Alkermes Unveils Promising Findings on Alixorexton at World Sleep 2025

Alkermes Presenting Exciting Findings on Alixorexton at World Sleep 2025

Alkermes plc (Nasdaq: ALKS) has announced its upcoming presentation of detailed findings from the Vibrance-1 phase 2 study regarding alixorexton at the World Sleep Congress scheduled for September 5-10, 2025, in Singapore. The study focuses on patients with narcolepsy type 1 (NT1), showcasing significant developments in this area of sleep medicine.

Alixorexton, previously known as ALKS 2680, is an innovative oral medication designed to selectively activate orexin 2 receptors. This treatment aims to revolutionize the management of narcolepsy, particularly NT1, and narcolepsy type 2 (NT2) as well as idiopathic hypersomnia (IH). As Dr. Raffaele Ferri, President of the World Sleep Society, expressed, the congress will highlight extraordinary research contributions in the field of narcolepsy, making it a pivotal moment for global sleep medicine.

The Vibrance-1 study demonstrated promising topline results, and Alkermes plans to share comprehensive data through three oral presentations during the congress. The presentations will cover various dimensions including the efficacy and safety of alixorexton, as well as exploratory results that assess patient-reported outcomes focusing on disease severity, fatigue, and cognitive function.

Breaking down the Vibrance-1 Study

The Vibrance-1 phase 2 study (NCT06358950) was meticulously structured as a randomized, double-blind, placebo-controlled trial involving 92 adult participants diagnosed with NT1. Subjects were administered varying doses of alixorexton (4 mg, 6 mg, or 8 mg) or a placebo once daily over a six-week duration. The primary objective was to determine whether those taking alixorexton exhibited enhanced wakefulness compared to the placebo group, specifically measured through their performance in the maintenance of wakefulness test (MWT) after six weeks.

Key secondary endpoints included shifts in the Epworth Sleepiness Scale (ESS) scores and the weekly incidence of cataplexy, as well as tracking potential adverse events. Notably, the study also included exploratory measures evaluating the impact of alixorexton on fatigue and cognitive impairment, pivotal aspects that heavily influence the quality of daily life for patients.

Alkermes anticipates that these presentations will deepen the understanding of treatment outcomes for narcolepsy, addressing critical symptoms such as fatigue and cognitive difficulties. Dr. Craig Hopkinson, the Chief Medical Officer and Executive Vice President of Research and Development at Alkermes, emphasized the presentation of substantial new insights and data that will spotlight the transformative potential of orexin receptor biology in treating narcolepsy.