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Alkermes Reports Promising Results from Phase 2 Study of Alixorexton in Narcolepsy Type 1

Alkermes plc, a leader in biopharmaceuticals focusing on central nervous system disorders, recently shared positive topline outcomes from its Vibrance-1 Phase 2 study that evaluates Alixorexton’s effectiveness in managing Narcolepsy Type 1 (NT1). This study's results mark a significant milestone for both the company and patients dealing with debilitating symptoms of narcolepsy.

Study Overview

The Vibrance-1 study was a randomized, double-blind clinical trial involving 92 participants diagnosed with NT1. Patients were assigned to receive either Alixorexton or a placebo over a six-week period. Alixorexton, a novel oral orexin 2 receptor (OX2R) agonist previously known as ALKS 2680, showed statistically significant improvements in wakefulness levels as assessed by the Maintenance of Wakefulness Test (MWT). All doses tested yielded clinically meaningful enhancements in patient wakefulness compared to those on placebo.

Key Findings

Notable findings from the trial demonstrated:

• - Improved Wakefulness: Across all doses administered (4 mg, 6 mg, and 8 mg), participants taking Alixorexton exhibited notably improved mean sleep latency on the MWT, surpassing the normative levels established (>20 minutes). This was reported as statistically significant with p-values less than 0.0001 for each dosage.
• - Patient-Reported Outcomes: Patients also reported robust enhancements in symptoms related to fatigue, cognition, and overall narcolepsy severity when compared to placebo, further validating the efficacy of Alixorexton in real-world scenarios.
• - Tolerability: The medication was generally well tolerated among participants, with most adverse events being mild to moderate in severity. Importantly, no serious adverse events related to treatment were observed during the study duration.

Dr. Giuseppe Plazzi, an esteemed neurologist and director at the Narcolepsy Center in Bologna, emphasized the critical need for innovative treatments in NT1. He stated, "These compelling results demonstrated that once-daily Alixorexton normalized wakefulness in highly symptomatic patients. The breadth of benefit seen in our early patient-reported outcomes highlights the multifaceted impact this treatment could deliver."

Future Directions

Following the favorable outcomes from the Vibrance-1 study, Alkermes is rapidly moving towards initiating a global Phase 3 program for Alixorexton targeted explicitly at NT1 patients. This advancement comes in response to the identified gap in effective treatments currently available for those affected by this condition.

Craig Hopkinson, Chief Medical Officer at Alkermes, echoed the excitement surrounding these results, stating, "The data from Vibrance-1 underscores the transformative potential of orexin 2 receptor agonists for managing narcolepsy symptoms and reinforces our commitment to advancing Alixorexton further."

The detailed study results will be presented at the World Sleep Congress scheduled for September 2025 in Singapore, where the scientific community will eagerly anticipate insights into the clinical profile and therapeutic potential of Alixorexton.

Conclusion

As developed by Alkermes, Alixorexton represents a significant step forward in the fight against narcolepsy. Its ability to enhance wakefulness and manage fatigue and cognition in patients paves the way for a brighter future for those living with this challenging condition. The journey towards regulatory approval and patient accessibility is just beginning, promising hope for improved everyday living for individuals with NT1.