer of AN2 Therapeutics, Inc.
About AN2 Therapeutics, Inc.
AN2 Therapeutics, Inc. is a clinical-stage biopharmaceutical company developing treatments for rare, chronic, and serious infectious diseases with high unmet needs. AN2 is developing epetraborole, a once-daily oral treatment for patients with NTM lung disease, a rare, chronic and progressive infectious disease caused by bacteria known as mycobacteria that lead to irreversible lung damage and can be fatal. For more information, visit www.an2therapeutics.com.
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