Alkermes plc said its investigational narcolepsy therapy alixorexton met key efficacy endpoints in a mid-stage trial, positioning the drug for late-stage development.
In the six-week Vibrance-1 Phase 2 study of 92 adults with narcolepsy type 1, once-daily 4 mg, 6 mg and 8 mg doses of alixorexton produced statistically significant improvements in excessive daytime sleepiness versus placebo, the company reported. All dose groups achieved mean sleep latency of at least 20 minutes on the Maintenance of Wakefulness Test and Epworth Sleepiness Scale scores of 10 or below at week six, levels considered within the normative range.
The 6 mg cohort also showed a reduction in weekly cataplexy rate compared with placebo. Trial data were published in The Lancet Neurology. No serious adverse events were reported, and most treatment-emergent side effects were mild to moderate in severity.
Alixorexton, a selective orexin 2 receptor agonist dosed orally once daily, has previously received U.S. FDA Breakthrough Therapy designation for narcolepsy type 1 and Orphan Drug Designation for idiopathic hypersomnia. Alkermes initiated the global Brilliance Phase 3 program to evaluate once-daily and split-dose regimens in adults with narcolepsy type 1 and type 2.
Alkermes, headquartered in Ireland with operations in Massachusetts and Ohio, markets products for alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy.
