Announcement • Aug 25

Alkermes plc Publishes Data From Vibrance-1 Phase 2 Study Of Alixorexton In Adults With Narcolepsy Type 1

Alkermes plc announced the publication of data from the Vibrance-1 phase 2 study of alixorexton in adults with narcolepsy type 1 (NT1) in The Lancet Neurology. Alixorexton is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development for the treatment of NT1, narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH). Based on the positive results demonstrated by alixorexton in the phase 2 Vibrance Studies in NT1 and NT2, Alkermes has initiated the Brilliance Studies, a global phase 3 program evaluating once-daily and split dose regimens of alixorexton in adults with NT1 and NT2. The phase 2 Vibrance-1 study was conducted in 92 adults with NT1 and included a six-week, randomized, placebo-controlled, double-blind period followed by an optional seven-week open-label extension. Treatment with once-daily alixorexton led to statistically significant improvements from baseline versus placebo in both objective and subjective measures of excessive daytime sleepiness, as measured by the Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS), respectively. All dose groups (4 mg, 6 mg and 8 mg) achieved mean sleep latency values within the normative range on the MWT (i.e., =20 minutes) and ESS (a score of =10) at week six. Weekly cataplexy rate was significantly decreased versus placebo in the 6 mg alixorexton group. Alixorexton also demonstrated clinically meaningful improvements on exploratory patient-reported endpoints assessing overall disease severity, fatigue, cognition and health-related quality of life. Alixorexton treatment was generally well tolerated, with most treatment-emergent adverse events (TEAEs) being mild to moderate in severity, and no serious TEAEs. Vibrance-1 was a phase 2, randomized, double-blind, dose-range-finding, placebo-controlled study evaluating the safety and efficacy of alixorexton in adults with narcolepsy type 1 (NT1). Participants (n=92) were randomized to receive one of three doses of alixorexton (4 mg, 6 mg or 8 mg) or placebo to be taken once-daily for six weeks. The primary endpoint assessed whether participants taking alixorexton experienced an improvement in wakefulness compared to participants taking placebo, as measured by the change from baseline in mean sleep latency on the Maintenance of Wakefulness Test (MWT) at week six. Secondary endpoints included change from baseline in Epworth Sleepiness Scale (ESS) score at week six, mean weekly cataplexy rate (WCR) at week six, and incidence of adverse events. The study also included a number of exploratory patient-reported outcome measures, which evaluated the effect of alixorexton on participants’ disease severity, fatigue and cognition. All participants in the double-blind portion of the study were eligible to continue to a seven-week open-label safety extension portion of the study, followed by a long-term safety study. Alixorexton (formerly referred to as ALKS 2680) is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development for the treatment of narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH). Orexin, a neuropeptide produced in the lateral hypothalamus, is considered to be the master regulator of wakefulness due to its activation of multiple, downstream wake-promoting pathways that project widely throughout the brain. Targeting the orexin system may address excessive daytime sleepiness across hypersomnolence disorders, whether or not deficient orexin signaling is the underlying cause of disease. Alixorexton is currently being evaluated in the phase 3 Brilliance Studies in patients with NT1 and NT2, and in the phase 2 Vibrance-3 study in patients with IH. The U.S. Food and Drug Administration (FDA) has granted alixorexton Breakthrough Therapy designation for the treatment of NT1 and Orphan Drug Designation (ODD) for the treatment of IH. The European Commission has granted ODD to alixorexton for the treatment of narcolepsy. ESS: 8-item self-administered questionnaire that measures severity of excessive daytime sleepiness across multiple conditions over the past 7 days (=10 = normative). Weekly cataplexy rate was derived at Week 6 from patients’ cataplexy diaries over Weeks 5 and 6.

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