Alkermes has shared positive topline data from the narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH) cohorts of a Phase Ib study of ALKS 2680 as a potential once-daily treatment for narcolepsy.
The study assessed the tolerability, safety, pharmacokinetics, and pharmacodynamics of ALKS 2680 given as a single daily oral dose.
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Nine patients with NT2 and eight with IH were enrolled in a four-way crossover study, where they received either 5mg, 12mg, or 25mg doses of ALKS 2680 and a placebo, with washout periods between treatments.
An investigational oral orexin 2 receptor (OX2R) agonist, ALKS 2680 demonstrated statistically significant improvements in mean sleep latency on the Maintenance of Wakefulness Test (MWT) from baseline, compared to a placebo, across all doses tested in the trial, with a clear dose response.
In addition, the therapy was found to be well tolerated in subject group populations at all doses tested.
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In NT2 patients, all treatment-emergent adverse events (TEAEs) were transient and self-resolving, with no serious adverse events (AEs) or discontinuations reported.
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By GlobalDataAlkermes plans to initiate a Phase II study for NT2 patients in the second half of this year.
The IH patient group also had TEAEs that were transient and self-resolving in nature.
Alkermes research and development chief medical officer and executive vice-president Craig Hopkinson said: “We’re pleased to share these topline results in patients with narcolepsy type 2 and idiopathic hypersomnia, which build upon our previously disclosed Phase Ib data in narcolepsy type 1.
“These data further validate our hypothesis that an orexin agonist with appropriate pharmaceutical properties has the potential to provide significant clinical benefits for both narcolepsy type 1 and type 2 patient populations.
“With these data now in hand, we are moving quickly to select doses for a Phase II study in narcolepsy type 2, which we plan to initiate in the second half of this year.”
