Alkermes plc (NASDAQ:ALKS) today announced new data from the full narcolepsy type 1 (NT1) cohort of a phase 1b, proof-of-concept study evaluating ALKS 2680, the company's novel, investigational, oral orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for narcolepsy. The data are being presented at SLEEP 2024, the 38th annual meeting of the Associated Professional Sleep Societies (APSS), taking place June 1-5, 2024 in Houston.
The phase 1b study evaluated the safety, tolerability, pharmacokinetics and pharmacodynamics of ALKS 2680 via once-daily, single, oral administration. Ten patients with NT1 were randomized1 to one of four crossover sequences in which each participant received 1 mg, 3 mg and 8 mg of ALKS 2680, and placebo, with washout periods between each treatment. Initial results from the first four patients in this NT1 cohort were previously presented at the 2023 World Sleep Congress.