Acadia Pharmaceuticals has announced that the Phase 3 COMPASS PWS trial of ACP-101 carbetocin nasal spray in Prader-Willi syndrome patients with hyperphagia failed to meet any of its endpoints, including the primary endpoint of change from baseline to Week 12 on the Hyperphagia Questionnaire for Clinical Trials. The company announced the initiation of the study in November 2023.
Acadia announced plans to develop ACP-101 for hyperphagia in PWS in June 2023 after having acquired the carbetocin nasal spray (formerly LV-101) when it acquired Levo Therapeutics the previous year. A previous Phase 3 trial conducted by Levo missed its primary endpoint but demonstrated improvement in some secondary endpoints. Levo had submitted an NDA for LV-101 in 2021, and the agency issued a CRL to that application in January 2022.
Acadia Head of Research and Development Elizabeth H.Z. Thompson commented, “We are disappointed by these findings, especially for Prader-Willi syndrome patients, their families and the entire community. I want to thank the many patients, families, study site personnel, and physicians who participated in the COMPASS PWS study as well as the intranasal carbetocin clinical development program, for their dedication and contributions in this important study. We are committed to sharing a summary of the data in the future to ensure learning for the PWS community; however, given these results, we do not intend to investigate intranasal carbetocin any further.”
Read the Acadia Pharmaceuticals press release
