In its financial report for the fourth quarter and full year ended Dec 31, 2023, Dublin, Ireland-based Alkermes announced it plans to initiate phase 2 trials for its orexin-2 receptor agonist, ALKS 2680, aimed at treating narcolepsy within the first half of the year.

The company recently completed the narcolepsy type 1 cohort in its phase 1b study of its investigational ALKS 2680. The data supported dose selection of 4 mg, 6 mg, and 8 mg once daily for the planned phase 2 study in narcolepsy type 1.

“We entered 2024 as a pure-play neuroscience company and are well positioned to deliver on our strategic priorities to drive growth of our proprietary commercial products, advance the clinical development of ALKS 2680 for the treatment of narcolepsy, and generate significant cash flow,” says Richard Pops, chief executive officer of Alkermes, in a release. 

Regarding ALKS 2680, Brendon Yee, PhD, professor of respiratory and sleep physician at the Woolcock Institute of Medical Research, says in an earlier release, “The early proof-of-concept and safety data we’ve seen in this ongoing phase 1 study of ALKS 2680 in both healthy volunteers and four patients with narcolepsy type 1 are compelling. These data support further evaluation of ALKS 2680 as a potential treatment for narcolepsy. Orexin-2 receptor agonists such as ALKS 2680 represent an exciting new class of potential treatments for narcolepsy, with the opportunity to transform the treatment paradigm for people living with this disease.”

Other highlights for the fourth quarter included that, in December 2023, the company had entered into a definitive agreement to sell its development and manufacturing facility in Athlone, Ireland, to Novo Nordisk. Under the terms of the agreement, upon closing of the transaction, Alkermes will be entitled to a one-time cash payment of $92.5 million for the facility and related assets, subject to customary adjustments in accordance with the agreement. The transaction is expected to close in mid-2024, subject to certain closing conditions.

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