Biopharmaceutical company Alkermes plc (Nasdaq: ALKS) on Wednesday announced positive topline results from its Phase 2 Vibrance-2 study evaluating alixorexton, a once-daily, oral orexin 2 receptor agonist, in patients with narcolepsy type 2 (NT2).
Alixorexton met both primary endpoints, showing statistically significant and clinically meaningful improvements in wakefulness and excessive daytime sleepiness compared with placebo at week eight, as measured by the Maintenance of Wakefulness Test and Epworth Sleepiness Scale. The treatment was generally well tolerated at all tested doses, with most adverse events reported as mild to moderate.
Ninety-three patients were enrolled and randomised to receive 10 mg, 14 mg or 18 mg doses of alixorexton, or placebo, for eight weeks. Approximately 95% of participants completed the double-blind phase and continued into an ongoing open-label extension.
Results from Vibrance-2, together with findings from the Vibrance-1 study in narcolepsy type 1 (NT1), support the planned launch of a global Phase 3 programme for NT1 and NT2 in the first quarter of 2026. Alkermes also continues enrolment in Vibrance-3, a Phase 2 trial investigating alixorexton in idiopathic hypersomnia.
Detailed data from Vibrance-2, including exploratory outcomes on cognition and fatigue, will be presented at an upcoming scientific meeting.
enGene reports 62% six-month complete response rate for detalimogene in LEGEND trial
Lytix Biopharma reports strong interim results from Phase 2 melanoma study with ruxotemitide
Nurami Medical completes Phase 1 milestones in EIC-backed grant for Artifix
Insilico Medicine forms research collaboration with Eli Lilly
Neurocrine Biosciences reports NBI-1070770 did not meet primary endpoint in Phase 2 study
Calliditas Therapeutics reports initial data for Phase 2a setanaxib trial in Alport syndrome
Innate Pharma cleared by FDA to launch TELLOMAK 3 Phase 3 trial of lacutamab in CTCL