Alkermes to Present Detailed Positive Results From Vibrance-1 Phase 2 Study Evaluating Alixorexton in Patients With Narcolepsy Type 1 at World Sleep 2025
Alkermes (Nasdaq: ALKS) will present detailed results from its Vibrance-1 Phase 2 study of alixorexton (formerly ALKS 2680) for narcolepsy type 1 (NT1) at the World Sleep Congress 2025 in Singapore. The study data will be shared through three oral presentations focusing on safety, efficacy, and patient-reported outcomes.
The presentations will detail improvements in fatigue, cognitive impairment, and other symptoms in NT1 patients. Alixorexton is a novel, oral, selective orexin 2 receptor (OX2R) agonist being developed as a once-daily treatment for NT1, narcolepsy type 2, and idiopathic hypersomnia. The company will host an investor webcast on September 8, 2025, at 8:00 a.m. ET to discuss the findings.
Alkermes (Nasdaq: ALKS) presenterà i risultati dettagliati del suo studio Vibrance-1 di Fase 2 sull'alixorexant (precedentemente ALKS 2680) per la narcolessia di tipo 1 (NT1) al World Sleep Congress 2025 a Singapore. I dati dello studio saranno presentati in tre comunicazioni orali che si concentreranno su sicurezza, efficacia e outcome riferiti dai pazienti.
Le presentazioni illustreranno i miglioramenti nella fatica, nel deficit cognitivo e in altri sintomi nei pazienti con NT1. L'alixorexant è un nuovo agonista orale selettivo del recettore dell'orexina 2 (OX2R) in sviluppo come trattamento una volta al giorno per NT1, narcolessia di tipo 2 e ipersonnia idiopatica. La società terrà una webcast per gli investitori il 8 settembre 2025 alle 8:00 ET per discutere i risultati.
Alkermes (Nasdaq: ALKS) presentará los resultados detallados de su estudio Vibrance-1 de fase 2 sobre alixorexant (antes ALKS 2680) para la narcolepsia tipo 1 (NT1) en el World Sleep Congress 2025 en Singapur. Los datos del estudio se darán a conocer mediante tres presentaciones orales centradas en seguridad, eficacia y resultados informados por los pacientes.
Las presentaciones detallarán las mejoras en la fatiga, el deterioro cognitivo y otros síntomas en pacientes con NT1. El alixorexant es un nuevo agonista oral selectivo del receptor de orexina 2 (OX2R) que se desarrolla como tratamiento de una vez al día para NT1, narcolepsia tipo 2 e hipersomnia idiopática. La compañía ofrecerá una retransmisión para inversores el 8 de septiembre de 2025 a las 8:00 ET para comentar los hallazgos.
Alkermes (Nasdaq: ALKS)는 싱가포르에서 열리는 World Sleep Congress 2025에서 기면증 1형(NT1) 치료 후보물질 알릭소렉산트(이전명 ALKS 2680)의 Vibrance-1 2상 연구의 상세 결과를 발표합니다. 연구 데이터는 안전성, 효능 및 환자보고결과에 중점을 둔 세 편의 구두 발표를 통해 공개됩니다.
발표에서는 NT1 환자의 피로, 인지기능 저하 및 기타 증상 개선에 대해 자세히 설명합니다. 알릭소렉산트는 신규 경구용 선택적 오렉신 2 수용체(OX2R) 작용제로, NT1, 기면증 2형 및 특발성 과다수면증의 하루 1회 치료제로 개발되고 있습니다. 회사는 결과를 논의하기 위해 2025년 9월 8일 오전 8시(동부표준시)에 투자자 웹캐스트를 개최할 예정입니다.
Alkermes (Nasdaq: ALKS) présentera les résultats détaillés de son essai Vibrance‑1 de phase 2 d'alixorexant (anciennement ALKS 2680) pour la narcolepsie de type 1 (NT1) au World Sleep Congress 2025 à Singapour. Les données de l'étude seront communiquées au travers de trois présentations orales axées sur la sécurité, l'efficacité et les résultats rapportés par les patients.
