Alkermes will present data from a phase 1b study, details of a phase 2 trial, and patient impact interviews for its investigational narcolepsy treatment, ALKS 2680, at SLEEP 2024.


Summary: Alkermes plc announced plans to present three posters at SLEEP 2024, showcasing the potential benefits of its investigational orexin 2 receptor agonist, ALKS 2680, for narcolepsy treatment. Presentations will include data from a phase 1b study, the design of the phase 2 Vibrance-1 trial, and insights from patient interviews highlighting the impact of narcolepsy on daily life.

Key Takeaways: 

  • Phase 1b Study Data: The phase 1b study evaluated the safety and efficacy of a single-dose oral administration of ALKS 2680 in patients with narcolepsy type 1, using both objective and subjective measures.
  • Vibrance-1 Trial Design: The phase 2 Vipbrance-1 trial will assess the safety and efficacy of ALKS 2680 in a larger cohort of patients with narcolepsy type 1, compared to a placebo.
  • Patient Interviews: Qualitative interviews with patients with narcolepsy types 1 and 2 revealed the extensive impact of the condition on various aspects of their lives, including work, school, mental health, daily activities, and relationships.

Alkermes plc announced plans to present three posters related to ALKS 2680—the company’s novel, investigational, oral orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for narcolepsy—at SLEEP 2024 in Houston. 

The company will present two posters during a late-breaking abstract session:

  • Data from the full cohort of patients (n=10) with narcolepsy type 1 from the phase 1b, a proof-of-concept study evaluating single-dose oral administration of ALKS 2680. Safety results and pharmacodynamic efficacy assessments evaluating objective (Maintenance of Wakefulness Test) and subjective patient-reported (Karolinska Sleepiness Scale) measures of sleepiness will be presented.
  • Study design and methods for the Vibrance-1 study, a recently initiated phase 2 clinical trial evaluating the safety and efficacy of ALKS 2680 compared to placebo in patients with narcolepsy type 1. 

In addition, findings from in-depth, qualitative interviews with patients with narcolepsy type 1 (n=12) and narcolepsy type 2 (n=10) will be presented. During the 60-minute interviews, participants described the impact and burden of disease on many facets of their lives, including work and school activities, mental health, activities of daily living, and relationships.

“We have made significant progress in the ALKS 2680 program in the last year, including generating proof-of-concept data that validated our design hypothesis and enabled us to initiate our Vibrance-1 phase 2 study in patients with narcolepsy type 1,” says Craig Hopkinson, MD, chief medical officer and executive vice president of research and development at Alkermes, in a release. “We are excited to present data from the full narcolepsy type 1 cohort from our phase 1b study and qualitative findings that bring to light new insights from patients that demonstrate the breadth of impacts narcolepsy can have on patients’ lives. We look forward to engaging with the sleep community at this important scientific meeting.”

Study Details

Details of Alkermes’ presentations at SLEEP 2024 are as follows:

“Safety and pharmacodynamic effects of the orexin 2 receptor agonist ALKS 2680 in patients with narcolepsy type 1: a first-in-human phase 1 study”

  • Abstract ID: 1323
  • Poster board number: 423
  • Presenter: Ron Grunstein, MD, PhD, head of sleep and circadian research at the Woolcock Institute of Medical Research
  • Presentation date: The poster will be presented on Tuesday, June 4, from 10–10:45 am CT, during session P-31.

“Vibrance-1: Study design and methods for a phase 2, randomized, placebo-controlled, parallel group study evaluating the safety and efficacy of ALKS 2680 in patients with narcolepsy type 1”

  • Abstract ID: 1363
  • Poster board number: 462
  • Presenter: David T. Plante, MD, PhD, Associate Professor of Psychiatry at the University of Wisconsin-Madison
  • Presentation date: The poster will be presented on Tuesday, June 4, from 11–11:45 am CT, during session P-31.

“The burden of living with narcolepsy: patient perspectives from in-depth qualitative interviews”

  • Abstract ID: 673
  • Poster board number: 302
  • Presenter: Michael J. Doane, PhD, Alkermes
  • Presentation date: The poster will be presented on Wednesday, June 5, from 11–11:45 am CT, during session P-42.

Photo 194238729 © Olan Dah | Dreamstime.com