Alkermes to Present Positive Clinical Data From Phase 1b Study of ALKS 2680 in Patients With Narcolepsy Type 2 and Idiopathic Hypersomnia at Sleep Europe 2024
Alkermes plc (Nasdaq: ALKS) announced plans to present clinical data from its phase 1b study of ALKS 2680 in patients with narcolepsy type 2 (NT2) and idiopathic hypersomnia (IH) at Sleep Europe 2024. ALKS 2680 is an investigational, oral, selective orexin 2 receptor agonist for narcolepsy treatment. The company will share data from NT2 (n=9) and IH (n=8) patient cohorts, where ALKS 2680 was generally well tolerated with improved wakefulness compared to placebo.
Alkermes will also present posters on the study design for ongoing phase 2 studies, Vibrance-1 and Vibrance-2, evaluating ALKS 2680 in narcolepsy type 1 and type 2 patients. The phase 1b study results support further clinical evaluation of ALKS 2680 as a potential treatment for sleep disorders with and without known orexin deficiency.
Alkermes plc (Nasdaq: ALKS) ha annunciato piani per presentare i dati clinici dal suo studio di fase 1b su ALKS 2680 in pazienti con narcolessia di tipo 2 (NT2) e ipersomnia idiopatica (IH) a Sleep Europe 2024. ALKS 2680 è un agonista selettivo del recettore dell'orexina 2, orale e in fase di sperimentazione, per il trattamento della narcolessia. L'azienda condividerà dati dai gruppi di pazienti NT2 (n=9) e IH (n=8), dove ALKS 2680 è stato generalmente ben tollerato con un miglioramento della vigilanza rispetto al placebo.
Alkermes presenterà anche poster sul design dello studio per gli attuali studi di fase 2, Vibrance-1 e Vibrance-2, che valutano ALKS 2680 in pazienti con narcolessia di tipo 1 e tipo 2. I risultati dello studio di fase 1b supportano una ulteriore valutazione clinica di ALKS 2680 come potenziale trattamento per i disturbi del sonno con e senza carenza nota di orexina.
Alkermes plc (Nasdaq: ALKS) anunció planes para presentar datos clínicos de su estudio de fase 1b de ALKS 2680 en pacientes con narcolepsia tipo 2 (NT2) e hipersomnia idiopática (IH) en Sleep Europe 2024. ALKS 2680 es un agonista selectivo del receptor de orexina 2, oral y en investigación, para el tratamiento de la narcolepsia. La compañía compartirá datos de los grupos de pacientes de NT2 (n=9) e IH (n=8), donde ALKS 2680 fue generalmente bien tolerado con una mejora en la vigilia en comparación con el placebo.
Alkermes también presentará carteles sobre el diseño del estudio de los actuales estudios de fase 2, Vibrance-1 y Vibrance-2, que evalúan ALKS 2680 en pacientes con narcolepsia tipo 1 y tipo 2. Los resultados del estudio de fase 1b apoyan una evaluación clínica adicional de ALKS 2680 como un posible tratamiento para trastornos del sueño con y sin deficiencia de orexina conocida.
Alkermes plc (Nasdaq: ALKS)는 Sleep Europe 2024에서 나르코렙시 타입 2 (NT2) 및 특발성 과잠 (IH) 환자에서의 ALKS 2680에 대한 1b 단계 연구의 임상 데이터를 발표할 계획을 발표했습니다. ALKS 2680은 나르코렙시 치료를 위한 경구용 선택적 오렉신 2 수용체 작용제입니다. 회사는 NT2 (n=9) 및 IH (n=8) 환자 집단의 데이터를 공유할 예정이며, 여기서 ALKS 2680은 위약 대비 일반적으로 잘 견뎌졌으며 각성도가 향상되었습니다.
Alkermes는 또한 나르코렙시 타입 1 및 타입 2 환자에서 ALKS 2680을 평가하는 현재 진행 중인 2단계 연구인 Vibrance-1과 Vibrance-2의 연구 설계에 대한 포스터를 발표할 예정입니다. 1b 단계 연구 결과는 오렉신 결핍이 있는 경우와 없는 경우의 수면 장애에 대한 잠재적 치료제로서 ALKS 2680의 추가 임상 평가를 지원합니다.
Alkermes plc (Nasdaq: ALKS) a annoncé des plans pour présenter des données cliniques de son étude de phase 1b sur ALKS 2680 chez des patients atteints de narcolepsie de type 2 (NT2) et d'hypersomnie idiopathique (IH) lors de Sleep Europe 2024. ALKS 2680 est un agoniste sélectif du récepteur de l'orexine 2, oral et en phase d'investigation, pour le traitement de la narcolepsie. L'entreprise partagera des données des cohortes de patients NT2 (n=9) et IH (n=8), où ALKS 2680 a été généralement bien toléré avec une amélioration de la vigilance par rapport au placebo.
