Alkermes presents first clinical data for ALKS 2680 in narcolepsy

Alkermes announced preliminary results, including initial proof-of-concept data, from a phase 1 study evaluating ALKS 2680, the company’s novel, investigational orexin 2 receptor agonist in development for the treatment of narcolepsy. The ongoing phase 1 study is evaluating the safety, tolerability, pharmacokinetics and pharmacodynamics of ALKS 2680 in healthy volunteers and patients with narcolepsy or idiopathic hypersomnia via once-daily, oral administration. Initial data from the single- and multiple-ascending dose evaluations in healthy volunteers and the first cohort of four patients with narcolepsy type 1 will be presented at the 2023 World Sleep Congress in Rio de Janeiro. Single administration of each dose strength of ALKS 2680 achieved statistically significant, clinically meaningful improvements compared to placebo in wakefulness. In the four patients with NT1, treatment with ALKS 2680 demonstrated improved sleep latency compared to placebo at all doses tested, with a clear dose response. The differences between ALKS 2680 and placebo were statistically significant for all doses. Treatment with ALKS 2680 resulted in clinically meaningful improvements in MWT from baseline at all doses tested. ALKS 2680 was generally well tolerated across all doses tested in the patients with NT1. There were no serious AEs or AEs leading to discontinuation. These data support further evaluation of ALKS 2680 as a potential treatment for narcolepsy.