AN2 Therapeutics, Inc. 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.
<span class="legendSpanClass">Epetraborole IND Cleared; Received QIDP and Fast Track Designation by FDA</span> |
[20-January-2022] |
MENLO PARK, Calif., Jan. 20, 2022 /PRNewswire/ -- 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.
SOURCE AN2 Therapeutics, Inc. |