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AN2 Therapeutics Provides Update on EBO-301 Phase 2/3 Study Evaluating Epetraborole for Treatment-Refractory Mycobacterium avium Complex (MAC) Lung Disease
EBO-301 study to be discontinued following topline results from Phase 2 part of the study in treatment-refractory patients with MAC lung disease AN2 plans to
About this update from An2 Therapeutics, Inc.
[{"type":"text","content":"\nEBO-301 study to be discontinued following topline results from Phase 2 part of the study in treatment-refractory patients with MAC lung disease\n\n\nAN2 plans to shift focus to internal boron chemistry platform and ongoing pipeline programs\n\n\nCompany restructuring and cost savings associated with discontinuation of the EBO-301 study expected to extend cash runway through 2027\n\n\n MENLO PARK, Calif.--(BUSINESS WIRE)--\nAN2 Therapeutics, Inc. (Nasdaq: ANTX), a biopharmaceutical company focused on discovering and developing novel small molecule therapeutics derived from its boron chemistry platform today announced topline results from the Phase 2 part of the EBO-301 Phase 2/3 study evaluating epetraborole on top of an optimized background regimen (OBR) in treatment-refractory MAC lung disease.\n\n\nThe Phase 2 part of the study met its primary objective of demonstrating the potential validation of a novel patient-reported outcome (PRO) tool and a higher PRO-based clinical response rate in the epetraborole + OBR arm (39.5%) vs. placebo + OBR (25.0%; treatment difference 13.9%, p=0.19). However, sputum culture conversion at Month 6, a key secondary endpoint, was similar between treatment arms (13.2% in epetraborole + OBR vs. 10.0% placebo + OBR; treatment difference 3.4%, p=0.64).\n\n\nIn February, the Company voluntarily paused new patient enrollment in the Phase 3 part of the study due to potentially lower-than-expected efficacy observed in blinded aggregate data. Based on the topline data announced today, the Company will terminate the Phase 2 (80 patients) and Phase 3 parts of the EBO-301 trial (97 patients enrolled prior to pause). Oral epetraborole 500 mg daily was generally well-tolerated and the study was not terminated due to safety concerns.\n\n\n“These results are deeply disappointing as there is a high unmet need for new therapies in treatment-refractory MAC lung disease,” said Eric Easom, Co-founder, Chairman, President and CEO. “We sincerely thank the patients, investigators, study site staff and AN2 employees who were part of the journey to investigate the prospects of epetraborole in this very difficult-to-treat patient population.”\n\n\n“In the coming months, we will further evaluate the results from the EBO-301 study and make informed decisions regarding potential future development of epetraborole for NTM l...