Alkermes to Showcase Phase 2 Vibrance-1 Data on Alixorexton at World Sleep Congress 2025

Alkermes plc (Nasdaq: ALKS) will present detailed results from its Vibrance-1 Phase 2 study of alixorexton in narcolepsy type 1 (NT1) at the World Sleep Congress, held Sept. 5–10, 2025 in Singapore.

Alixorexton (formerly ALKS 2680) is an investigational, oral, selective orexin 2 receptor (OX2R) agonist. It is in Phase 2 development as a once-daily therapy for NT1, narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH).

World Sleep Society Perspective

Dr. Raffaele Ferri, President of the World Sleep Society, said:

“We welcome leading researchers to Singapore, where groundbreaking work in narcolepsy will be presented. Orexin 2 receptor agonists represent a promising frontier in sleep medicine.”

He emphasized the community’s commitment to advancing care for people with central disorders of hypersomnolence.

Focus on Vibrance-1 Findings

Following positive topline results, Alkermes will share three oral presentations from Vibrance-1. These will cover:

• Efficacy and safety outcomes across dosing levels.
• Improvements in fatigue and cognitive function, two disruptive symptoms in NT1.
• Differentiating features of once-daily alixorexton compared with placebo.

Craig Hopkinson, M.D., Chief Medical Officer of Alkermes, noted:

“Substantial new datasets will highlight alixorexton’s potential across symptoms that impact daily life, including wakefulness, fatigue, and cognition.”

Oral Presentations – Sept. 8, 2025

Session: Targeting the Orexin Pathway: Emerging Pharmacotherapies for Narcolepsy Type 1
Time: 3:15–4:46 p.m. SGT (3:15–4:46 a.m. ET)

• Vibrance-1 Phase 2 Study: Safety and Efficacy
  Presenter: Dr. Giuseppe Plazzi, Neurologist, Director of the Narcolepsy Center, Bologna.
• Symptom and Fatigue Improvements with Alixorexton
  Presenter: Dr. Yves Dauvilliers, Director, Sleep-Wake Disorders Center, Montpellier, France.
• Patient-Reported Cognitive Function Improvements
  Presenter: Dr. Giuseppe Plazzi, Bologna and University of Modena.

Poster Presentation – Sept. 9, 2025

• Study Design and Methods for Vibrance-3 (Idiopathic Hypersomnia)
  Presenter: Dr. Marcus Yountz, Alkermes.
• Poster Board #169 | Time: 4:45–5:45 p.m. SGT.

Vibrance-3 is a Phase 2, placebo-controlled study of alixorexton in IH.

Investor Webcast – Sept. 8, 2025

Alkermes will host a webcast and conference call with slides:

• Time: 8:00 a.m. ET (8:00 p.m. SGT).
• Access: Alkermes Investor Site.
• Dial-in: +1 877-407-2988 (U.S.) | +1 201-389-0923 (International).
• Replay: Available online for 30 days.

About the Vibrance-1 Study

• Design: Phase 2, randomized, double-blind, placebo-controlled.
• Participants: 92 adults with NT1.
• Treatment: Once-daily alixorexton (4, 6, or 8 mg) or placebo for six weeks.
• Primary Endpoint: Change in wakefulness on the Maintenance of Wakefulness Test (MWT) at week six.
• Secondary Endpoints: Epworth Sleepiness Scale score, cataplexy rates, and safety outcomes.
• Exploratory Measures: Patient-reported disease severity, fatigue, and cognition.
• Extension: Seven-week open-label safety study plus a long-term follow-up.

About Alixorexton

Alixorexton is a novel OX2R agonist designed for once-daily oral dosing. Orexin, produced in the lateral hypothalamus, regulates wakefulness by activating downstream brain pathways. Targeting this system could improve excessive daytime sleepiness across multiple hypersomnolence disorders.

Alixorexton has been studied in healthy volunteers and patients with NT1, NT2, and IH. It is under evaluation in the Phase 2 Vibrance-1, Vibrance-2, and Vibrance-3 trials.

About Alkermes

Alkermes plc is a global biopharma company headquartered in Ireland with R&D in Massachusetts and manufacturing in Ohio.

The company develops treatments for alcohol and opioid dependence, schizophrenia, and bipolar I disorder. Its pipeline includes therapies for narcolepsy and idiopathic hypersomnia.

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