Alkermes Announces Initiation of Vibrance-3 Phase 2 Study Evaluating ALKS 2680 for the Treatment of Idiopathic Hypersomnia
Alkermes (ALKS) has launched Vibrance-3, a Phase 2 clinical study evaluating ALKS 2680 for idiopathic hypersomnia (IH). The study will assess the safety and efficacy of their novel oral selective orexin 2 receptor agonist versus placebo in adults with IH.
The randomized, double-blind trial will enroll approximately 96 patients across U.S., Australia, and Europe sites. Participants will receive one of three doses (10mg, 14mg, or 18mg) or placebo once-daily for eight weeks. The primary endpoint measures decrease in sleepiness using the Epworth Sleepiness Scale score.
This development follows encouraging Phase 1b data and addresses a significant unmet need, as over 90% of patients in a recent Sleep Consortium survey reported moderate to high impact of IH symptoms on their lives. IH affects an estimated 40,000 people in America.
Alkermes (ALKS) ha lanciato Vibrance-3, uno studio clinico di Fase 2 che valuta ALKS 2680 per l'ipersonnia idiopatica (IH). Lo studio valuterà la sicurezza e l'efficacia del loro nuovo agonista selettivo del recettore dell'orexina 2 per via orale rispetto al placebo in adulti con IH.
Il trial randomizzato, in doppio cieco, arruolerà circa 96 pazienti in siti negli Stati Uniti, in Australia e in Europa. I partecipanti riceveranno una delle tre dosi (10mg, 14mg o 18mg) o placebo una volta al giorno per otto settimane. L'obiettivo primario misura la diminuzione della sonnolenza utilizzando il punteggio della Scala di Sonnolenza di Epworth.
Questo sviluppo segue dati incoraggianti della Fase 1b e affronta un bisogno significativo non soddisfatto, poiché oltre il 90% dei pazienti in un recente sondaggio del Sleep Consortium ha riportato un impatto moderato o elevato dei sintomi dell'IH sulle loro vite. L'IH colpisce circa 40.000 persone in America.
Alkermes (ALKS) ha lanzado Vibrance-3, un estudio clínico de Fase 2 que evalúa ALKS 2680 para la hipersomnia idiopática (IH). El estudio evaluará la seguridad y eficacia de su nuevo agonista oral selectivo del receptor de orexina 2 frente al placebo en adultos con IH.
El ensayo aleatorizado y doble ciego inscribirá aproximadamente 96 pacientes en sitios de EE. UU., Australia y Europa. Los participantes recibirán una de tres dosis (10mg, 14mg o 18mg) o placebo una vez al día durante ocho semanas. El objetivo primario mide la disminución de la somnolencia utilizando la puntuación de la Escala de Somnolencia de Epworth.
Este desarrollo sigue datos alentadores de la Fase 1b y aborda una necesidad significativa no satisfecha, ya que más del 90% de los pacientes en una reciente encuesta del Sleep Consortium informaron un impacto moderado a alto de los síntomas de IH en sus vidas. La IH afecta a aproximadamente 40,000 personas en América.
알케르메스 (ALKS)는 특발성 과다수면증(IH)을 위한 ALKS 2680을 평가하는 2상 임상 시험인 Vibrance-3를 출시했습니다. 이 연구는 IH를 앓고 있는 성인에서 새로운 경구용 선택적 오렉신 2 수용체 작용제의 안전성과 효능을 위약과 비교하여 평가할 것입니다.
무작위 이중 맹검 시험은 미국, 호주 및 유럽의 사이트에서 약 96명의 환자를 모집할 예정입니다. 참가자들은 10mg, 14mg 또는 18mg의 세 가지 용량 중 하나 또는 위약을 하루에 한 번 8주 동안 복용하게 됩니다. 주요 평가 기준은 에포스 수면 척도를 사용하여 졸림의 감소를 측정합니다.
