Alkermes Plc (NASDAQ: ALKS) has announced positive topline results from the vibrance-2 phase 2 study evaluating alixorexton in patients with narcolepsy type 2 (NT2). The study demonstrated statistically significant and clinically meaningful improvements in wakefulness and excessive daytime sleepiness compared to placebo in patients with NT2.
In the vibrance-2 study, patients with NT2 (n=93) were randomized to receive a once-daily dose of alixorexton (10 mg, 14 mg, or 18 mg) or placebo for eight weeks. The study met its dual primary endpoints, showing clinically meaningful improvements from baseline compared to placebo on the maintenance of wakefulness test (MWT) and Epworth Sleepiness Scale (ESS) at week eight.
Alixorexton was generally well tolerated at all doses tested, with most treatment-emergent adverse events (TEAEs) being mild to moderate in severity. No serious TEAEs were reported, and there were no safety signals observed in hepatic and renal parameters, vital signs, or ECGs. The most common TEAEs included pollakiuria, insomnia, urinary urgency, dizziness, and headache.
Emmanuel Mignot, M.D., Ph.D., Craig Reynolds Professor of Sleep Medicine at Stanford University, commented that the alixorexton data from vibrance-2 are the first demonstration in a large, randomized phase 2 study that an orexin 2 receptor agonist can drive clinically meaningful improvements in wakefulness and excessive daytime sleepiness in patients without known orexin deficiency, with a generally well-tolerated profile.
Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes, noted that the positive topline results from vibrance-2 mark a significant milestone for the narcolepsy patient community and for the alixorexton development program. He emphasized that alixorexton is the first and only oral orexin 2 receptor agonist to demonstrate efficacy in large randomized, double-blind, multi-week phase 2 studies across a range of once-daily doses in patients with narcolepsy type 1 and type 2.
Alkermes plans to present detailed results from the vibrance-2 phase 2 study, including exploratory patient-reported outcomes related to cognition and fatigue, at a future scientific meeting. The company also plans to initiate the alixorexton narcolepsy global phase 3 program in the first quarter of 2026.
Vibrance-3, a phase 2 study evaluating the safety and efficacy of alixorexton in adults with idiopathic hypersomnia (IH), is currently enrolling participants. Alkermes will host a webcast presentation and conference call with accompanying slides for analysts and investors to share additional data from the vibrance-2 study on Wednesday, Nov. 12, 2025, at 8:30 a.m. ET.
Alkermes Plc, a global biopharmaceutical company, seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders, including narcolepsy and idiopathic hypersomnia. Following these announcements, the company's shares moved 3.55%, and are now trading at a price of $33.81. If you want to know more, read the company's complete 8-K report here.
