Acadia Pharmaceuticals said that it has initiated the Phase 3 COMPASS PWS study of ACP-101 carbetocin nasal spray for the treatment of excessive hunger in people with Prader-Willi syndrome (PWS). Acadia acquired the carbetocin nasal spray (formerly LV-101) when it acquired Levo Therapeutics in June 2022 and announced plans to develop ACP-101 for hyperphagia in PWS earlier this year.
A previous Phase 3 trial of the carbetocin nasal spray initiated by Levo in December 2018 was stopped early due to the COVID-19 pandemic. That trial missed its primary endpoint but demonstrated improvement in some secondary endpoints, Levo announced in August 2020.
Levo submitted an NDA for the nasal spray, and the FDA accepted the NDA for priority review in July 2021; however, the agency issued a complete response letter to the NDA in January 2022, citing a need for additional efficacy data for the 3.2 mg dose. According to Acadia, the COMPASS PWS study is expected to enroll approximately 170 people with PWS and will evaluate 3 times daily dosing of the 3.2 mg dose over 12 weeks.
Acadia Senior VP, Global Head of Medical Affairs, and Chief Medical Officer Ponni Subbiah commented, “The launch of the Phase 3 COMPASS PWS trial will build on previous Phase 3 clinical trial experience, where carbetocin nasal spray 3.2 mg was observed to reduce hyperphagia-related behaviors. We look forward to working with the Prader-Willi community and clinical research sites as we continue to advance the ACP-101 clinical development program for those living with this debilitating syndrome and their families.”
Read the Acadia Pharmaceuticals press release.
