AN2 Therapeutics Halts Enrollment for Lung Disease Study Due to Lower-Than-Expected Efficacy
AN2 Therapeutics Pauses Study Enrollment
AN2 Therapeutics, a leading biopharmaceutical company, has announced a pause in further enrollment for its mid-to-late-stage study. The study is focused on testing an experimental drug designed to treat a type of bacterial lung infection. The decision to halt enrollment is due to potentially lower-than-expected efficacy as indicated by preliminary data analysis.
Phase 3 Enrollment Paused for Epetraborole Trial
The drug under trial, epetraborole, is under a seamless Phase 2-3 clinical trial. AN2 Therapeutics has voluntarily paused Phase 3 enrollment due to lower than expected efficacy indicated by blinded aggregate analysis. It’s important to note that this pause is not due to safety concerns. Instead, it is a proactive measure taken by the company to ensure the efficacy of the drug being tested.
Company Aims for a Thorough Assessment of Data
The pause in enrollment will allow for a more thorough evaluation of the study data. During this pause, the independent Data Safety Monitoring Board (DSMB) will conduct an unblinded assessment and recommend next steps. These next steps could include changes to the Phase 3 part of the study protocol. The Phase 2 part of the trial, which has already completed enrollment with 80 patients, will greatly inform these recommendations.
Phase 3 Enrollment Status
Before the decision to pause was made, nearly 100 patients had already been enrolled in the Phase 3 part of the trial. These patients will be allowed to continue in the trial, ensuring that their participation and the data gathered from them will not go to waste. This ongoing part of the trial is crucial for gaining a better understanding of the drug’s efficacy and potential application in treating bacterial lung infections.
Implications for the Future
AN2 Therapeutics plans to announce topline data from the Phase 2 part of the trial in summer 2024. The findings from this Phase 2 trial will be used to inform clinical response measures evaluated in the Phase 3 part of the trial and confirm the final sample size. It signifies the company’s commitment to rigorous and thorough research, even in the face of unexpected challenges. It is an approach that prioritizes the safety and health of the patient above all else, ensuring that only the most effective treatments make it to market.