Alkermes Reports Positive Results From Vibrance-1 Study of Alixorexton for Narcolepsy Type 1

Alkermes plc has unveiled promising results from the Vibrance-1 phase 2 clinical trial focused on evaluating alixorexton, a novel oral medication for individuals with narcolepsy type 1 (NT1). The trial's outcomes revealed significant enhancements in patient wakefulness across all doses of alixorexton compared to a placebo. Alixorexton, previously known as ALKS 2680, functions as an orexin 2 receptor (OX2R) agonist. This mechanism is designed to address various sleep disorders by activating wake-promoting pathways in the brain.

The Vibrance-1 study was a comprehensive, global, randomized, and double-blind placebo-controlled trial. It involved 92 adult participants diagnosed with NT1. These participants were assigned one of three daily doses of alixorexton (4 mg, 6 mg, or 8 mg) or a placebo over a six-week period. The primary endpoint of the study was to measure improvements in wakefulness through the Maintenance of Wakefulness Test (MWT). Results indicated that all dose groups achieved significant improvement in wakefulness, maintaining a mean sleep latency of over 20 minutes, which was a marked enhancement over the placebo group.

Key secondary outcomes also demonstrated notable progress. Alixorexton significantly improved scores on the Epworth Sleepiness Scale (ESS), a measure of excessive daytime sleepiness, compared to the placebo group. Furthermore, there were numerical improvements in weekly cataplexy rates across all doses of alixorexton, with the 6 mg dose achieving statistical significance.

Patient-reported outcomes further highlighted the benefits of alixorexton. The Narcolepsy Severity Scale (NSS) showed significant improvements in symptom severity, while the British Columbia Cognitive Complaints Inventory (BC-CCI) reported significant reductions in cognitive complaints. Additionally, the PROMIS-Fatigue measure indicated substantial decreases in fatigue symptoms.

Alixorexton was generally well tolerated, with no serious adverse events reported. The majority of adverse events were mild to moderate, aligning with observations from previous studies involving healthy volunteers and patients with NT1, NT2, and idiopathic hypersomnia (IH).

Dr. Giuseppe Plazzi, an expert in neurology and narcolepsy, noted the transformative potential of alixorexton in managing NT1 symptoms. He emphasized the drug's ability to normalize wakefulness and address patient-reported issues related to fatigue and cognition. These findings suggest that alixorexton could offer a comprehensive treatment option for NT1 patients, who often experience persistent and disruptive symptoms.

Craig Hopkinson, Chief Medical Officer and Executive Vice President of Research & Development at Alkermes, expressed enthusiasm about the study's positive results. He highlighted the company's commitment to swiftly advancing alixorexton into a global phase 3 program. Detailed findings from Vibrance-1 are scheduled to be presented at the World Sleep Congress, further exploring alixorexton's potential in treating narcolepsy.

The development of alixorexton underscores Alkermes' pioneering efforts in the field of neuroscience. The company is dedicated to expanding its portfolio of orexin 2 receptor agonists, aiming to address not just wakefulness but also other symptoms like fatigue and cognitive challenges associated with narcolepsy.

The Vibrance-1 trial marks a significant step forward in understanding the therapeutic potential of alixorexton. As Alkermes pushes towards phase 3 development, the pharmaceutical landscape for narcolepsy treatments continues to evolve, offering hope for more effective management of this challenging condition.