Alkermes is set to present detailed positive results from its Vibrance-1 Phase 2 study of alixorexton, a novel, once-daily oral orexin 2 receptor agonist, in patients with narcolepsy type 1 (NT1) at the World Sleep Congress 2025 in Singapore. These findings, to be shared in three oral presentations, will highlight the drug’s efficacy, safety, and impact on fatigue and cognition, critical symptoms for those living with NT1.
About Alixorexton and the Vibrance-1 Study
According to Yahoo!Finance, Alixorexton (formerly ALKS 2680) is designed to selectively activate orexin 2 receptors (OX2R), directly targeting the brain’s key regulator of wakefulness. This approach aims to restore normal sleep-wake balance in narcolepsy, where orexin signaling is deficient. Vibrance-1 is a randomized, double-blind, placebo-controlled Phase 2 trial involving 92 adults with NT1. Participants received one of three alixorexton doses (4 mg, 6 mg, or 8 mg) or placebo once daily for six weeks.
The primary measure was improvement in wakefulness, assessed by the Maintenance of Wakefulness Test (MWT). Secondary endpoints included changes in Epworth Sleepiness Scale (ESS) scores, weekly cataplexy rates, and safety outcomes. Exploratory outcomes evaluated self-reported disease severity, fatigue, and cognitive function.
Key Findings to Be Presented
Topline results show that alixorexton led to clinically meaningful improvements in wakefulness compared to placebo, as well as reductions in sleepiness and cataplexy episodes. Importantly, presentations will also detail improvements in patient-reported fatigue and cognitive functioning, addressing symptoms that profoundly affect daily life for people with narcolepsy.
The data will be presented by leading sleep medicine experts Dr. Giuseppe Plazzi and Dr. Yves Dauvilliers, who will discuss not only the primary and secondary endpoints, but also the broader impact of alixorexton on patient quality of life.
Broader Implications and Ongoing Research
Alkermes is also advancing alixorexton in Phase 2 studies for narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH), as part of its Vibrance clinical program. A poster outlining the design of the Vibrance-3 study in IH will be featured at the congress.
As a once-daily oral therapy, alixorexton could offer a differentiated treatment option for NT1, potentially addressing not only excessive daytime sleepiness and cataplexy but also the often-overlooked burdens of fatigue and cognitive impairment.
Looking Ahead
Alkermes will host an investor webcast to further discuss these findings. While the company cautions that continued research is needed to confirm these results and advance alixorexton through regulatory review, the Vibrance-1 data mark a significant step forward in narcolepsy care. If future studies validate these results, alixorexton could help transform the standard of care for people with NT1 and related disorders.
