Summary: Alkermes plc is set to present data from its phase 1b study of ALKS 2680, a novel oral orexin 2 receptor agonist, at Sleep Europe 2024. The study evaluated ALKS 2680 in patients with narcolepsy type 2 and idiopathic hypersomnia, showing improved wakefulness compared to placebo. The company will also discuss the design of its ongoing phase 2 studies, Vibrance-1 and Vibrance-2, aimed at further evaluating ALKS 2680 in patients with narcolepsy types 1 and 2.
Three Key Takeaways:
- ALKS 2680 Shows Promising Results: The phase 1b data showed that ALKS 2680 improved wakefulness in patients with narcolepsy type 2 and idiopathic hypersomnia, with the drug generally well tolerated.
- Phase 2 Studies Underway: Alkermes will present the designs of its phase 2 trials, Vibrance-1 and Vibrance-2, which are focused on further evaluating the safety and efficacy of ALKS 2680 in patients with narcolepsy types 1 and 2.
- Global Research Presentation: The data will be presented at the European Sleep Research Society’s 27th Congress, Sleep Europe 2024.
Alkermes plc announced plans to present clinical data from its phase 1b study of ALKS 2680 in patients with narcolepsy type 2 and idiopathic hypersomnia at the European Sleep Research Society’s 27th Congress, Sleep Europe 2024, taking place Sep. 24-27 in Seville, Spain.
ALKS 2680 is the company’s novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for narcolepsy, a chronic, neurological disorder characterized by excessive daytime sleepiness.
In an oral presentation and corresponding poster presentation, the company will share data from the cohort of patients with narcolepsy type 2 (n=9) from a phase 1b, proof-of-concept study evaluating single-dose, oral administration of ALKS 2680. Additionally, the company will present a poster with data from the cohort of patients with idiopathic hypersomnia (n=8) from the same study. As previously announced, ALKS 2680 was generally well tolerated with improved wakefulness compared to placebo in both cohorts.
“Results from the ALKS 2680 phase 1b proof-of-concept study in patients with narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia highlight the potential of ALKS 2680 as a treatment option for people living with these sleep disorders, both with and without known orexin deficiency. Treatment with once-daily, oral ALKS 2680 was generally well tolerated with improved wakefulness compared to placebo at all doses tested across all three patient populations, supporting further clinical evaluation,” says Ron Grunstein, MD, PhD, head of sleep and circadian research at the Woolcock Institute of Medical Research, in a release.
The company will also present two posters at Sleep Europe 2024 detailing the study design and methods for each of the ongoing phase 2 studies, Vibrance-1 and Vibrance-2, evaluating ALKS 2680 in patients with narcolepsy type 1 and narcolepsy type 2, respectively.
“We’re pleased to share the results from our ALKS 2680 phase 1b, proof-of-concept study in patients with narcolepsy type 2 and idiopathic hypersomnia at Sleep Europe 2024. These data provide further evidence of the clinical profile of ALKS 2680 in patients with sleep disorders and a strong foundation to advance the ALKS 2680 phase 2 program,” says Craig Hopkinson, MD, chief medical officer and executive vice president of research and development at Alkermes, in a release. “We look forward to engaging with clinicians and researchers at this important meeting, sharing the data from our clinical development program, and discussing the design of the ongoing phase 2 studies, Vibrance-1 and Vibrance-2, which are evaluating ALKS 2680 in patients with narcolepsy type 1 and type 2, respectively.”
Sleep Europe 2024 Presentations
Details of Alkermes’ presentations at Sleep Europe 2024 are as follows:
- The Orexin 2 Receptor Agonist ALKS 2680 in Patients with Narcolepsy Type 2: An Initial Proof of Concept Phase 1b Study
- Presenter: Ron Grunstein, MD, PhD, head of sleep and circadian research at the Woolcock Institute of Medical Research
- Presentation date: The oral presentation is scheduled to occur on Wednesday, Sept 25, at 8 CEST as part of Oral Session 1 and will be available online to registered attendees. The corresponding poster (P200) will be presented on Wednesday, Sept 25, from 16:00–17:45 CEST.
- The Orexin 2 Receptor Agonist ALKS 2680 in Patients with Idiopathic Hypersomnia: An Initial Proof of Concept Phase 1b Study
- Poster ID: P5070
- Presenter: Brendon Yee, PhD, professor and respiratory and sleep physician at the Woolcock Institute of Medical Research
- Presentation date: The poster will be presented on Thursday, Sept 26, from 17:30–18:45 CEST.
- Vibrance-1: Study Design and Methods for a Phase 2, Randomised, Placebo-Controlled, Parallel Group Study Evaluating the Safety and Efficacy of ALKS 2680 in Patients With Narcolepsy Type 1
- Poster ID: P797
- Presenter: Giuseppe Plazzi, MD, PhD, head of the sleep center at the Institute of Neurological Sciences of Bologna, Italy, and chair of child neurology at the University of Modena and Reggio Emilia
- Presentation Date: The poster will be presented on Thursday, Sept 26, from 17:30–19:00 CEST.
- Vibrance-2: Study Design and Methods for a Phase 2, Randomised, Placebo-Controlled, Parallel Group Study Evaluating the Safety and Efficacy of ALKS 2680 in Patients With Narcolepsy Type 2
- Poster ID: P5071
- Presenter: Sergey Yagoda, MD, PhD, Alkermes
- Presentation Date: The poster will be presented on Thursday, Sept 26, from 17:30–18:45 CEST.
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