MENLO PARK, Calif. – AN2 Therapeutics, Inc. (NASDAQ:ANTX), a biopharmaceutical company, has announced a voluntary pause in enrolling participants for the Phase 3 segment of its clinical trial, EBO-301, which is testing epetraborole in patients with treatment-refractory Mycobacterium avium complex (MAC) lung disease. This pause is to allow for a thorough review of data following a blinded aggregate analysis that indicated potentially lower efficacy than expected. The company clarified that the decision was not related to safety concerns.
The EBO-301 trial is a double-blind, placebo-controlled study designed to assess the safety and efficacy of epetraborole in combination with an optimized background regimen (OBR) compared to a placebo plus OBR. Although the Phase 3 enrollment has been paused, patients already participating will continue with the study. The Phase 2 portion, which completed enrollment in September 2023 with 80 patients, will inform the next phase of the trial.
The independent Data Safety Monitoring Board (DSMB) will conduct an unblinded assessment and advise on potential modifications to the Phase 3 protocol based on their findings. The Phase 3 segment had seen nearly 100 patients enrolled, surpassing initial enrollment rates.
Eric Easom, Co-Founder, President, and CEO of AN2 Therapeutics, stated that developing treatments for MAC lung disease, which currently has limited effective treatments, is complex. He emphasized the importance of the pause to reevaluate the study data and determine the most appropriate steps forward. The company expects to release top-line data from the Phase 2 segment in the summer of 2024 and plans to provide further details on the clinical trial in the second quarter of 2024.
The primary goal of the Phase 3 trial is to establish the superiority of epetraborole plus OBR over placebo plus OBR in patients with MAC lung disease, a rare and progressive infectious disease that can lead to irreversible lung damage and be fatal.
This announcement is based on a press release statement from AN2 Therapeutics, Inc.
In light of AN2 Therapeutics, Inc.’s recent announcement regarding the pause in their Phase 3 clinical trial, investors and stakeholders may be closely monitoring the company’s financial health and market performance. According to InvestingPro data, AN2 Therapeutics currently holds a market capitalization of $594.83 million. Despite the clinical trial’s challenges, the…