Alkermes Announces Initiation of Vibrance-2 Phase 2 Study Evaluating ALKS 2680 for the Treatment of Narcolepsy Type 2
Alkermes plc (Nasdaq: ALKS) has initiated the Vibrance-2 study, a phase 2 clinical trial evaluating ALKS 2680 for the treatment of narcolepsy type 2 (NT2). ALKS 2680 is a novel, oral, selective orexin 2 receptor agonist being developed as a once-daily treatment for narcolepsy. The study will assess the safety and efficacy of ALKS 2680 compared to placebo in adults with NT2.
The trial will enroll approximately 80 patients across sites in the U.S., Australia, and Europe. Participants will receive one of three doses of ALKS 2680 (10 mg, 14 mg, or 18 mg) or placebo once-daily for eight weeks. The primary endpoint will measure changes in sleepiness using the maintenance of wakefulness test (MWT).
Alkermes plc (Nasdaq: ALKS) ha avviato lo studio Vibrance-2, uno studio clinico di fase 2 che valuta ALKS 2680 per il trattamento della narcolessia di tipo 2 (NT2). ALKS 2680 è un nuovo agonista selettivo del recettore orexina 2, sviluppato come trattamento orale da assumere una volta al giorno per la narcolessia. Lo studio valuterà la sicurezza e l'efficacia di ALKS 2680 rispetto al placebo in adulti con NT2.
Il trial recluterà circa 80 pazienti in diverse sedi negli Stati Uniti, in Australia e in Europa. I partecipanti riceveranno una delle tre dosi di ALKS 2680 (10 mg, 14 mg o 18 mg) o placebo una volta al giorno per otto settimane. L'endpoint principale misurerà i cambiamenti nella sonnolenza utilizzando il test di mantenimento della vigilanza (MWT).
Alkermes plc (Nasdaq: ALKS) ha iniciado el estudio Vibrance-2, un ensayo clínico de fase 2 que evalúa ALKS 2680 para el tratamiento de la narcolepsia tipo 2 (NT2). ALKS 2680 es un nuevo agonista selectivo del receptor de orexina 2, desarrollado como un tratamiento oral que se toma una vez al día para la narcolepsia. El estudio evaluará la seguridad y eficacia de ALKS 2680 en comparación con un placebo en adultos con NT2.
El ensayo inscribirá aproximadamente a 80 pacientes en sitios en EE.UU., Australia y Europa. Los participantes recibirán una de tres dosis de ALKS 2680 (10 mg, 14 mg o 18 mg) o placebo una vez al día durante ocho semanas. El objetivo principal medirá los cambios en la somnolencia mediante la prueba de mantenimiento de la vigilia (MWT).
Alkermes plc (Nasdaq: ALKS)는 Vibrance-2 연구를 시작했습니다. 이는 ALKS 2680의 2상 임상시험으로 2형 기면증(NT2) 치료를 평가하는 것입니다. ALKS 2680은 기면증에 대한 일일 복용을 위해 개발된 새로운 경구용 선택적 오렉신 2 수용체 작용제입니다. 이번 연구에서는 NT2를 가진 성인에서 ALKS 2680과 위약 간의 안전성과 효능을 평가할 것입니다.
이 시험에는 미국, 호주 및 유럽의 여러 사이트에서 약 80명의 환자가 등록될 예정입니다. 참가자는 10 mg, 14 mg 또는 18 mg의 ALKS 2680 중 하나 또는 위약을 하루 한 번 8주 동안 복용하게 됩니다. 주요 목표는 각성 유지 테스트(MWT)를 사용하여 졸림 변화량을 측정하는 것입니다.
Alkermes plc (Nasdaq: ALKS) a lancé l'étude Vibrance-2, un essai clinique de phase 2 évaluant ALKS 2680 pour le traitement de la narcolepsie de type 2 (NT2). ALKS 2680 est un nouvel agoniste oral sélectif des récepteurs orexines 2, développé comme un traitement quotidien unique pour la narcolepsie. L'étude évaluera la sécurité et l'efficacité d'ALKS 2680 par rapport à un placebo chez des adultes atteints de NT2.
