The study aims to enrol about 80 NT2 patients across the US, Australia, and Europe. Credit: Toa55/Shutterstock.

Alkermes has commenced the Phase II Vibrance-2 clinical trial of ALKS 2680 in adults with narcolepsy type 2 (NT2), a neurological condition marked by severe daytime drowsiness.

ALKS 2680 is an oral medication that selectively targets the orexin 2 receptor (OX2R) and is being developed for once-daily administration to treat narcolepsy.

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This randomised, double-blind, dose-ranging, placebo-controlled trial will compare the safety and efficacy of ALKS 2680 with placebo in adults with NT2.

Participants will be assigned to receive one of three doses of ALKS 2680 (10mg, 14mg, or 18mg) or a placebo once daily for eight weeks.

Determining if ALKS 2680 can significantly reduce sleepiness versus placebo, based on changes in mean sleep latency from the maintenance of wakefulness test (MWT) will be the trial’s primary endpoint.

Changes in Epworth Sleepiness Scale (ESS) scores and monitoring for adverse events are the secondary objectives.

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The study aims to enrol approximately 80 NT2 patients across the US, Europe and Australia.

Participants who complete the double-blind phase will have the option to join an open-label safety extension.

Additionally, the Phase II Vibrance-1 study is underway to assess ALKS 2680’s efficacy and safety in adults with narcolepsy type 1.

Alkermes research and development executive vice-president and chief medical officer Craig Hopkinson said: “We are pleased to initiate Vibrance-2, a Phase II clinical study for adults with narcolepsy type 2, based on the data from our Phase I, proof-of-concept study in this patient population.

“ALKS 2680 is the most advanced investigational orexin 2 receptor agonist currently in development for narcolepsy type 2.

“Across narcolepsy type 1 and narcolepsy type 2, significant unmet need remains, and we look forward to further characterising the efficacy and safety profile of ALKS 2680 in the Vibrance studies in both of these important patient populations.”