Alkermes’ Alixorexton Demonstrated Sustained Improvement in Wakefulness in Adults With Narcolepsy Type 1 and Type 2 in Long-Term Extension Study Interim Analysis
— First Long-Term Study of an Orexin 2 Receptor Agonist to Demonstrate Sustained Clinically Meaningful Improvements in Wakefulness and Excessive Daytime Sleepiness for Up to Nine Months in Narcolepsy Type 1 and Type 2 —
— Improvements in Patient-Reported Cognition and Fatigue Were Also Sustained —
— Alixorexton Was Generally Well Tolerated at All Doses Tested —
Alkermes plc (Nasdaq: ALKS) today announced results from a planned interim analysis of the ongoing long-term extension (LTE) study evaluating alixorexton in adults with narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2). Across all dose groups in both NT1 and NT2 participants, alixorexton demonstrated sustained clinically meaningful improvement from baseline1 on the Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS) at week 24 of the LTE, approximately nine months after the first dose for participants treated with alixorexton in the randomized double-blind period of the Vibrance-1 and Vibrance-2 phase 2 studies. Alixorexton also demonstrated sustained and clinically meaningful improvement from baseline across patient-reported outcomes (PROs) evaluating cognition and fatigue at week 24. Alixorexton was generally safe and well tolerated at all doses tested. Alixorexton is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development for the treatment of NT1, NT2 and idiopathic hypersomnia (IH).
