AN2 Therapeutics, a biopharmaceutical company, has announced its decision to voluntarily pause Phase 3 enrollment in its Phase 2/3 clinical trial for the evaluation of epetraborole in treatment-refractory MAC lung disease. This decision comes after a blinded aggregate analysis of the ongoing Phase 2 study revealed potentially lower than expected efficacy. However, it is important to note that the pause was not due to safety concerns.
Trial Details and Progress
The double-blind trial consists of two arms, comparing epetraborole plus optimized background regimen (OBR) against placebo plus OBR. The voluntary pause in enrollment will provide AN2 Therapeutics with the opportunity to thoroughly evaluate the study data and allow the independent Data Safety Monitoring Board to conduct an unblinded assessment. Based on their findings, recommendations for the Phase 3 part of the study protocol may be made, which could include necessary changes.
Impact on Stock Performance
AN2 Therapeutics’ shares experienced a significant drop of 73% to $5.41 following this announcement. This decline compounds the company’s overall performance over the past year, with a decrease of 63% from its 52-week high of $22.22 on Jan. 10.
Future Expectations and Timelines
Despite this setback, the company remains committed to advancing its research and development efforts. AN2 Therapeutics anticipates sharing topline data from the Phase 2 portion of the trial during the summer of 2024. As the Phase 2 trial concluded enrollment in September with 80 patients, those already enrolled will continue their participation in the study.