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 ( ANTX ) 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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