이 개발은 유망한 1b상 데이터를 바탕으로 하며, 최근 Sleep Consortium 설문조사에서 90% 이상의 환자가 IH 증상이 자신의 삶에 중간에서 높은 영향을 미친다고 보고한 중요한 충족되지 않은 요구를 다룹니다. IH는 미국에서 약 40,000명에게 영향을 미칩니다.
Alkermes (ALKS) a lancé Vibrance-3, une étude clinique de Phase 2 évaluant ALKS 2680 pour l'hypersomnie idiopathique (IH). L'étude évaluera la sécurité et l'efficacité de leur nouvel agoniste oral sélectif du récepteur d'orexine 2 par rapport à un placebo chez des adultes atteints d'IH.
L'essai randomisé en double aveugle recrutera environ 96 patients dans des sites aux États-Unis, en Australie et en Europe. Les participants recevront l'une des trois doses (10mg, 14mg ou 18mg) ou un placebo une fois par jour pendant huit semaines. L'objectif principal mesure la diminution de la somnolence à l'aide du score de l'Échelle de Somnolence d'Epworth.
Ce développement fait suite à des données encourageantes de la Phase 1b et répond à un besoin non satisfait important, car plus de 90 % des patients dans une récente enquête du Sleep Consortium ont signalé un impact modéré à élevé des symptômes de l'IH sur leur vie. L'IH touche environ 40 000 personnes en Amérique.
Alkermes (ALKS) hat Vibrance-3 gestartet, eine Phase-2-Studie, die ALKS 2680 zur idiopathischen Hypersomnie (IH) evaluiert. Die Studie wird die Sicherheit und Wirksamkeit ihres neuartigen oralen selektiven Orexin-2-Rezeptor-Agonisten im Vergleich zu Placebo bei Erwachsenen mit IH bewerten.
Die randomisierte, doppelblinde Studie wird voraussichtlich etwa 96 Patienten an Standorten in den USA, Australien und Europa einschließen. Die Teilnehmer erhalten eine von drei Dosen (10mg, 14mg oder 18mg) oder Placebo einmal täglich über einen Zeitraum von acht Wochen. Der primäre Endpunkt misst die Verringerung der Schläfrigkeit anhand des Epworth-Schläfrigkeitsskala-Scores.
Diese Entwicklung folgt ermutigenden Daten der Phase 1b und adressiert einen erheblichen ungedeckten Bedarf, da über 90 % der Patienten in einer aktuellen Umfrage des Sleep Consortium berichteten, dass die Symptome der IH einen moderaten bis hohen Einfluss auf ihr Leben haben. IH betrifft schätzungsweise 40.000 Menschen in Amerika.
- Expansion of clinical pipeline with Phase 2 trial initiation addressing 40,000-patient market
- Strong market opportunity supported by 90% of surveyed patients reporting moderate to high symptom impact
- Encouraging Phase 1b proof-of-concept data supporting further development
- Comprehensive development program with parallel trials for multiple sleep disorders
- Early-stage development with no guaranteed success
- Significant R&D expenses with multiple ongoing Phase 2 trials
- Small target market of only 40,000 patients in America
Insights
Alkermes' initiation of the Vibrance-3 Phase 2 study for ALKS 2680 in idiopathic hypersomnia (IH) represents modest but meaningful pipeline progress in an underserved therapeutic area. This development follows positive signals from their Phase 1b proof-of-concept study and expands their orexin 2 receptor agonist program beyond the ongoing narcolepsy trials.
The study design includes three dose levels (10mg, 14mg, and 18mg) against placebo in approximately 96 patients with clearly defined endpoints measuring sleepiness reduction. What's particularly noteworthy is that they're targeting the estimated 40,000 Americans with idiopathic hypersomnia - a small but significant patient population with treatment options.
From a strategic perspective, Alkermes is establishing a comprehensive clinical program across related sleep disorders, suggesting confidence in their mechanistic approach. The orexin pathway represents a validated biological target for sleep disorders, though competition in this space is intensifying.