Les présentations détailleront les améliorations de la fatigue, des troubles cognitifs et d'autres symptômes chez les patients NT1. L'alixorexant est un nouvel agoniste oral sélectif du récepteur de l'orexine‑2 (OX2R) développé comme traitement quotidien pour la NT1, la narcolepsie de type 2 et l'hypersomnie idiopathique. La société organisera un webinaire pour investisseurs le 8 septembre 2025 à 8h00 ET pour commenter ces résultats.
Alkermes (Nasdaq: ALKS) wird die detaillierten Ergebnisse seiner Vibrance-1 Phase‑2‑Studie mit Alixorexant (früher ALKS 2680) bei Narkolepsie Typ 1 (NT1) auf dem World Sleep Congress 2025 in Singapur vorstellen. Die Studiendaten werden in drei mündlichen Präsentationen vorgestellt, die sich auf Sicherheit, Wirksamkeit und patientenberichtete Ergebnisse konzentrieren.
Die Präsentationen zeigen Verbesserungen bei Müdigkeit, kognitiven Beeinträchtigungen und weiteren Symptomen bei NT1-Patienten. Alixorexant ist ein neuartiger, oral verabreichter, selektiver Orexin‑2‑Rezeptor(OX2R)-Agonist, der als einmal täglich einzunehmende Behandlung für NT1, Narkolepsie Typ 2 und idiopathische Hypersomnie entwickelt wird. Das Unternehmen wird am 8. September 2025 um 8:00 Uhr ET ein Investoren‑Webcast abhalten, um die Ergebnisse zu besprechen.
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Insights
Alkermes' alixorexton shows positive Phase 2 results for narcolepsy, advancing their orexin receptor agonist pipeline with encouraging efficacy data.
Alkermes' upcoming presentation of detailed Vibrance-1 Phase 2 study results marks a significant milestone in their development of alixorexton (formerly ALKS 2680), a selective orexin 2 receptor (OX2R) agonist for narcolepsy type 1 (NT1). The data will feature three key presentations at World Sleep 2025, focusing on efficacy, safety, and patient-reported outcomes including improvements in disease severity, fatigue, and cognitive functioning.
The mechanism of action is particularly noteworthy. Orexin neuropeptides are the master regulators of wakefulness, produced in the lateral hypothalamus and activating multiple wake-promoting neural pathways. NT1 is characterized by orexin neuron loss, making this targeted approach scientifically sound. The once-daily oral administration represents a potentially convenient treatment option compared to existing therapies.
The comprehensive endpoint assessment is impressive, including both objective measures like the maintenance of wakefulness test (MWT) and weekly cataplexy rate (WCR), alongside subjective measures like the Epworth Sleepiness Scale (ESS). The inclusion of cognitive functioning outcomes is particularly valuable, as cognitive impairment significantly impacts patients' quality of life but is often overlooked in clinical trials.
The company is also broadening their investigation beyond NT1 to include narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH) in their Vibrance-2 and Vibrance-3 studies, respectively. This expanded scope could substantially increase the potential patient population and market opportunity if successful. The comprehensive development program demonstrates a systematic approach to addressing central disorders of hypersomnolence, which remain underserved therapeutic areas with significant unmet needs.
Alkermes' positive Phase 2 narcolepsy data represents significant pipeline progress, potentially expanding their neuroscience portfolio beyond current marketed products.
Alkermes' announcement represents meaningful progress for their neuroscience pipeline and growth strategy. The company is strategically positioning alixorexton as part of a broader clinical program targeting three related sleep disorders (NT1, NT2, and idiopathic hypersomnia), maximizing the potential return on their R&D investment. This systematic approach to exploring multiple indications in parallel could accelerate time-to-market across conditions.
