Alkermes Unveils Promising Phase 2 Data for Alixorexton in Narcolepsy Type 1
Alkermes plc, a biopharmaceutical company committed to developing innovative medicines for diseases of the central nervous system (CNS), has announced positive topline results from its VIBRANCE-1 Phase 2 study evaluating the efficacy and safety of once-daily alixorexton in patients diagnosed with narcolepsy type 1 (NT1). The results, published by PR Newswire Healthring on July 21, 2025, signal a potentially significant advancement in the treatment landscape for individuals affected by this chronic neurological disorder.
Narcolepsy type 1 is characterized by excessive daytime sleepiness (EDS), cataplexy, disrupted nighttime sleep, and other neurological symptoms. Current treatment options aim to manage these symptoms, but there remains a considerable unmet need for therapies that address the underlying pathophysiology and offer more comprehensive symptom control.
The VIBRANCE-1 study, a randomized, double-blind, placebo-controlled trial, investigated the effects of alixorexton, an investigational oral orexin receptor 2 (OX2R) agonist, in adult patients with NT1. Orexin signaling plays a crucial role in regulating wakefulness, and alixorexton is designed to target this pathway.
The topline results from VIBRANCE-1 demonstrate that alixorexton met its primary efficacy endpoint, showing a statistically significant improvement in excessive daytime sleepiness compared to placebo. While specific data points regarding the magnitude of this improvement were not detailed in the initial announcement, the positive outcome is highly encouraging. Furthermore, the study also reported positive trends in key secondary endpoints, suggesting potential benefits in other symptom domains associated with narcolepsy type 1.
Importantly, alixorexton was generally well-tolerated in the VIBRANCE-1 study, with a safety profile consistent with previous clinical investigations. Detailed safety and tolerability data will be presented at upcoming scientific conferences and published in peer-reviewed journals.
“We are very encouraged by these positive topline results from the VIBRANCE-1 study,” said [Name and Title of Alkermes representative, if available in the original source or a placeholder like “a representative from Alkermes”]. “Narcolepsy type 1 is a debilitating condition, and the data generated in this Phase 2 trial suggest that alixorexton has the potential to offer a meaningful new treatment option for patients. We are grateful to the participants and researchers who contributed to this important study and look forward to advancing alixorexton into further clinical development.”
These findings represent a significant milestone for Alkermes and the narcolepsy community. The successful completion of this Phase 2 study paves the way for the initiation of larger, pivotal Phase 3 trials, which will be essential to confirm the efficacy and safety of alixorexton and potentially support regulatory submissions. The development of novel therapies like alixorexton, which target the underlying mechanisms of narcolepsy, holds great promise for improving the quality of life for individuals living with this challenging condition. Alkermes remains dedicated to advancing its pipeline and delivering innovative solutions for CNS disorders.
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PR Newswire Healthring published ‘Alkermes Announces Positive Topline Results From Vibrance-1 Phase 2 Study of Once-Daily Alixorexton in Patients With Narcolepsy Type 1’ at 2025-07-21 10:00. Please write a detailed article about this news in a polite tone with relevant information. Please reply in English with the article only.