Alkermes Reports Positive ALKS 2680 Phase 1b Results for Narcolepsy Type 2 and Hypersomnia

April 9, 2024 — Alkermes plc has reported positive findings from a phase 1b study of ALKS 2680, an oral orexin 2 receptor agonist, in patients with narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH). The study showed that ALKS 2680 significantly improved mean sleep latency compared to placebo at all tested doses, with a clear dose-dependent effect. 

The drug was well tolerated, with all treatment-emergent adverse events being transient and mild in severity. In patients with NT2, ALKS 2680 treatment resulted in a mean increase in sleep latency of 12 minutes at the 5 mg dose, 19 minutes at the 12 mg dose, and 21 minutes at the 25 mg dose, compared to no change with placebo. At the higher doses, the mean sleep latency scores over an eight-hour period post-dose were within the normal range for healthy individuals. Similarly, in patients with IH, the mean increase in sleep latency was 8 minutes at the 5 mg dose, 11 minutes at the 12 mg dose, and 18 minutes at the 25 mg dose, compared to a two-minute reduction with placebo. The study also found that ALKS 2680 had no serious adverse effects or clinically meaningful changes in hepatic and renal parameters, vital signs, or electrocardiogram parameters. Alkermes plans to initiate a phase 2 study in NT2 patients in the second half of 2024. 

ALKS 2680 is a selective orexin 2 receptor agonist being developed as a once-daily treatment for narcolepsy. Orexin neuropeptides regulate the sleep/wake cycle, and loss of orexinergic neurons is associated with excessive daytime sleepiness and cataplexy in narcolepsy. ALKS 2680 is designed to address the underlying pathology of narcolepsy by improving wakefulness and providing cataplexy control. The phase 1 study of ALKS 2680 included single-ascending and multiple-ascending dose evaluations in healthy volunteers, as well as double-blind, cross-over treatment in patients with narcolepsy type 1 (NT1), NT2, and IH. The study assessed the safety, tolerability, pharmacokinetics, and pharmacodynamics of ALKS 2680. Alkermes expects to submit the phase 1b results for publication and present additional data at upcoming scientific meetings.

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