The company's description as a "mid-cap growth and value equity global biopharmaceutical company" aligns with this development, as successful novel therapies could drive significant revenue growth beyond their existing commercial portfolio in alcohol/opioid dependence and psychiatric conditions. The orexin receptor agonist class is generating substantial interest in the neuropsychiatry space, suggesting strong market potential.
The positive Phase 2 data positions Alkermes competitively in the emerging orexin agonist landscape. While the press release doesn't disclose specific efficacy numbers, the planned presentations on efficacy, safety, and patient-reported outcomes indicate comprehensive data collection that could differentiate their candidate. The reference to "differentiating features" suggests the company believes their product may offer advantages over competitors.
From a pipeline perspective, this represents a significant milestone toward potential commercialization. Following the successful Phase 2 results, the next key inflection point would be advancement to Phase 3, which would require substantial investment but bring the asset closer to potential approval. The once-daily oral administration mentioned would likely enhance commercial prospects if efficacy and safety are confirmed in larger studies, as convenient dosing is particularly valuable in chronic conditions like narcolepsy.
– Results From Vibrance-1 to Be Shared in Three Oral Presentations, Including Primary and Secondary Efficacy and Safety Measures, and Exploratory Patient-Reported Outcomes Related to Disease Severity, Fatigue and Cognition –
– Company to Host Investor Webcast on Monday, Sept. 8 at 8:00 a.m. ET –
"We are honored to welcome leading researchers and clinicians from the global sleep medicine community to World Sleep Singapore 2025 Congress, where groundbreaking research in narcolepsy will be presented," said Raffaele Ferri, M.D., President of World Sleep Society. "We are looking forward to the presentation of new datasets on orexin 2 receptor agonists in development, as well as other innovative updates across the field of sleep medicine. I am encouraged by the continued interest and commitment from the global research community to improve the standard of care for people living with central disorders of hypersomnolence."
Following the recent announcement of positive topline results from Vibrance-1, the company plans to present additional details from this phase 2 study in three oral presentations. In addition, the company will present a poster outlining the study design and methods for Vibrance-3, a phase 2 clinical study evaluating the safety and efficacy of alixorexton compared to placebo in patients with IH.
"Substantial new datasets from the leading orexin 2 receptor agonists in development will be presented at this year's World Sleep Congress, representing an important milestone in understanding the broad implications of orexin biology as we seek to transform the treatment of narcolepsy," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President, Research & Development at Alkermes. "We look forward to sharing detailed data from our Vibrance-1 phase 2 study with clinicians at World Sleep. Along with important new findings related to improvements in fatigue and cognitive impairment – disruptive symptoms that impact patients' day-to-day lives – the efficacy, tolerability and safety data from Vibrance-1 will be presented, providing an overview of the differentiating features of once-daily alixorexton across a range of doses in patients with narcolepsy type 1."
Oral presentations
The following presentations will take place during the Targeting the orexin pathway: Emerging pharmacotherapies for narcolepsy type 1 session taking place on Monday, Sept. 8, 2025 (3:15– 4:46 p.m. SGT; 3:15– 4:46 a.m. ET):
Vibrance-1: A Randomized Phase 2 Study Evaluating Safety and Efficacy of the Orexin 2 Receptor Agonist Alixorexton (ALKS 2680) in Patients with Narcolepsy Type 1
- Presenter: 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.
Improvement in the Severity of Narcolepsy Symptoms and Fatigue in Patients with Narcolepsy Type 1 Treated with the Orexin 2 Receptor Agonist Alixorexton (ALKS 2680)
- Presenter: Yves Dauvilliers, M.D., Ph.D., Director, Sleep-Wake Disorders Center, Department of Neurology, Gui de Chauliac Hospital, Montpellier,
France .
Improvement in Patient-reported Cognitive Functioning in Patients with Narcolepsy Type 1 Treated with the Orexin 2 Receptor Agonist Alixorexton (ALKS 2680)
- Presenter: 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.
