The phase 2 clinical trial will evaluate the safety and efficacy of ALKS 2680, an oral treatment designed to address orexin signaling deficiencies in patients with narcolepsy type 1.


Summary: Alkermes plc has launched the Vibrance-1 study, a phase 2 clinical trial to assess the safety and efficacy of ALKS 2680, a novel orexin-2 receptor agonist, in treating narcolepsy type 1. This oral treatment aims to improve wakefulness by targeting the orexin system, which is often deficient in narcolepsy patients. The double-blind, placebo-controlled study will test three dosages over six weeks across multiple international sites, with participants having the option to continue in an open-label extension. A subsequent phase 2 trial, Vibrance-2, is planned for narcolepsy type 2.

Key Takeaways: 

  • Alkermes has begun the Vibrance-1 study, a phase 2 trial to evaluate the safety and efficacy of ALKS 2680, a novel orexin-2 receptor agonist, in patients with narcolepsy type 1.
  • The trial is randomized, double-blind, and placebo-controlled, assessing three doses of ALKS 2680 taken once daily over six weeks. It aims to measure improvements in sleep latency and cataplexy rates among participants.
  • The study will enroll approximately 80 patients at sites in the United States, Australia, and Europe, with all participants eligible for an open-label safety extension. Alkermes also plans to initiate a second phase 2 study, Vibrance-2, for narcolepsy type 2 in the second half of 2024.

Alkermes plc announced that it has initiated the Vibrance-1 study, a phase 2 clinical trial evaluating the safety and efficacy of ALKS 2680 compared to placebo in patients with narcolepsy type 1. 

ALKS 2680 is the company’s novel, investigational, oral orexin-2 receptor agonist in development as a once-daily treatment for narcolepsy, a chronic, neurological disorder characterized by excessive daytime sleepiness. Narcolepsy type 1 is associated with an absence or significant deficiency in orexin levels, and the presence of cataplexy, a sudden loss of muscle tone triggered by strong emotions.

“ALKS 2680 offers the potential to harness the orexin system, the master regulator of wakefulness, by addressing the loss of orexin signaling common in people with narcolepsy type 1. Based on data from our phase 1, proof-of-concept study, we are excited to advance this novel oral compound to phase 2,” says Craig Hopkinson, MD, chief medical officer and executive vice president of research and development at Alkermes, in a release.

Vibrance-1 Trial to Test Efficacy of Narcolepsy Drug Candidate

Vibrance-1 is a phase 2, randomized, double-blind, dose-range-finding, placebo-controlled study evaluating the safety and efficacy of ALKS 2680 in people with narcolepsy type 1. Participants will be randomized to receive one of three doses of ALKS 2680 (4 mg, 6 mg, or 8 mg) or placebo to be taken once daily for six weeks. 

The primary endpoint will assess whether participants taking ALKS 2680 experience a greater decrease in sleepiness compared to participants taking placebo alone, as measured by the change in mean sleep latency on the maintenance of wakefulness test. Secondary endpoints include change in Epworth Sleepiness Scale score, mean weekly cataplexy rate, and incidence of adverse events. 

“Initiation of the Vibrance-1 study is a significant milestone for the ALKS 2680 development program, and we look forward to further characterizing ALKS 2680’s safety and efficacy profile throughout this phase 2 study,” says Hopkinson in a release. 

The study is expected to enroll approximately 80 patients with narcolepsy type 1 across sites in the United States, Australia, and Europe. All participants in the double-blind portion of the study will be eligible to continue in the open-label safety extension portion of the study.

The company expects to initiate Vibrance-2, a planned phase 2 study in patients with narcolepsy type 2, in the second half of 2024.

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