AN2 Therapeutics, a biopharmaceutical company, has made the decision to voluntarily pause Phase 3 enrollment in its Phase 2/3 clinical trial for the treatment-refractory MAC lung disease. This pause is pending further data review.
Trial Details
The double-blind trial consists of two arms. One arm compares epetraborole plus optimized background regimen (OBR), while the other arm compares placebo plus OBR.
The reasoning behind the voluntary pause is an aggregate analysis of the ongoing Phase 2 study. This analysis, which includes pooled patients from both treatment arms, revealed potentially lower than expected efficacy. Safety concerns were not a factor in this decision.
Next Steps
AN2 Therapeutics plans to announce topline data from the Phase 2 part of the trial in summer of 2024 as previously anticipated. In the meantime, the enrollment pause will provide an opportunity for a more thorough evaluation of the study data.
Additionally, an independent Data Safety Monitoring Board will conduct an unblinded assessment and make recommendations for the next steps. This could potentially involve changes to the Phase 3 part of the study protocol.
Enrollment Status
The Phase 2 part of the trial successfully completed enrollment in September 2023 with 80 patients. Patients who have already been enrolled in the Phase 2 trial will be allowed to continue their participation in the study.
For any further inquiries, please contact Chris Wack.
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