L'essai recrutera environ 80 patients dans des centres aux États-Unis, en Australie et en Europe. Les participants recevront l'une des trois doses d'ALKS 2680 (10 mg, 14 mg ou 18 mg) ou un placebo une fois par jour pendant huit semaines. Le critère principal mesurera les changements de somnolence grâce au test de maintien de l'éveil (MWT).
Alkermes plc (Nasdaq: ALKS) hat die Vibrance-2 Studie initiiert, eine Phase-2-Studie, die ALKS 2680 zur Behandlung von Narcolepsie Typ 2 (NT2) bewertet. ALKS 2680 ist ein neuartiger, oral verabreichbarer, selektiver Agonist des Orexin-2-Rezeptors, der als einmal tägliche Behandlung für Narcolepsie entwickelt wird. Die Studie wird die Sicherheit und Wirksamkeit von ALKS 2680 im Vergleich zum Placebo bei Erwachsenen mit NT2 untersuchen.
Die Studie wird voraussichtlich etwa 80 Patienten an Standorten in den USA, Australien und Europa einschließen. Die Teilnehmer erhalten eine von drei Dosen von ALKS 2680 (10 mg, 14 mg oder 18 mg) oder Placebo einmal täglich über einen Zeitraum von acht Wochen. Der primäre Endpunkt wird die Veränderungen in der Schläfrigkeit mit dem Test zur Aufrechterhaltung der Wachsamkeit (MWT) messen.
- Initiation of phase 2 clinical trial for ALKS 2680 in narcolepsy type 2
- ALKS 2680 is the most advanced investigational orexin 2 receptor agonist for NT2
- Potential to address significant unmet need in narcolepsy treatment
- Results of the clinical trial are not yet known
- Potential for adverse events in study participants
Insights
The initiation of the Vibrance-2 Phase 2 study for ALKS 2680 in narcolepsy type 2 (NT2) patients is a significant milestone for Alkermes. This novel orexin 2 receptor agonist could potentially address a major unmet need in NT2 treatment. The study's design, including multiple dose levels and key endpoints like the Maintenance of Wakefulness Test, is robust and well-thought-out.
The 80-patient target across multiple countries suggests a comprehensive approach to data collection. If successful, ALKS 2680 could offer a targeted therapy for NT2, potentially improving upon current non-specific treatments. However, investors should note that Phase 2 results are still preliminary and success here doesn't guarantee Phase 3 efficacy or eventual FDA approval.
ALKS 2680's mechanism as an orexin 2 receptor agonist is particularly intriguing for NT2. Unlike narcolepsy type 1, where orexin-producing neurons are lost, NT2's underlying pathology is less clear. This targeted approach could potentially address the root cause of excessive daytime sleepiness in NT2 patients more effectively than current treatments.
The once-daily oral administration is a significant advantage, potentially improving patient compliance. However, the 8-week treatment duration may not fully capture long-term efficacy and safety. It's important to monitor for any tolerance development or unexpected side effects in extended use. The open-label extension will provide valuable long-term data, but results from this won't be available for some time.
Alkermes' advancement of ALKS 2680 into Phase 2 for both narcolepsy types positions them well in the competitive landscape of narcolepsy treatments. As the "most advanced investigational orexin 2 receptor agonist" for NT2, they could potentially capture a significant market share if successful.
The estimated 200,000 adult narcolepsy patients in the US represent a substantial market opportunity. However, investors should consider that market penetration may be challenging due to existing treatments and potential competition from other companies developing similar drugs. The financial impact will depend on pricing strategy, efficacy compared to existing treatments and the ability to obtain favorable reimbursement terms from insurers.
"We are pleased to initiate Vibrance-2, a phase 2 clinical study for adults with narcolepsy type 2, based on the data from our phase 1, proof-of-concept study in this patient population. ALKS 2680 is the most advanced investigational orexin 2 receptor agonist currently in development for narcolepsy type 2," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President, Research & Development at Alkermes. "Across narcolepsy type 1 and narcolepsy type 2, significant unmet need remains, and we look forward to further characterizing the efficacy and safety profile of ALKS 2680 in the Vibrance studies in both of these important patient populations."
