Alkermes to Present Vibrance-1 Narcolepsy Study Results at World Sleep Congress.

Alkermes plans to present detailed results from the Vibrance-1 study evaluating alixorexton in narcolepsy type 1 patients at World Sleep Congress. The results will cover primary and secondary efficacy and safety measures, as well as patient-reported outcomes related to disease severity, fatigue, and cognition. The company will host an investor webcast on September 8 at 8:00 a.m. ET to discuss the findings. Alixorexton is a novel, oral, selective orexin 2 receptor agonist in phase 2 development for narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia.

Alkermes plc (Nasdaq: ALKS) is set to present detailed results from its Vibrance-1 phase 2 study evaluating alixorexton in patients with narcolepsy type 1 (NT1) at the World Sleep Congress, taking place from September 5-10, 2025, in Singapore. The company will share findings from the study, including primary and secondary efficacy and safety measures, as well as patient-reported outcomes related to disease severity, fatigue, and cognition. The presentation will occur during the Targeting the orexin pathway: Emerging pharmacotherapies for narcolepsy type 1 session on Monday, September 8, 2025, at 3:15-4:46 p.m. SGT (3:15-4:46 a.m. ET). Additionally, the company will host an investor webcast on Monday, September 8, 2025, at 8:00 a.m. ET, to discuss the study's findings.

The Vibrance-1 study, which is a phase 2, randomized, double-blind, dose-range-finding, placebo-controlled trial, evaluated the safety and efficacy of alixorexton in adults with NT1. Participants were randomized to receive one of three doses of alixorexton (4 mg, 6 mg, or 8 mg) or placebo, taken once-daily for six weeks. The primary endpoint assessed whether participants taking alixorexton experienced an improvement in wakefulness compared to those 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 changes in the Epworth Sleepiness Scale (ESS) score at week 6 and the mean weekly cataplexy rate (WCR) at weeks five and six, as well as the incidence of adverse events. The study also included exploratory patient-reported outcome measures evaluating the effect of alixorexton on participants' disease severity, fatigue, and cognition.

Alixorexton, formerly known as ALKS 2680, is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in phase 2 development as a once-daily treatment for NT1, narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH). Orexin, a neuropeptide produced in the lateral hypothalamus, is considered 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.

Alkermes will also present a poster outlining the study design and methods for Vibrance-3, a phase 2 clinical study evaluating the safety and efficacy of alixorexton compared to placebo in patients with IH. The poster will be presented on Tuesday, September 9, 2025, from 4:45-5:45 p.m. SGT as part of poster abstract group 3.

The company's Chief Medical Officer and Executive Vice President, Research & Development, Craig Hopkinson, M.D., stated, "Substantial new datasets from the leading orexin 2 receptor agonists in development will be presented at this year's World Sleep Congress, representing an important milestone in understanding the broad implications of orexin biology as we seek to transform the treatment of narcolepsy."

References:
[1] https://www.prnewswire.co.uk/news-releases/alkermes-to-present-detailed-positive-results-from-vibrance-1-phase-2-study-evaluating-alixorexton-in-patients-with-narcolepsy-type-1-at-world-sleep-2025-302537271.html