This announcement doesn't fundamentally alter Alkermes' near-term financial outlook but strengthens their CNS portfolio diversification beyond their established franchises in alcohol dependence, opioid dependence, schizophrenia and bipolar disorder. The high unmet need cited (90% of surveyed patients reporting moderate to high life impact) suggests potential for prioritized regulatory pathways if early efficacy signals prove robust.
"The initiation of Vibrance-3 represents an important step forward for the ALKS 2680 development program as we seek to advance a potential new treatment option for people living with idiopathic hypersomnia. There remains high unmet need for the idiopathic hypersomnia community, as evidenced by a recent survey conducted by the Sleep Consortium1 in which more than
Vibrance-3 is a phase 2, randomized, double-blind, dose-range-finding, placebo-controlled study evaluating the safety and efficacy of ALKS 2680 in adults with IH. 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, by dose level, whether participants taking ALKS 2680 experience a greater decrease in sleepiness compared to participants taking placebo alone, as measured by the change in Epworth Sleepiness Scale (ESS) score. Secondary endpoints include change in Idiopathic Hypersomnia Severity Scale (IHSS) score and incidence of adverse events. The study is expected to enroll approximately 96 patients with IH across sites in the
More information can be found at www.clinicaltrials.gov (identifier: NCT06843590) and www.vibrancestudies.com (for
Vibrance-1 and Vibrance-2, phase 2 studies evaluating the safety and efficacy of ALKS 2680 in adults with narcolepsy type 1 (NCT06358950) and narcolepsy type 2 (NCT06555783), respectively, are currently ongoing.
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 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.2 Targeting the orexin system may address excessive daytime sleepiness across hypersomnolence disorders, whether or not deficient orexin signaling is the underlying cause of disease.3 Once-daily oral administration of ALKS 2680 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 Idiopathic Hypersomnia
Idiopathic hypersomnia (IH) is a rare, chronic, neurological sleep disorder characterized by excessive daytime sleepiness despite normal sleep durations.4,5 Additional common symptoms can include severe sleep inertia (individuals may feel groggy or disoriented for prolonged periods after waking up), unrefreshing naps, fatigue and cognitive dysfunction.6,7 The underlying neuropathology of idiopathic hypersomnia is unknown.4 IH affects an estimated 40,000 people in America.8
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 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 ALKS 2680 for the treatment of narcolepsy and idiopathic hypersomnia; 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 studies or future stages of ongoing clinical studies 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, 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 The Illuminate Hypersomnia "Voice of the Patient" Report. Contains data from 811 survey respondents conducted in spring 2024.
2 Buysse, D. Diagnosis and assessment of sleep and circadian rhythm disorders. Journal of Psychiatric Practice. 2005; 11(2):102-115
3 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
4 Trotti LM, Arnulf I. Idiopathic Hypersomnia and Other Hypersomnia Syndromes. Neurotherapeutics. 2021;18(1):20-31. doi:10.1007/s13311-020-00919-1
5 American Academy of Sleep Medicine. The International Classification of Sleep Disorders. Third Edition (ICSD-3). 2014.
6 Trotti LM. Waking up is the hardest thing I do all day: Sleep inertia and sleep drunkenness. Sleep Med Rev 2016.
7 Vernet C, Leu-Semenescu S, Buzare MA, Arnulf I. Subjective symptoms in idiopathic hypersomnia: beyond excessive sleepiness. J Sleep Res. 2010;19:525–534
8 Acquavella et al., J Clin Sleep Med 16:1255 (2020)
Alkermes Contacts:
For Investors: Sandy Coombs, +1 781 609 6377
For Media: Gretchen Murphy, +1 781 609 6419
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FAQ
What is the primary endpoint of the ALKS Vibrance-3 Phase 2 study for idiopathic hypersomnia?
How many patients will the ALKS Vibrance-3 trial enroll and what are the dosing levels?
What is ALKS 2680 and how does it work for idiopathic hypersomnia?
How many Americans are affected by idiopathic hypersomnia that ALKS 2680 aims to treat?
What other conditions is ALKS 2680 being developed to treat besides idiopathic hypersomnia?
