AN2 Therapeutics to Voluntarily Pause Enrollment in Phase 3 Part of Phase 2/3 Pivotal Clinical Trial Evaluating Epetraborole for Treatment-Refractory Mycobacterium Avium Complex (MAC) Lung Disease

Author: Benzinga Newsdesk | February 12, 2024 07:46am

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 the company's decision to voluntarily pause Phase 3 enrollment in the seamless Phase 2/3 clinical trial (EBO-301) evaluating epetraborole in treatment-refractory MAC lung disease, pending further data review. The double-blind, placebo-controlled trial has two arms comparing epetraborole plus optimized background regimen (OBR) versus placebo plus OBR. The voluntary pause was instituted following a blinded aggregate analysis of the ongoing Phase 2 study, including pooled patients from both treatment arms, which showed potentially lower than expected efficacy. The decision was not due to safety concerns. The Phase 2 part of the trial is intended to inform the Phase 3 part of the trial. The company continues to expect to announce topline data from the Phase 2 part of the trial in summer 2024.

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