Alixorexton Shows Promise in Narcolepsy Treatment, Impacts Fatigue and Cognition
Recent trial results for the drug alixorexton demonstrate meaningful improvements for patients with narcolepsy, extending beyond traditional measures of sleepiness and cataplexy.Dr. Yountz, discussing the Vibrance-1 trial, highlighted the drugS positive impact on key symptoms and quality of life factors.
The trial assessed alixorexton across multiple doses and compared it to a placebo. Results showed meaningful improvements in core narcolepsy symptoms, including Maintenance of Wakefulness Test (MWT) scores, Epworth Sleepiness Scale results, and the frequency of cataplexy attacks. Importantly,the drug was well-tolerated,with no unexpected safety signals or trial discontinuations due to adverse events.
Beyond these primary endpoints, exploratory measures revealed notable benefits in areas frequently reported by patients but often overlooked in clinical trials: fatigue and cognitive function. Fatigue, described as a pervasive exhaustion distinct from sleepiness, affects over half of individuals with narcolepsy. The Vibrance-1 trial utilized the PROMIS Fatigue scale and patient Global Impression of fatigue severity, both demonstrating statistically significant and clinically meaningful improvements across all dose groups.
Similarly, patients often experience cognitive difficulties, often described as “brain fog,” including issues with focus, memory, and word retrieval. Using the British Columbia Cognitive Complaints Inventory (BC-CCI) and direct patient reporting, researchers observed statistically significant and clinically meaningful improvements in cognitive function. The consistency between patient-reported experiences and the structured inventory findings strengthens these results.
These findings suggest alixorexton may address the broader disease burden of narcolepsy, impacting not only the ability to stay awake but also daily functioning, including energy levels, concentration, and overall engagement in life.
Planning is underway for a phase 3 progress programme,informed by the data from Vibrance-1 and a previous phase 1b study. This program will investigate optimal doses and sensitive endpoints, and will focus on narcolepsy type 1 (NT1), narcolepsy type 2 (NT2), and idiopathic hypersomnia. Further details will be shared as plans are finalized, but the company is proceeding with “real momentum” towards potential regulatory approval.
