AN2 Therapeutics Announces Voluntary Pause in Enrollment for Epetraborole Clinical Trial
AN2 Therapeutics, a biopharmaceutical company focused on developing innovative treatments for serious infectious diseases, has announced a voluntary pause in the enrollment of its Phase 2/3 clinical trial for epetraborole, a potential treatment for MAC lung disease. The decision to pause enrollment was based on a blinded aggregate analysis of the ongoing Phase 2 study, which indicated potentially lower efficacy than anticipated. Safety concerns were not a factor in this decision.
The double-blind trial consists of two arms, with one comparing epetraborole plus optimized background regimen (OBR) and the other comparing placebo plus OBR. By pausing enrollment, AN2 Therapeutics aims to carefully review the study data and seek input from the independent Data Safety Monitoring Board for their unblinded assessment and recommendations. Possible next steps could involve making changes to the Phase 3 part of the study protocol.
The Phase 2 part of the trial, which enrolled 80 patients and was completed in September 2023, is still expected to announce topline data in the summer of 2024. AN2 Therapeutics has assured that patients already enrolled in the Phase 2 trial will be allowed to continue their participation.
MAC lung disease, or Mycobacterium avium complex lung disease, is a serious respiratory condition caused by a group of bacteria found in soil and water. It is known to affect individuals with weakened immune systems, such as those with HIV or chronic lung diseases, and can cause symptoms such as persistent cough, fatigue, and shortness of breath.
AN2 Therapeutics’ decision to pause enrollment in the Phase 2/3 clinical trial demonstrates the company’s commitment to ensuring the efficacy and safety of epetraborole, which has the potential to make a significant impact on the lives of patients suffering from MAC lung disease.
Analyst comment
Neutral news. AN2 Therapeutics has announced a voluntary pause in enrollment for its Phase 2/3 clinical trial for epetraborole due to potentially lower efficacy. Safety concerns were not a factor. The company plans to review data and seek recommendations for possible changes to the Phase 3 protocol. The Phase 2 trial’s topline data is still expected in summer 2024. The pause shows the company’s dedication to ensuring efficacy and safety for MAC lung disease patients.
