— Oral Presentation to Include Initial Clinical
Proof-of-Concept Data in Patients With Narcolepsy Type 1 for ALKS
2680, the Company's Investigational Orexin 2 Receptor Agonist
—
DUBLIN, Oct. 10, 2023 /PRNewswire/ -- Alkermes plc
(Nasdaq: ALKS) today announced plans to present new data related to
ALKS 2680, the company's novel, investigational orexin 2 receptor
(OX2R) agonist in development for the treatment of narcolepsy, at
World Sleep Congress, taking place Oct.
20-25, 2023, in Rio de
Janeiro. In an oral presentation, the company will present
initial data from its ongoing phase 1 study evaluating the safety,
tolerability, pharmacokinetics and pharmacodynamics of ALKS 2680 in
healthy volunteers and patients with narcolepsy or idiopathic
hypersomnia. This presentation will include initial clinical
proof-of-concept data from the first cohort of four patients with
narcolepsy type 1.
In a separate oral presentation, the company will share results
from a preclinical study evaluating the effect of ALKS 2680
(RDC-264177) on wakefulness and cataplexy in a mouse model of
narcolepsy type 1. In a poster presentation, the company will also
share findings from recently completed structured interviews
evaluating the diagnosis journey and symptoms of people living with
narcolepsy type 1 and type 2.
"The design and development of ALKS 2680 is grounded in
Alkermes' strong medicinal chemistry capabilities coupled with a
strong biological rationale for the use of orexin agonists in the
treatment of narcolepsy," said Craig
Hopkinson, M.D., Chief Medical Officer and Executive Vice
President of Research & Development at Alkermes. "As a leader
in the field of neuroscience, Alkermes is excited to leverage its
expertise in pursuit of the development of a potential new
treatment option for narcolepsy. We look forward to presenting data
at the World Sleep Congress, including our first clinical data for
ALKS 2680 in patients with narcolepsy."
Details of the presentations are as follows:
Oral presentations
- Abstract: #1600
- Title: Preliminary Results from a Phase 1 Study of
ALKS 2680, an Orexin 2 Receptor Agonist, in Healthy Participants
and Patients with Narcolepsy or Idiopathic Hypersomnia
- Presenter: Brendon
Yee, Ph.D., Woolcock Institute for Medical Research
- Presentation Date/Time: The oral presentation is
scheduled to occur on Oct. 23, 2023
during the Evidence-based approaches for optimizing
pharmacologic treatment for narcolepsy session (9:13 –
9:26 a.m. BRT).
- Abstract: #1337
- Title: Evaluation of a Novel, Orally Available
Orexin 2 Receptor Agonist, on Wakefulness and Cataplexy in a Mouse
Model of Type 1 Narcolepsy
- Presenter: Brian
Raymer, Ph.D., Alkermes
- Presentation Date/Time: The oral presentation is
scheduled to occur on Oct. 25, 2023
during the Risk factors for impact on brain function and
patient-reported consequences of narcolepsy session (9:00 –
9:13 a.m. BRT).
Poster presentation
- Abstract: #1329
- Title: Diagnosis and Symptoms of Narcolepsy from
the Patient Perspective: Results from In-Depth Qualitative
Interviews
- Presenter: Bhaskar Rege, Ph.D., Alkermes
- Presentation Date/Time: The poster presentation is
scheduled to occur on Oct. 23, 2023
during poster abstract group 2 (6:00 – 7:00
p.m. BRT).
About ALKS 2680
ALKS 2680 is a novel, investigational, oral, selective orexin 2
receptor (OX2R) agonist in development for the treatment of
narcolepsy. Orexin neuropeptides are important regulators of the
sleep/wake cycle through OX2R activation, and loss of orexinergic
neurons in the brain is associated with excessive daytime
sleepiness and cataplexy in narcolepsy.1 ALKS 2680 was
designed to address the underlying pathology of narcolepsy with the
goal of improving duration of wakefulness and providing cataplexy
control. Once-daily oral administration of ALKS 2680 is currently
being evaluated in a phase 1 study in healthy volunteers and people
living with narcolepsy type 1, narcolepsy type 2 and idiopathic
hypersomnia.
About Alkermes
Alkermes plc is a fully-integrated, global biopharmaceutical
company developing innovative medicines in the fields of
neuroscience and oncology. The company has a portfolio of
proprietary commercial products focused on alcohol dependence,
opioid dependence, schizophrenia and bipolar I disorder, and a
pipeline of product candidates in development for neurological
disorders and cancer. Headquartered in Dublin, Ireland, Alkermes has a research and
development (R&D) center in Waltham,
Massachusetts; a research and manufacturing facility in
Athlone, Ireland; and a
manufacturing facility in Wilmington,
Ohio. For more information, please visit Alkermes' website
at www.alkermes.com.
1 Nagahara T, Saitoh T, Kutsumura N, Irukayama-Tomobe
Y, Ogawa Y, Kuroda D, Gouda H, Kumagai H, Fujii H, Yanagisawa M,
Nagase H. Design and Synthesis of Non-Peptide, Selective Orexin
Receptor 2 Agonists. J Med Chem. 2015 Oct 22;58(20):7931-7. doi:
10.1021/acs.jmedchem.5b00988. Epub 2015 Aug 26. PMID: 26267383.
Alkermes Contacts:
For Investors: Sandy Coombs, +1 781 609 6377
For Media: Gretchen Murphy, +1 781 609 6419
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