Poster Presentation
A Phase 2, Randomized, Placebo-Controlled, Parallel-Group Study Evaluating the Safety and Efficacy of ALKS 2680 in Patients With Idiopathic Hypersomnia: Study Design and Methods for Vibrance-3
- Poster Board Number: 169
- Presenter: Marcus Yountz, M.D., Alkermes
- Presentation Date: The poster will be presented on Tuesday, Sept. 9, 2025 from 4:45 – 5:45 p.m. SGT as part of poster abstract group 3.
Conference Call and Webcast
Alkermes will host a webcast presentation and conference call with accompanying slides for analysts and investors on Monday, Sept. 8, 2025, at 8:00 a.m. ET (8:00 p.m. SGT) to discuss these data. The webcast player may be accessed on the Investors section of Alkermes' website at www.alkermes.com. To participate in the question-and-answer session, please also dial in to the conference call, which may be accessed by dialing +1 877-407-2988 for
About the Vibrance-1 Phase 2 Study (NCT06358950)
Vibrance-1 is a phase 2, randomized, double-blind, dose-range-finding, placebo-controlled study evaluating the safety and efficacy of alixorexton (formerly referred to as ALKS 2680) in adults with narcolepsy type 1 (NT1). Participants (n=92) were randomized to receive one of three doses of alixorexton (4 mg, 6 mg or 8 mg) or placebo to be taken once-daily for six weeks. The primary endpoint assessed whether participants taking alixorexton experienced an improvement in wakefulness compared to participants taking placebo, as measured by the change from baseline in mean sleep latency on the maintenance of wakefulness test (MWT) at week six. Secondary endpoints included change from baseline in Epworth Sleepiness Scale (ESS) score at week 6 and mean weekly cataplexy rate (WCR) at weeks five and six, and incidence of adverse events. The study also included a number of exploratory patient-reported outcome measures, which evaluated the effect of alixorexton on participants' disease severity, fatigue and cognition. All participants in the double-blind portion of the study were eligible to continue to a seven-week open-label safety extension portion of the study, followed by a long-term safety study.
About Alixorexton
Alixorexton (formerly referred to as ALKS 2680) is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for 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 is currently being evaluated in the phase 2 Vibrance-1, Vibrance-2 and Vibrance-3 studies in patients with NT1, NT2 and IH, respectively.
About Alkermes plc
Alkermes plc (Nasdaq: ALKS) is a mid-cap growth and value equity 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 and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders, including narcolepsy and idiopathic hypersomnia. Headquartered in
Note Regarding Forward-Looking Statements
Certain statements set forth in this press release constitute "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, as amended, including, but not limited to, statements concerning the potential therapeutic and commercial value of alixorexton (formerly referred to as ALKS 2680). The company cautions that forward-looking statements are inherently uncertain. Although the company believes that such statements are based on reasonable assumptions within the bounds of its knowledge of its business and operations, the forward-looking statements are neither promises nor guarantees and they are necessarily subject to a high degree of uncertainty and risk. Actual performance and results may differ materially from those expressed or implied in the forward-looking statements due to various risks and uncertainties. These risks and uncertainties include, among others: whether initial clinical results for alixorexton will be predictive of results of future stages of ongoing clinical studies, future clinical studies or real-world results; whether ongoing or future clinical studies for alixorexton will be initiated or completed on expected timelines or at all; whether alixorexton could be shown to be ineffective or unsafe; potential changes in the cost, scope and duration of the alixorexton development program; and those risks and uncertainties described under the heading "Risk Factors" in the company's Annual Report on Form 10-K for the year ended Dec. 31, 2024 and in subsequent filings made by the company with the U.S. Securities and Exchange Commission (SEC), which are available on the SEC's website at www.sec.gov. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, the company disclaims any intention or responsibility for updating or revising any forward-looking statements contained in this press release.
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
Alkermes Contacts:
For Investors: Sandy Coombs, +1 781 609 6377
For Media: Gretchen Murphy, +1 781 609 6419
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