Lung Disease Focused AN2 Therapeutics' Lackluster Data Prompts To Stop Phase 3 Study Of Lung Infection Candidate, Halves Workforce

On Thursday, AN2 Therapeutics, Inc. ANTX released topline results from the Phase 2 part of the EBO-301 Phase 2/3 study of epetraborole on top of an optimized background regimen (OBR) in treatment-refractory mycobacterium avium complex (MAC) lung disease.

The 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).

In 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 today’s topline data, the company will terminate the Phase 2 (80 patients) and Phase 3 parts of the EBO-301 trial (97 patients enrolled before pause).

Oral epetraborole 500 mg daily was generally well-tolerated and the study was not terminated due to safety concerns.

“In the coming months, we will further evaluate the results from the EBO-301 study and make informed decisions regarding the potential future development of epetraborole for NTM lung disease in other patient populations,” said Eric Easom, Co-founder, Chairman, President, and CEO.

“We plan to embark on a strategic restructuring and expect to extend our cash runway through 2027, focusing our cash resources on advancing our pipeline through multiple milestones,” said Easom.

In an SEC filing, AN2 Therapeutics announced that it will reduce its workforce by 50% following the discontinuation of the EBO-301 study.

The company expects to incur approximately $2-$3 million charges.

Price Action: ANTX stock is down 60.2% at $1.05 at last check Friday.

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