Vibrance-2 is a phase 2, randomized, double-blind, dose-range-finding, placebo-controlled study evaluating the safety and efficacy of ALKS 2680 in adults with NT2. Participants will be randomized to receive one of three doses of ALKS 2680 (10 mg, 14 mg or 18 mg) or placebo to be taken once-daily for eight weeks. The primary endpoint will assess whether participants taking ALKS 2680 experience a greater decrease in sleepiness compared to participants taking placebo alone, 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 and incidence of adverse events. The study is expected to enroll approximately 80 patients with NT2 across sites in the
More information can be found at www.clinicaltrials.gov (identifier: NCT06555783) and www.vibrancestudies.com (for
Vibrance-1, a phase 2 study evaluating the efficacy and safety of ALKS 2680 in adults with narcolepsy type 1, is currently enrolling.
About ALKS 2680
ALKS 2680 is a novel, investigational, oral, selective orexin 2 receptor (OX2R) agonist in development as a once-daily treatment for narcolepsy. 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 ALKS 2680 was previously evaluated in a phase 1 study in healthy volunteers and patients with narcolepsy type 1 (NT1), narcolepsy type 2 (NT2) and idiopathic hypersomnia, and is currently being evaluated in the phase 2 Vibrance-1 and Vibrance-2 studies in patients with NT1 and NT2, respectively.
About Narcolepsy
Narcolepsy is a chronic, neurological disorder that affects the brain's ability to regulate the sleep/wake cycle. Excessive daytime sleepiness is the hallmark symptom of narcolepsy; additional symptoms can include sleep paralysis, sleep-related hallucinations and disturbed nighttime sleep.3 There are two types of narcolepsy: narcolepsy type 1 is characterized by the loss of orexin-producing neurons, and is also associated with cataplexy, a sudden loss of muscle control while a person is awake, often trigged by strong emotions.4 The underlying neuropathology of narcolepsy type 2 remains to be fully elucidated; however the orexin pathway may play an important role.5 Narcolepsy affects an estimated 200,000 adults in America, with men and women affected equally.6
About the Vibrance Studies
The Vibrance Studies are phase 2, randomized, double-blind, dose-range-finding studies evaluating the safety and efficacy of ALKS 2680 compared to placebo in patients with narcolepsy type 1 (Vibrance-1; NCT06358950) and narcolepsy type 2 (Vibrance-2; NCT06555783). More information can be found at www.vibrancestudies.com (for
About Alkermes plc
Alkermes plc 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 and bipolar I disorder, and a pipeline of clinical and preclinical candidates in development for neurological disorders, including narcolepsy. 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 value of ALKS 2680 for the treatment of narcolepsy; and the company's expectations regarding clinical development activities for 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 ALKS 2680 could be shown to be ineffective or unsafe; potential changes in the cost, scope and duration of the ALKS 2680 development program; whether preclinical and initial clinical results for ALKS 2680 will be predictive of results of future clinical studies or real-world results; whether future clinical trials or future stages of ongoing clinical trials for ALKS 2680 will be initiated or completed on time or at all; 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, 2023 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
3 Ruoff C, Rye D. The ICSD-3 and DSM-5 guidelines for diagnosing narcolepsy: clinical relevance and practicality. Curr Med Res Opin. 2016;32(10):1611-1622. doi:10.1080/03007995.2016.1208643
4 Dauvilliers Y, Siegel JM, Lopez R, Torontali ZA, Peever JH. Cataplexy--clinical aspects, pathophysiology and management strategy. Nat Rev Neurol. 2014;10(7):386-395. doi:10.1038/nrneurol.2014.97
5 Bassetti CLA, Adamantidis A, Burdakov D, et al. Narcolepsy - clinical spectrum, aetiopathophysiology, diagnosis and treatment. Nat Rev Neurol. 2019;15(9):519-539. doi:10.1038/s41582-019-0226-9
6 Global Narcolepsy Drugs Market, Forecast 2019-2025. Allied Market Research.
Alkermes Contacts:
For Investors: Sandy Coombs, +1 781 609 6377
For Media: Gretchen Murphy, +1 781 609 6419
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