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AN2 Therapeutics Initiates Pivotal Phase 2/3 Trial Evaluating Epetraborole for Treatment-Refractory MAC Lung Disease
AN2 is developing epetraborole as a once-daily, orally administered treatment with a novel mechanism of action for patients with NTM lung disease, with an
About this update from An2 Therapeutics, Inc.
[{"type":"text","content":"AN2 is developing epetraborole as a once-daily, orally administered treatment with a novel mechanism of action for patients with NTM lung disease, with an initial focus on treatment-refractory MAC lung diseasePhase 2/3 pivotal trial expected to support regulatory approval for treatment-refractory MAC lung disease; Plan to use LPAD pathway MENLO PARK, Calif., June 29, 2022 (GLOBE NEWSWIRE) -- AN2 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 announced it has screened its first patient in its pivotal Phase 2/3 clinical trial evaluating once-daily, oral epetraborole for treatment-refractory Mycobacterium avium complex (MAC) lung disease, the most common form of nontuberculous mycobacterial (NTM) lung disease. “Initiating this pivotal Phase 2/3 trial marks an important step towards delivering a new treatment option to patients with treatment-refractory MAC lung disease, an area which has seen little innovation,” said Eric Easom, President and Chief Executive Officer of AN2 Therapeutics. “As a once-daily oral therapy, epetraborole has the potential to become an important component of a multi-drug treatment regimen for patients with treatment-refractory MAC lung disease. We look forward to sharing clinical data from the Phase 2 portion of this trial in mid-2023, when we expect to get our first clinical readout on the impact of epetraborole added to a standard of care regimen.” AN2 Therapeutics believes that compelling data from this pivotal Phase 2/3 clinical trial could allow the company to seek approval for epetraborole with the U.S. Food and Drug Administration (FDA) using the Limited Population Pathway for Antibacterial and Antifungal drugs (LPAD) and in other geographies. Under the LPAD pathway, the FDA may approve and review new antibacterial drugs to treat serious bacterial diseases in patients with an unmet medical need and for which effective bacterial drugs are limited or lacking, potentially resulting in a New Drug Application submission based on streamlined development. Epetraborole has been granted Qualified Infectious Disease Product and Fast Track status by the FDA for treatment-refractory MAC lung disease, as well as orphan drug designation for the treatment of infections caus...