DUBLIN, Ireland — Alkermes plc (Nasdaq: ALKS) today announced the initiation of the Brilliance Studies, a phase 3 program evaluating the safety and efficacy of alixorexton compared to placebo in adults with narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2). Alixorexton is the company’s novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development for the treatment of NT1, NT2 and idiopathic hypersomnia (IH).
The Brilliance Studies program consists of three 12-week, randomized, double-blind, placebo-controlled phase 3 studies evaluating once-daily and split-dose regimens of alixorexton: Brilliance NT1 (Study 302 and Study 304) and Brilliance NT2 (Study 303).
- Brilliance NT1 Studies (Study 302 and Study 304): Participants in each Brilliance NT1 study will be randomized to receive one of two dosing regimens of alixorexton or placebo to be taken daily for 12 weeks. The primary endpoint of each study will assess whether participants taking alixorexton experience an increase in wakefulness compared to participants taking placebo, as measured by the change in mean sleep latency on the maintenance of wakefulness test (MWT). Secondary endpoints include change in Epworth Sleepiness Scale (ESS) score, mean weekly cataplexy rate (WCR), patient-reported outcomes related to fatigue, cognition and disease severity, and incidence of adverse events. Each study is expected to enroll approximately 150 patients with NT1 across sites in North America, Asia Pacific and Europe.
- Brilliance NT2 Study (Study 303): Participants in the Brilliance NT2 study will be randomized to receive one of three dosing regimens of alixorexton or placebo to be taken daily for 12 weeks. The primary endpoint will assess whether participants taking alixorexton experience an increase in wakefulness compared to participants taking placebo alone, as measured by the change in mean sleep latency on the MWT. Secondary endpoints include change in ESS score, patient-reported outcomes related to fatigue, cognition and disease severity, and incidence of adverse events. The Brilliance NT2 study is expected to enroll approximately 180 patients with NT2 across sites in North America, Asia Pacific and Europe.
“The initiation of the phase 3 Brilliance Studies program marks an exciting and important milestone for alixorexton. Building on the positive findings observed in our large phase 2 program across both narcolepsy type 1 and type 2, we are entering this pivotal stage with confidence. We look forward to evaluating alixorexton in both once-daily and split-dose regimens as we seek to optimize efficacy, safety and dosing flexibility in the development of a potential new treatment option for patients and providers,” said Craig Hopkinson, M.D. (MBChB), Chief Medical Officer and Executive Vice President of Research & Development at Alkermes.
Participants who complete one of the Brilliance Studies will be eligible to continue in a long-term, open-label, safety study. More information can be found at www.brilliancestudies.com (for U.S. audiences only) and www.clinicaltrials.gov (Brilliance NT1 – Study 302: NCT07455383; Brilliance NT2: NCT07502443; Brilliance NT1 – Study 304: Coming soon).
About Alixorexton
Alixorexton (formerly referred to as ALKS 2680) is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development for the treatment of narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH). Orexin, a neuropeptide produced in the lateral hypothalamus, is considered to be the master regulator of wakefulness due to its activation of multiple, downstream wake-promoting pathways that project widely throughout the brain.1 Targeting the orexin system may address excessive daytime sleepiness across hypersomnolence disorders, whether or not deficient orexin signaling is the underlying cause of disease.2 Once-daily oral administration of alixorexton was previously evaluated in a phase 1 study in healthy volunteers and patients with NT1, NT2 and IH, and in Vibrance-1 and Vibrance-2, phase 2 studies in patients with NT1 and NT2, respectively. It is currently being evaluated in the phase 3 Brilliance Studies in patients with NT1 and NT2, and in the phase 2 Vibrance-3 study in patients with IH. Alixorexton has received Breakthrough Therapy designation for the treatment of NT1 from the U.S. Food and Drug Administration (FDA).
About Alkermes plc
Alkermes plc (Nasdaq: ALKS), a mid-cap growth and value equity, is a global biopharmaceutical company that seeks to develop innovative medicines in the field of neuroscience. The company has a portfolio of proprietary commercial products for the treatment of alcohol dependence, opioid dependence, schizophrenia, bipolar I disorder and narcolepsy. Alkermes’ pipeline includes late-stage clinical candidates in development for narcolepsy and idiopathic hypersomnia, and orexin 2 receptor agonists in early clinical development for other neurological disorders, including attention-deficit hyperactivity disorder (ADHD) and fatigue associated with multiple sclerosis and Parkinson’s disease. Headquartered in Ireland, Alkermes also has a corporate office and research and development center in Massachusetts and a manufacturing facility in Ohio. For more information, please visit Alkermes’ website at www.alkermes.com.
References
1 Buysse, D. Diagnosis and assessment of sleep and circadian rhythm disorders. Journal of Psychiatric Practice. 2005; 11(2):102-115
2 Ten-Blanco M, Flores A, Cristino L, Pereda-Perez I. Targeting the orexin/hypocretin system for the treatment of neuropsychiatric and neurodegenerative diseases: From animal to clinical studies. Frontiers in Neuroendocrinology. 2023;69(101066). https://www.sciencedirect.com/science/article/pii/S0091302223000146
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