Alkermes Presents First Clinical Data for Orexin 2 Receptor Agonist ALKS 2680 at World Sleep Congress
DUBLIN, Oct. 23, 2023 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today 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 (OX2R) 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 (NT1) will be presented today at the 2023 World Sleep Congress in Rio de Janeiro.
- 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: 1 mg (p
- Treatment with ALKS 2680 resulted in clinically meaningful improvements in MWT from baseline at all doses tested.
- "These initial data support our design rationale for ALKS 2680 as a highly potent, orally bioavailable, selective orexin 2 receptor agonist designed to address the underlying pathology of narcolepsy.