Alkermes présentera également des affiches sur le design de l'étude pour les études de phase 2 en cours, Vibrance-1 et Vibrance-2, évaluant ALKS 2680 chez des patients atteints de narcolepsie de type 1 et de type 2. Les résultats de l'étude de phase 1b soutiennent une évaluation clinique supplémentaire d'ALKS 2680 en tant que traitement potentiel pour les troubles du sommeil avec et sans carence connue en orexine.
Alkermes plc (Nasdaq: ALKS) hat Pläne angekündigt, klinische Daten aus seiner Phase-1b-Studie zu ALKS 2680 bei Patienten mit Narcolepsie Typ 2 (NT2) und idiopathischer Hypersomnie (IH) auf der Sleep Europe 2024 zu präsentieren. ALKS 2680 ist ein experimenteller, oraler, selektiver Agonist des Orexin-2-Rezeptors zur Behandlung von Narcolepsie. Das Unternehmen wird Daten aus den Patientengruppen NT2 (n=9) und IH (n=8) teilen, in denen ALKS 2680 allgemein gut vertragen wurde und die Wachsamkeit im Vergleich zu Placebo verbessert wurde.
Alkermes wird auch Poster zum Studiendesign der laufenden Phase-2-Studien, Vibrance-1 und Vibrance-2, vorstellen, die ALKS 2680 bei Patienten mit Narcolepsie Typ 1 und Typ 2 evaluieren. Die Ergebnisse der Phase-1b-Studie unterstützen eine weitere klinische Bewertung von ALKS 2680 als potenzielle Behandlung für Schlafstörungen mit und ohne bekannte Orexinmangel.
- ALKS 2680 showed improved wakefulness compared to placebo in both NT2 and IH patient cohorts
- ALKS 2680 was generally well tolerated in the phase 1b study
- Results support further clinical evaluation of ALKS 2680 for sleep disorders
- Ongoing phase 2 studies (Vibrance-1 and Vibrance-2) are evaluating ALKS 2680 in narcolepsy type 1 and type 2 patients
- None.
̶ Data From Narcolepsy Type 2 Cohort of ALKS 2680 Phase 1b Study to be Presented in Oral Presentation ̶
̶ Data From Idiopathic Hypersomnia Cohort of ALKS 2680 Phase 1b Study Accepted for Poster Presentation ̶
In an oral presentation and corresponding poster presentation, the company will share data from the cohort of patients with NT2 (n=9) from the phase 1b, proof-of-concept study evaluating single-dose, oral administration of ALKS 2680. Additionally, the company will present a poster with data from the cohort of patients with IH (n=8) from the same study. As previously announced, ALKS 2680 was generally well tolerated with improved wakefulness compared to placebo in both cohorts.
"Results from the ALKS 2680 phase 1b proof-of-concept study in patients with narcolepsy type 1, narcolepsy type 2 and idiopathic hypersomnia highlight the potential of ALKS 2680 as a treatment option for people living with these sleep disorders, both with and without known orexin deficiency. Treatment with once-daily, oral ALKS 2680 was generally well tolerated with improved wakefulness compared to placebo at all doses tested across all three patient populations, supporting further clinical evaluation," said Ron Grunstein, M.D., Ph.D., Head of Sleep and Circadian Research at the Woolcock Institute of Medical Research.
The company will also present two posters at Sleep Europe 2024 detailing the study design and methods for each of the ongoing phase 2 studies, Vibrance-1 and Vibrance-2, evaluating ALKS 2680 in patients with narcolepsy type 1 and narcolepsy type 2, respectively.
"We're pleased to share the results from our ALKS 2680 phase 1b, proof-of-concept study in patients with narcolepsy type 2 and idiopathic hypersomnia at Sleep Europe 2024. These data provide further evidence of the clinical profile of ALKS 2680 in patients with sleep disorders and a strong foundation to advance the ALKS 2680 phase 2 program," said Craig Hopkinson, M.D., Chief Medical Officer and Executive Vice President of Research & Development at Alkermes. "We look forward to engaging with clinicians and researchers at this important meeting, sharing the data from our clinical development program, and discussing the design of the ongoing phase 2 studies, Vibrance-1 and Vibrance-2, which are evaluating ALKS 2680 in patients with narcolepsy type 1 and type 2, respectively."
