Idiopathic hypersomnia is a chronic neurological sleep disorder marked by excessive daytime somnolence. Credit: PeopleImages.com – Yuri A / Shutterstock.
Irish biopharmaceutical company Alkermes has begun a randomised Phase II trial to assess the efficacy and safety of ALKS 2680 in adults with idiopathic hypersomnia (IH).
The double-blind, placebo-controlled Vibrance-3 trial is expected to enrol a total of around 96 IH patients across sites in Australia, Europe and the US.
Subjects will be randomised and given either 10mg, 14mg or 18mg of the therapy, or a placebo, once a day for eight weeks.
Alkermes said that based on the dose level, the trial’s primary endpoint will evaluate if the subjects taking the therapy experience a reduction in sleepiness against those who are taking only a placebo.
This will be determined as per the measure of changes in the Epworth Sleepiness Scale (ESS) score.
Subjects who complete the trial will be eligible to continue in an open-label, long-term safety trial.
Alkermes Research & Development executive vice-president and chief medical officer Craig Hopkinson said: “The initiation of Vibrance-3 represents an important step forward for the ALKS 2680 development programme as we seek to advance a potential new treatment option for people living with idiopathic hypersomnia.
“The Vibrance-3 Phase II study builds on encouraging data from our phase Ib, proof-of-concept study of ALKS 2680 in patients with IH, and we look forward to further characterising its safety and efficacy profile in this patient population.”
ALKS 2680 is an oral, selective orexin 2 receptor (OX2R) agonist being developed as a once-a-day treatment for narcolepsy type I and II, as well as IH–chronic, neurological conditions marked by ‘excessive’ daytime sleepiness.
The ongoing Phase II studies, Vibrance-1 and Vibrance-2, are assessing the therapy’s efficacy and safety in adults with narcolepsy type I and II respectively.
Last year, Alkermes announced positive topline data from the narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH) cohorts of a Phase Ib trial of ALKS 2680.
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