Acadia Pharmaceuticals' Phase 3 COMPASS PWS Trial Misses Primary Endpoint

(RTTNews) - Acadia Pharmaceuticals Inc. (ACAD) said Wednesday that its Phase 3 COMPASS PWS study of carbetocin for the treatment of patients with hyperphagia or extreme hunger associated with Prader-Willi syndrome failed to meet its primary endpoint.

COMPASS PWS was a 12-week, randomized, placebo-controlled global Phase 3 trial evaluating the efficacy and safety of intranasal carbetocin in individuals aged 5 to 30 years with Prader-Willi syndrome (PWS), a rare genetic disorder. The trial found that intranasal carbetocin did not show a statistically significant improvement over placebo on the primary endpoint—the change from baseline to Week 12 on the Hyperphagia Questionnaire for Clinical Trials (HQ-CT), a caregiver-reported measure of food-seeking behaviors in individuals with PWS.

The safety and tolerability profile of intranasal carbetocin was consistent with previous trials, with a low rate of adverse events.