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Acadia Pharmaceuticals Announces Phase 3 COMPASS PWS Trial of Intranasal Carbetocin (ACP-101) for Hyperphagia in Prader-Willi Syndrome Did Not Meet Primary Endpoint
SAN DIEGO--(BUSINESS WIRE)-- Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced top-line results from the Phase 3 COMPASS PWS trial evaluating the
About this update from Acadia Pharmaceuticals Inc.
[{"type":"text","content":" SAN DIEGO--(BUSINESS WIRE)--\nAcadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced top-line results from the Phase 3 COMPASS PWS trial evaluating the efficacy and safety of intranasal carbetocin (ACP-101) in patients with hyperphagia in Prader-Willi syndrome (PWS). Intranasal carbetocin did not demonstrate a statistically significant improvement over placebo on the study’s primary endpoint, change from baseline to Week 12 on the Hyperphagia Questionnaire for Clinical Trials (HQ-CT), nor was there separation from placebo on any secondary endpoint. The safety and tolerability profile of intranasal carbetocin was consistent with previous clinical trials, showing a low rate of adverse events.\n\n\n“We are disappointed by these findings, especially for Prader-Willi syndrome patients, their families and the entire community,” said Elizabeth H.Z. Thompson, Ph.D., Acadia’s Head of Research and Development. “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.”\n\n\nCOMPASS PWS was a 12-week, double-blind, randomized, placebo-controlled global Phase 3 trial evaluating the efficacy and safety of intranasal carbetocin 3.2 mg three times daily (TID) in 175 enrolled children and adults aged five to 30 years with PWS.\n\n\n“Despite this disappointment, Acadia is well-positioned to deliver long-term, sustainable growth supported by two approved products projected to generate over $1 billion in net sales in 2025, and a robust pipeline that includes eight disclosed and multiple undisclosed programs,” said Catherine Owen Adams, Acadia’s Chief Executive Officer. “Looking ahead, we anticipate seven Phase 2 or 3 study starts through 2026 and four data readouts by the end of 2027. For more details on our programs, I encourage you to revisit our recent R&D Day presentation on our website.”\n\n\nAbout Acadia Pharmaceuticals\n\n\nAcadia is advancing breakthroughs in neurological and rare diseases to elevate life. Since our founding we have been work...