Details of Alkermes' presentations at Sleep Europe 2024 are as follows:
The Orexin 2 Receptor Agonist ALKS 2680 in Patients with Narcolepsy Type 2: An Initial Proof of Concept Phase 1b Study
- Presenter: Ron Grunstein, M.D., Ph.D., Head of Sleep and Circadian Research at the Woolcock Institute of Medical Research
- Presentation Date: The oral presentation is scheduled to occur on Wednesday, Sept. 25, 2024 at 8:00 CEST as part of Oral Session 1 and will be available online to registered attendees. The corresponding poster (P200) will be presented on Wednesday, Sept. 25, 2024 from 16:00–17:45 CEST.
The Orexin 2 Receptor Agonist ALKS 2680 in Patients with Idiopathic Hypersomnia: An Initial Proof of Concept Phase 1b Study
- Poster ID: P5070
- Presenter: Brendon Yee, Ph.D., Professor and Respiratory and Sleep Physician at the Woolcock Institute of Medical Research
- Presentation Date: The poster will be presented on Thursday, Sept. 26, 2024 from 17:30–18:45 CEST.
Vibrance-1: Study Design and Methods for a Phase 2, Randomised, Placebo-Controlled, Parallel Group Study Evaluating the Safety and Efficacy of ALKS 2680 in Patients With Narcolepsy Type 1
- Poster ID: P797
- Presenter: Giuseppe Plazzi, M.D., Ph.D., Head of the Sleep Center at the Institute of Neurological Sciences of
Bologna, Italy and Chair of Child Neurology at the University of Modena andReggio Emilia - Presentation Date: The poster will be presented on Thursday, Sept. 26, 2024 from 17:30–19:00 CEST.
Vibrance-2: Study Design and Methods for a Phase 2, Randomised, Placebo-Controlled, Parallel Group Study Evaluating the Safety and Efficacy of ALKS 2680 in Patients With Narcolepsy Type 2
- Poster ID: P5071
- Presenter: Sergey Yagoda, M.D., Ph.D., Alkermes
- Presentation Date: The poster will be presented on Thursday, Sept. 26, 2024 from 17:30–18:45 CEST.
For more information, including a complete list of abstracts, please visit the ESRS Congress website at https://esrs.eu/sleep-congress/.
About the ALKS 2680 Phase 1 Study
The phase 1 study for ALKS 2680 included single-ascending dose and multiple-ascending dose evaluations in healthy volunteers, and double-blind, crossover treatment in patients with NT1, NT2 and IH.
In the healthy volunteer phase of the study, each cohort included eight participants, six of whom were randomized to receive ALKS 2680 and two of whom received placebo. In the single-dose portion, ALKS 2680 was dosed from 1 mg to 50 mg. In the multiple-dose portion, participants received single daily doses of ALKS 2680 ranging from 3 mg to 25 mg strengths for up to 10 days. The objectives of this part of the study were to assess ALKS 2680's safety, tolerability, pharmacokinetics (PK) and pharmacodynamics.
The phase 1b proof-of-concept part of the study enrolled patients with NT1 (n=10), NT2 (n=9) or IH (n=8). Following an initial two-week washout period of existing medications, patients received single doses of three active dose levels of ALKS 2680 (1 mg, 3 mg and 8 mg for NT1; 5 mg, 12 mg and 25 mg for NT2 and IH) and placebo in a randomized sequence in a four-way crossover design, with washout periods between each treatment in the sequence. The objectives were to assess safety and tolerability, and changes from baseline in average sleep latency, as measured through the Maintenance of Wakefulness Test (MWT) at each crossover period, along with plasma PK, and patient-reported measures of alertness on the Karolinska Sleepiness Scale (KSS).
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 NT1, NT2 and IH, and is currently being evaluated in the phase 2 Vibrance-1 and Vibrance-2 studies in patients with NT1 and NT2, respectively.
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
Alkermes Contacts: | ||
For Investors: | Sandy Coombs, | +1 781 609 6377 |
For Media: | Gretchen Murphy, | +1 781 609 6419 |
View original content to download multimedia:https://www.prnewswire.com/news-releases/alkermes-to-present-positive-clinical-data-from-phase-1b-study-of-alks-2680-in-patients-with-narcolepsy-type-2-and-idiopathic-hypersomnia-at-sleep-europe-2024-302254991.html
SOURCE Alkermes plc
FAQ
What is ALKS 2680 and what is it being developed for?
What were the results of the ALKS 2680 phase 1b study in narcolepsy type 2 and idiopathic hypersomnia patients?
What are the next steps for ALKS 2680 clinical development?
When and where will Alkermes present the ALKS 2680 phase 1b study results?
