Alkermes reports additional phase 2 alixorexton data in narcolepsy type 1
Additional phase 2 data showed alixorexton sustained improvements in disease severity, cognition and fatigue in narcolepsy type 1 through weeks 12-13. The oral orexin 2 receptor agonist was generally well tolerated, with no serious treatment-emergent adverse events reported.
Alixorexton demonstrated sustained improvements in patient-reported disease severity, cognitive functioning and fatigue in the seven-week open-label extension of the Vibrance-1 phase 2 study in patients with narcolepsy type 1. The drug was generally well tolerated at all doses tested, and the phase 3 Brilliance NT1 study is ongoing.
Vibrance-1, a randomized, placebo-controlled, double-blind phase 2 study conducted in 92 patients with NT1, demonstrated clinically meaningful and statistically significant improvements from baseline compared to placebo in wakefulness, cognition, and fatigue. New data from the seven-week open-label extension demonstrated that improvements observed at week 6 across patient-reported measures of disease severity, cognitive functioning and fatigue were sustained through weeks 12-13.
Exploratory patient-reported outcomes in Vibrance-1 included the Narcolepsy Severity Scale-Clinical Trials, British Columbia Cognitive Complaints Inventory, Patient Global Impression of Severity for Cognition, PROMIS-Fatigue Short-form 6a, and Patient Global Impression of Severity for Fatigue. Clinically meaningful improvements were seen across all PRO measures at week 6 with alixorexton, with improvements sustained through weeks 12-13.
Alixorexton was generally well tolerated across all doses tested throughout the six-week randomized double-blind treatment period and the seven-week open-label extension period. No serious treatment-emergent adverse events were reported. Most treatment-emergent adverse events were mild to moderate in severity.
The phase 2 study evaluated the safety and efficacy of alixorexton in adults with narcolepsy type 1. Participants were randomized to receive one of three doses of alixorexton, 4 mg, 6 mg or 8 mg, or placebo once daily for six weeks. The primary endpoint assessed change from baseline in mean sleep latency on the Maintenance of Wakefulness Test at week six, and secondary endpoints included change from baseline in Epworth Sleepiness Scale score, mean weekly cataplexy rate at week six, and incidence of adverse events.
Alixorexton, formerly referred to as ALKS 2680, is a novel, investigational, oral, selective orexin 2 receptor agonist in development for the treatment of narcolepsy type 1, narcolepsy type 2 and idiopathic hypersomnia. All participants in the double-blind portion of Vibrance-1 were eligible to continue to a seven-week open-label safety extension portion of the study, followed by a long-term safety study.