Alkermes(US:ALKS) Prnewswireยท2024-04-24 11:00Core Insights - Alkermes plc has initiated the Vibrance-1 study, a phase 2 clinical trial for ALKS 2680, an investigational oral orexin 2 receptor agonist aimed at treating narcolepsy type 1 (NT1) [1][2] - The study will evaluate the safety and efficacy of ALKS 2680 compared to placebo, with a primary endpoint focused on sleepiness reduction as measured by the maintenance of wakefulness test (MWT) [2][4] - Approximately 80 patients with NT1 will be enrolled across sites in the U.S., Australia, and Europe, with the study expected to last six weeks [2][3] Study Design - Vibrance-1 is a randomized, double-blind, dose-range-finding, placebo-controlled study [2] - Participants will receive one of three doses of ALKS 2680 (4 mg, 6 mg, or 8 mg) or placebo, taken once daily [2] - Secondary endpoints include changes in the Epworth Sleepiness Scale (ESS) score, mean weekly cataplexy rate (WCR), and incidence of adverse events [2] Future Developments - Alkermes plans to initiate Vibrance-2, a phase 2 study for narcolepsy type 2, in the second half of 2024 [3] Company Overview - Alkermes plc is a global biopharmaceutical company focused on developing innovative medicines in neuroscience, with a portfolio addressing various neurological disorders [5] - The company is headquartered in Dublin, Ireland, and has research and manufacturing facilities in the U.S. and Ireland [5]