Acadia Pharmaceuticals announced that it will develop ACP-101 (formerly LV-101) intranasal carbetocin for the treatment of excessive hunger in Prader-Willi syndrome (PWS). Acadia acquired the rights to the nasal spray when it acquired Levo Therapeutics in June 2022. Levo had licensed the intranasal carbetocin from Ferring Pharmaceuticals in 2017 and initiated Phase 3 development in 2018.
Levo initiated a Phase 3 trial of LV-101 in December 2018. The study stopped enrolling PWS patients early due to the COVID-19 pandemic, and in August 2020, Levo announced that the trial had missed its primary endpoint but demonstrated improvement in some secondary endpoints. The FDA accepted Levo’s NDA for priority review in July 2021.
In January 2022, the FDA issued a complete response letter to the NDA, with the agency requesting additional efficacy data for the 3.2 mg dose. Acadia Executive VP Doug Williamson said, “We recently met with the FDA and reached alignment to further evaluate the 3.2 milligram dose of ACP-101 in a pivotal Phase 3 study. If positive, we plan to promptly submit a new drug application for the treatment of hyperphagia in PWS to the FDA.”
Acadia President and CEO Steve Davis commented, “Acadia’s acquisition of ACP-101 demonstrates our commitment to acquiring and developing novel drug candidates that address significant unmet needs in central nervous system disorders. The addition of this drug candidate to our rare disease portfolio is an important next step in the execution of our business development strategy. Prader-Willi syndrome is a rare genetic disorder with no approved treatments, characterized by life-threatening hyperphagia, in addition to a broad range of severe metabolic issues and behavioral challenges. We look forward to working with the Prader-Willi community and clinical experts as we continue to advance development of this program.”
Read the Acadia Pharmaceuticals press release.
