Alkermes to Present Positive Phase 1b ALKS 2680 Data in Narcolepsy Type 2 and Idiopathic Hypersomnia at Sleep Europe 2024

Alkermes plc has unveiled plans to present clinical data from its phase 1b study of ALKS 2680 at the European Sleep Research Society's 27th Congress, Sleep Europe 2024, happening from September 24-27, 2024, in Seville, Spain. ALKS 2680 is an investigational oral selective orexin 2 receptor (OX2R) agonist intended as a once-daily treatment for narcolepsy, a chronic neurological disorder characterized by excessive daytime sleepiness.

The company will present data related to narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH) from the phase 1b study. In an oral presentation and corresponding poster, results from NT2 patients (n=9) who received a single-dose oral administration of ALKS 2680 will be discussed. Additionally, data from IH patients (n=8) will be shared in a poster presentation. The study previously indicated that ALKS 2680 was generally well tolerated and improved wakefulness compared to placebo in both cohorts.

Ron Grunstein, M.D., Ph.D., Head of Sleep and Circadian Research at the Woolcock Institute of Medical Research, highlighted the potential of ALKS 2680 as a treatment for sleep disorders. Grunstein noted that the once-daily oral administration was generally well tolerated and improved wakefulness at all doses tested, supporting further clinical evaluation.

Alkermes will also present two posters detailing the study design and methods for the ongoing phase 2 studies, Vibrance-1 and Vibrance-2, which are evaluating ALKS 2680 in patients with narcolepsy type 1 and narcolepsy type 2, respectively.

Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes, emphasized the importance of these results for the ALKS 2680 phase 1b study. He stated that the data provides a strong foundation for advancing the ALKS 2680 phase 2 program and looks forward to sharing these findings with clinicians and researchers at the upcoming meeting.

Details of the presentations are as follows:

- "The Orexin 2 Receptor Agonist ALKS 2680 in Patients with Narcolepsy Type 2: An Initial Proof of Concept Phase 1b Study" presented by Ron Grunstein, M.D., Ph.D., on September 25, 2024, at 8:00 CEST, with a corresponding poster (P200) presented 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" presented by Brendon Yee, Ph.D., on September 26, 2024, 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" presented by Giuseppe Plazzi, M.D., Ph.D., on September 26, 2024, 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" presented by Sergey Yagoda, M.D., Ph.D., on September 26, 2024, from 17:30–18:45 CEST.

The phase 1 study of ALKS 2680 included evaluations in healthy volunteers and patients with NT1, NT2, and IH. The study involved single-ascending dose and multiple-ascending dose evaluations to assess safety, tolerability, pharmacokinetics, and pharmacodynamics.

ALKS 2680 aims to be a promising treatment for narcolepsy and other hypersomnolence disorders by targeting the orexin system, which plays a crucial role in regulating wakefulness. The drug has been previously evaluated in a phase 1 study and is currently undergoing further evaluation in phase 2 studies, Vibrance-1 and Vibrance-2.

Alkermes plc, a global biopharmaceutical company, is committed to developing innovative treatments for neurological disorders. The company has a range of products for conditions like alcohol dependence, opioid dependence, schizophrenia, and bipolar I disorder, along with a portfolio of investigational candidates for other neurological conditions, including narcolepsy.