AN2 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

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.

The company’s decision to pause enrollment enables time to further evaluate study data and for the independent Data Safety Monitoring Board (DSMB) to conduct an unblinded assessment and recommend next steps, which could include changes to the Phase 3 part of the study protocol. The Phase 2 part of the trial completed enrollment in September 2023 with 80 patients. The Phase 3 part of the trial has enrolled nearly 100 patients to date, a faster enrollment rate than previously anticipated. Patients already enrolled in the Phase 2/3 trial will be allowed to continue on study.

“Developing new therapies for patients suffering with treatment-refractory MAC lung disease, a disease with limited treatment options and low response rates to existing therapies, is a complex undertaking. In light of recently available blinded aggregate data, we believe our voluntary decision to pause enrollment in the Phase 3 part of the study will provide us the opportunity to further evaluate study data, and determine the best path forward,” said Eric Easom, Co-Founder, President and Chief Executive Officer of AN2 Therapeutics. “We plan to provide further details regarding the epetraborole Phase 2/3 clinical trial in the second quarter of 2024 following completion of our analysis.”