Alkermes is preparing for the Vibrance-2 study, which is expected to begin in the latter half of 2024. Credit: Sai Thaw Kyar / Shutterstock.

Alkermes has commenced the Vibrance-1 Phase II clinical trial to evaluate ALKS 2680 in patients with narcolepsy type 1 (NT1).

ALKS 2680 is an investigational oral orexin 2 receptor (OX2R) agonist intended as a once-daily treatment for the chronic neurological disorder known for causing excessive daytime sleepiness.

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The Vibrance-1 study is a randomised, double-blind, placebo-controlled, dose-range-finding trial designed to assess ALKS 2680’s safety and efficacy in people with NT1.

It will involve participants receiving one of three doses of the therapy (4mg, 6mg or 8mg) or a placebo once daily for six weeks.

The primary goal is to measure the reduction in sleepiness among those taking ALKS 2680 compared to those on placebo, using the maintenance of wakefulness test (MWT).

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Secondary endpoints of the trial include changes in the Epworth Sleepiness Scale (ESS) score, mean weekly cataplexy rate (WCR), and adverse events incidence.

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The trial is set to enrol around 80 patients with NT1 across multiple sites in the US, Australia, and Europe.

Following the double-blind phase, participants will have the option to enter an open-label safety extension part of the trial.

Alkermes is also preparing for the Vibrance-2 study, a subsequent Phase II trial for patients with narcolepsy type 2 (NT2), which is expected to begin in the latter half of 2024.

ALKS 2680 has already been tested in a Phase I study involving healthy volunteers and individuals with various types of narcolepsy and idiopathic hypersomnia.

Alkermes Research & Development chief medical officer and executive vice-president Craig Hopkinson said: “ALKS 2680 offers the potential to harness the orexin system, the master regulator of wakefulness, by addressing the loss of orexin signalling common in people with narcolepsy type 1. Based on data from our Phase I proof-of-concept study, we are excited to advance this novel oral compound to Phase II.

“Initiation of the Vibrance-1 study is a significant milestone for the ALKS 2680 development programme, and we look forward to further characterising ALKS 2680’s safety and efficacy profile throughout this Phase II study.”

Earlier this month, Alkermes shared positive topline data from NT2  and idiopathic hypersomnia (IH) cohorts of a Phase Ib study of ALKS 2680.