Alkermes plc announced the publication of data from the Vibrance‑1 phase 2 study of alixorexton in adults with narcolepsy type 1 (NT1) in The Lancet Neurology. Alixorexton is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development for the treatment of NT1, narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH). Based on the positive results demonstrated by alixorexton in the phase 2 Vibrance Studies in NT1 and NT2, Alkermes has initiated the Brilliance Studies, a global phase 3 program evaluating once-daily and split dose regimens of alixorexton in adults with NT1 and NT2.
The phase 2 Vibrance-1 study was conducted in 92 adults with NT1 and included a six-week, randomized, placebo-controlled, double-blind period followed by an optional seven-week open-label extension. As previously announced, treatment with once-daily alixorexton led to statistically significant improvements from baseline versus placebo in both objective and subjective measures of excessive daytime sleepiness, as measured by the Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS)1, respectively. All dose groups (4 mg, 6 mg and 8 mg) achieved mean sleep latency values within the normative range on the MWT (i.e., ≥20 minutes) and ESS (a score of ≤10) at week six. Weekly cataplexy rate2 was significantly decreased versus placebo in the 6 mg alixorexton group. Alixorexton also demonstrated clinically meaningful improvements on exploratory patient-reported endpoints assessing overall disease severity, fatigue, cognition and health-related quality of life. Alixorexton treatment was generally well tolerated, with most treatment-emergent adverse events (TEAEs) being mild to moderate in severity, and no serious TEAEs.
“The data published in The Lancet Neurology highlight the robust efficacy of once-daily doses of alixorexton in patients with narcolepsy type 1 across measures of wakefulness and excessive daytime sleepiness. Along with a generally well-tolerated profile, alixorexton demonstrated improvements across a broad range of symptoms that affect daily functioning, including cataplexy, overall disease severity, cognition and fatigue. These data are a substantial contribution to the evidence base supporting the potential of orexin 2 receptor agonists to transform the treatment of narcolepsy and the utility of a range of doses to address the individual needs of people living with NT1,” said Giuseppe Plazzi, M.D., Ph.D., Neurologist, Director of the Narcolepsy Center at the IRCCS of the Neurological Sciences of Bologna and Professor of Childhood Neuropsychiatry at the University of Modena and Reggio Emilia.
“In the Vibrance-1 study, alixorexton demonstrated substantial and clinically meaningful benefits across multiple dimensions of narcolepsy type 1,” said Craig Hopkinson, M.D. (MBChB), Chief Medical Officer and Executive Vice President, Research & Development at Alkermes. “The totality of evidence generated across the Vibrance phase 2 program in narcolepsy has reinforced our confidence in alixorexton’s potential to meaningfully impact the lives of people living with narcolepsy type 1 and type 2. These findings highlight the potential of alixorexton to address a broad range of symptoms that continue to burden patients despite currently available therapies. With the global Brilliance phase 3 program now underway in both narcolepsy type 1 and type 2, we are excited to continue advancing alixorexton in this next stage of development.”
Source: Businesswire
