Alkermes plc ( ALKS ) on Monday released topline results from the randomized double-blind treatment period of the Vibrance-1 phase 2 study evaluating alixorexton in patients with narcolepsy type 1 (NT1).

Narcolepsy is a chronic neurological disorder that disrupts the body’s ability to regulate sleep-wake cycles. It’s characterized by excessive daytime sleepiness and sudden, uncontrollable sleep attacks.

Alixorexton, formerly ALKS 2680, is an investigational, oral orexin 2 receptor (OX2R) agonist in phase 2 development as a once-daily treatment for NT1, narcolepsy type 2 (NT2), and idiopathic hypersomnia (IH).

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In Vibrance-1, alixorexton met the primary endpoint across all doses tested, demonstrating statistically significant, clinically meaningful, and dose-dependent improvements in wakefulness on the Maintenance of Wakefulness Test (MWT) from baseline compared to placebo.

In addition to achieving normative wakefulness across all dose groups on the MWT (mean sleep latency >20 minutes), once-daily alixorexton demonstrated robust and clinically meaningful improvements compared to placebo on patient-reported outcomes related to excessive daytime sleepiness and other key symptoms such as fatigue and cognition.

Alixorexton was generally well tolerated at all doses tested. These data support rapid initiation of a global phase 3 program of alixorexton in patients with NT1.

Key Secondary Endpoints

Epworth Sleepiness Scale (ESS): At all doses tested, alixorexton drove statistically significant and clinically meaningful improvements from baseline in excessive daytime sleepiness compared to placebo on the Epworth Sleepiness Scale at week six (p