Alkermes to Present ALKS 2680 Data at SLEEP 2024

Alkermes plc, a global biopharmaceutical company, has announced its intention to present three significant posters at SLEEP 2024, the 38th annual meeting of the Associated Professional Sleep Societies (APSS). This event is scheduled to take place from June 1-5, 2024, in Houston. The presentations will focus on ALKS 2680, an investigational oral orexin 2 receptor (OX2R) agonist that is being developed as a once-daily treatment for narcolepsy.

The first poster will feature data from a phase 1b proof-of-concept study, which involved a cohort of ten patients with narcolepsy type 1 (NT1). This study evaluated the safety and pharmacodynamic efficacy of a single dose of ALKS 2680. The assessments included objective measures like the Maintenance of Wakefulness Test (MWT) and subjective patient-reported outcomes using the Karolinska Sleepiness Scale (KSS).

The second poster will detail the design and methods of the Vibrance-1 study, a phase 2 clinical trial recently initiated to evaluate the safety and efficacy of ALKS 2680 in comparison to a placebo in NT1 patients.

Additionally, findings from qualitative interviews with twelve NT1 patients and ten patients with narcolepsy type 2 (NT2) will be presented. These one-hour interviews explored the wide-ranging impacts of narcolepsy on various aspects of life, including work, education, mental health, daily activities, and interpersonal relationships.

Dr. Craig Hopkinson, Chief Medical Officer and Executive Vice President of Research & Development at Alkermes, expressed enthusiasm about the progress in the ALKS 2680 program over the past year. He highlighted the significance of the proof-of-concept data, which validated the initial design hypothesis and led to the commencement of the Vibrance-1 phase 2 study. Dr. Hopkinson highlighted the importance of the qualitative findings, which provide new insights into the extensive impact of narcolepsy on patients' lives. He looks forward to engaging with the sleep research community at this pivotal scientific meeting.

The presentations scheduled at SLEEP 2024 are as follows:

1. "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" will be presented by Dr. Ron Grunstein from the Woolcock Institute of Medical Research. This poster (Abstract ID: 1323, Poster Board Number: 423) will be showcased on Tuesday, June 4, 2024, from 10:00–10:45 a.m. CT during session P-31.

2. "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" will be presented by Dr. David T. Plante from the University of Wisconsin-Madison. This poster (Abstract ID: 1363, Poster Board Number: 462) will be displayed on Tuesday, June 4, 2024, from 11:00–11:45 a.m. CT, also during session P-31.

3. "The Burden of Living with Narcolepsy: Patient Perspectives from In-Depth Qualitative Interviews" will be presented by Dr. Michael J. Doane from Alkermes. This poster (Abstract ID: 673, Poster Board Number: 302) will be available on Wednesday, June 5, 2024, from 11:00–11:45 a.m. CT during session P-42.

ALKS 2680 aims to address narcolepsy's underlying pathology by improving wakefulness and managing cataplexy. Previously evaluated in a phase 1 study involving healthy volunteers and individuals with NT1, NT2, and idiopathic hypersomnia, ALKS 2680 is now undergoing a phase 2 evaluation in NT1 patients.

The Vibrance-1 study is a double-blind, randomized, placebo-controlled, dose-range-finding trial assessing ALKS 2680's safety and efficacy in NT1 patients.

Alkermes plc is committed to developing innovative treatments for neurological conditions, including narcolepsy. The company's headquarters are in Ireland, with additional offices and facilities in Massachusetts and Ohio.