Summary: Alkermes plc has initiated the Vibrance-2 study, a phase 2 clinical trial designed to evaluate the safety and efficacy of ALKS 2680, a novel oral orexin 2 receptor agonist, in treating narcolepsy type 2. The study will involve approximately 80 adults with narcolepsy type 2 across multiple global sites and will compare the effects of ALKS 2680 at different doses against a placebo, with a focus on reducing sleepiness. The trial’s primary endpoint will assess changes in sleep latency, with secondary endpoints including changes in the Epworth Sleepiness Scale score and the incidence of adverse events.
Key Takeaways:
- Initiation of Vibrance-2 Study: Alkermes has begun a phase 2 clinical trial to evaluate ALKS 2680, a once-daily oral treatment, for its effectiveness in reducing sleepiness in adults with narcolepsy type 2.
- Study Design: The randomized, double-blind, placebo-controlled trial will enroll approximately 80 patients and will assess the drug’s efficacy by measuring changes in sleep latency and sleepiness scores, with participants eligible for an open-label extension.
- Global Participation: The study will be conducted across sites in the US, Australia, and Europe.
Alkermes plc announced the initiation of the Vibrance-2 study, a phase 2 clinical trial evaluating the safety and efficacy of ALKS 2680 compared to placebo in adults with narcolepsy type 2.
ALKS 2680 is the company’s novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for narcolepsy.
“We are pleased to initiate Vibrance-2, a phase 2 clinical study for adults with narcolepsy type 2, based on the data from our phase 1, 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,” says Craig Hopkinson, MD, chief medical officer and executive vice president of research and development at Alkermes, in a release. “Across narcolepsy type 1 and narcolepsy type 2, significant unmet need remains, and we look forward to further characterizing the efficacy and safety profile of ALKS 2680 in the Vibrance studies in both of these important patient populations.”
Vibrance-2 Study
Vibrance-2 is a phase 2, randomized, double-blind, dose-range-finding, placebo-controlled study evaluating the safety and efficacy of ALKS 2680 in adults with narcolepsy type 2. Participants will be randomized to receive one of three doses of ALKS 2680 (10 mg, 14 mg, or 18 mg) or placebo to be taken once-daily for eight 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 and incidence of adverse events.
The study is expected to enroll approximately 80 patients with narcolepsy type 2 across sites in the US, Australia, and Europe. All participants who complete the double-blind portion of the study will be eligible to continue in the open-label safety extension.
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