Alkermes’ Q3 update reveals progress for ALKS 2680, an orexin 2 receptor agonist aimed at treating narcolepsy and idiopathic hypersomnia, with phase 2 trial completions expected in 2025.

Summary: Alkermes’ third-quarter financial report highlights progress in developing orexin 2 receptor agonists, particularly ALKS 2680, aimed at treating narcolepsy types 1 and 2 as well as idiopathic hypersomnia. The company anticipates completing phase 2 studies by 2025, a milestone expected to lead into registrational trials. Recent updates include positive phase 1b data and plans for further studies in hypersomnolence disorders.

Key Takeaways:

ALKS 2680 Progress: Alkermes’ orexin 2 receptor agonist, ALKS 2680, is advancing in phase 2 studies, with results anticipated in 2025 for narcolepsy types 1 and 2 and idiopathic hypersomnia.
Strategic Focus: Alkermes views the orexin 2 receptor agonist as a transformational therapeutic area, with potential applications beyond hypersomnolence.
Shareholder Value: CEO Richard Pops emphasizes that ALKS 2680 and related orexin developments are central to driving Alkermes’ growth and shareholder value.

In its third-quarter financial report, Alkermes plc provided an update on its ongoing development of orexin 2 receptor agonists for the treatment of narcolepsy type 1 and 2 and idiopathic hypersomnia.

“Our third quarter financial results reflect strong year-over-year growth of our portfolio of proprietary commercial products and position us well to meet our strategic, operational and financial priorities for the year. Looking ahead, we believe growing our proprietary commercial products and advancing our pipeline, particularly ALKS 2680, our novel, investigational, orexin 2 receptor agonist, and additional orexin development candidates, will serve as the key drivers of shareholder value,” says Richard Pops, chief executive officer of Alkermes, in a release.

Pops adds, “2025 has the potential to be a transformational year for Alkermes as we expect to complete the ongoing phase 2 studies in narcolepsy type 1 and narcolepsy type 2 and prepare for potential registrational studies for ALKS 2680. With the potential to transform the treatment of hypersomnolence disorders, and with broad potential applicability across other symptomatic domains, orexin 2 receptor agonists represent one of the most exciting new therapeutic categories in development, and we believe a significant opportunity for Alkermes and our shareholders.”

Recent Highlights

In October 2024, the company hosted an investor event to review its portfolio of orexin 2 receptor agonists and development strategy. The company presented data from its ALKS 2680 phase 1b study in patients with narcolepsy type 1, narcolepsy type 2, and idiopathic hypersomnia, and discussed the study design for its ongoing phase 2 studies in narcolepsy type 1 and narcolepsy type 2. The company also announced its plans to initiate a phase 2 study in patients with idiopathic hypersomnia in 2025.
In September 2024, the company presented positive 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.
In August 2024, the company announced the initiation of its Vibrance-2 phase 2 study of ALKS 2680 in patients with narcolepsy type 2.
In August 2024, the company published its latest Corporate Responsibility Report, which details how the company integrates environmental, social, and governance considerations into its business. A copy of the report is available on the Responsibility section of Alkermes’ website.