Alkermes : Initial ALKS 2680 Data Show Dose-Dependent, Improved Sleep Latency In Narcolepsy Type 1

(RTTNews) - Alkermes plc (ALKS) announced preliminary results from a phase 1 study evaluating ALKS 2680, the company's novel, investigational orexin 2 receptor or OX2R agonist in development for the treatment of narcolepsy. The initial ALKS 2680 data demonstrated dose-dependent, significantly improved sleep latency compared to placebo in Narcolepsy Type 1. ALKS 2680 was generally well tolerated at all doses tested.

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.

The patients with narcolepsy type 1 or NT1 were randomized to a crossover study in which each of them received 1 mg, 3 mg and 8 mg of ALKS 2680, and placebo, with washout periods between each treatment. Single administration of each dose strength of ALKS 2680 achieved statistically significant, clinically meaningful improvements compared to placebo in wakefulness, as measured by the maintenance of wakefulness test (MWT).

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. Following treatment with ALKS 2680, mean sleep latency in patients improved by 18 minutes, 30 minutes and 37 minutes from mean pre-treatment baseline sleep latency of three minutes at the 1 mg, 3 mg and 8 mg doses, respectively (least squares mean). Placebo treatment resulted in a one-minute reduction in mean sleep latency.

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