Alkermes to present phase 2 Vibrance-1 data on Alixorexton in narcolepsy type 1 at World Sleep 2025

Alkermes announced plans to present detailed results from its Vibrance-1 phase 2 study evaluating alixorexton in patients with narcolepsy type 1 (NT1) at World Sleep Congress, taking place Sept. 5-10, 2025 in Singapore, and in an investor webcast presentation hosted by the company. Alixorexton, formerly referred to as ALKS 2680, is the company’s 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).

“We are honored to welcome leading researchers and clinicians from the global sleep medicine community to World Sleep Singapore 2025 Congress, where groundbreaking research in narcolepsy will be presented,” said Raffaele Ferri, M.D., President of World Sleep Society. “We are looking forward to the presentation of new datasets on orexin 2 receptor agonists in development, as well as other innovative updates across the field of sleep medicine. I am encouraged by the continued interest and commitment from the global research community to improve the standard of care for people living with central disorders of hypersomnolence.”

Following the recent announcement of positive topline results from Vibrance-1, the company plans to present additional details from this phase 2 study in three oral presentations. In addition, the company will present a poster outlining the study design and methods for Vibrance-3, a phase II clinical study evaluating the safety and efficacy of alixorexton compared to placebo in patients with IH.

“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,” said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President, Research & Development at Alkermes. “We look forward to sharing detailed data from our Vibrance-1 phase 2 study with clinicians at World Sleep. Along with important new findings related to improvements in fatigue and cognitive impairment – disruptive symptoms that impact patients’ day-to-day lives – the efficacy, tolerability and safety data from Vibrance-1 will be presented, providing an overview of the differentiating features of once-daily alixorexton across a range of doses in patients with narcolepsy type 1.”

 

Oral presentations
The following presentations will take place during the Targeting the orexin pathway: Emerging pharmacotherapies for narcolepsy type 1 session taking place on Monday, Sept. 8, 2025 (3:15– 4:46 p.m. SGT; 3:15– 4:46 a.m. ET):

Vibrance-1: A Randomized Phase 2 Study Evaluating Safety and Efficacy of the Orexin 2 Receptor Agonist Alixorexton (ALKS 2680) in Patients with Narcolepsy Type 1

• Presenter: Giuseppe Plazzi, M.D., Ph.D., Neurologist, Director of the Narcolepsy Center at the IRCCS of the Neurological Sciences of Bologna and Professor of Childhood Neuropsychiatry at the University of Modena and Reggio Emilia.

Improvement in the Severity of Narcolepsy Symptoms and Fatigue in Patients with Narcolepsy Type 1 Treated with the Orexin 2 Receptor Agonist Alixorexton (ALKS 2680)

• Presenter: Yves Dauvilliers, M.D., Ph.D., Director, Sleep-Wake Disorders Center, Department of Neurology, Gui de Chauliac Hospital, Montpellier, France.

Improvement in Patient-reported Cognitive Functioning in Patients with Narcolepsy Type 1 Treated with the Orexin 2 Receptor Agonist Alixorexton (ALKS 2680)

• Presenter: Giuseppe Plazzi, M.D., Ph.D., Neurologist, Director of the Narcolepsy Center at the IRCCS of the Neurological Sciences of Bologna and Professor of Childhood Neuropsychiatry at the University of Modena and Reggio Emilia.

 

Poster Presentation
A Phase 2, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of ALKS 2680 in Patients With Idiopathic Hypersomnia: Study Design and Methods for Vibrance-3

• Poster Board Number: 169
• Presenter: Marcus Yountz, M.D., Alkermes
• Presentation Date: The poster will be presented on Tuesday, Sept. 9, 2025 from 4:45 – 5:45 p.m. SGT as part of poster abstract group 3.