– Late-Breaking Abstracts Containing Data From
the Full Narcolepsy Type 1 Cohort From the ALKS 2680 Phase
1b Study and Vibrance-1 Phase 2 Study
Design Accepted for Poster Presentations –
– Findings From In-Depth Qualitative Patient
Interviews on the Burden of Narcolepsy Will Also Be Presented
–
DUBLIN, May 28, 2024
/PRNewswire/ -- Alkermes plc (Nasdaq: ALKS) today announced plans
to present three posters related to ALKS 2680 at SLEEP 2024, the
38th annual meeting of the Associated Professional Sleep
Societies (APSS), taking place June 1-5,
2024 in Houston. ALKS 2680
is the company's novel, investigational, oral orexin 2 receptor
(OX2R) agonist in development as a once-daily treatment for
narcolepsy.
The company will present two posters during a late-breaking
abstract session:
- Data from the full cohort (n=10)1 of patients with
narcolepsy type 1 (NT1) from the phase 1b, proof-of-concept study evaluating single dose
oral administration of ALKS 2680. Safety results and
pharmacodynamic efficacy assessments evaluating objective
(Maintenance of Wakefulness Test [MWT]) and subjective
patient-reported (Karolinska Sleepiness Scale [KSS]) measures of
sleepiness will be presented.
- Study design and methods for the Vibrance-1 study, a recently
initiated phase 2 clinical trial evaluating the safety and efficacy
of ALKS 2680 compared to placebo in patients with NT1.
In addition, findings from in-depth, qualitative interviews with
patients with NT1 (n=12) and narcolepsy type 2 (NT2) (n=10) will be
presented. During the 60-minute interviews, participants described
the impact and burden of disease on many facets of their lives,
including work and school activities, mental health, activities of
daily living and relationships.
"We have made significant progress in the ALKS 2680 program in
the last year, including generating proof-of-concept data that
validated our design hypothesis and enabled us to initiate our
Vibrance-1 phase 2 study in patients with narcolepsy type 1," said
Craig Hopkinson, M.D., Chief Medical
Officer and Executive Vice President, Research & Development at
Alkermes. "We are excited to present data from the full narcolepsy
type 1 cohort from our phase 1b study
and qualitative findings that bring to light new insights from
patients that demonstrate the breadth of impacts narcolepsy can
have on patients' lives. We look forward to engaging with the sleep
community at this important scientific meeting."
Details of Alkermes' presentations at SLEEP 2024 are as
follows:
"Safety and Pharmacodynamic Effects of the Orexin 2 Receptor
Agonist ALKS 2680 in Patients with Narcolepsy Type 1: A
First-in-Human Phase 1 Study"
- Abstract ID: 1323
- Poster Board Number: 423
- Presenter: Ron Grunstein,
M.D., Ph.D., Head of Sleep and Circadian Research at the Woolcock
Institute of Medical Research
- Presentation Date: The poster will be presented on
Tuesday, June 4, 2024 from
10:00–10:45 a.m. CT, during session P-31.
"Vibrance-1: Study Design and Methods for a Phase 2,
Randomized, Placebo-Controlled, Parallel Group Study Evaluating the
Safety and Efficacy of ALKS 2680 in Patients With Narcolepsy Type
1"
- Abstract ID: 1363
- Poster Board Number: 462
- Presenter: David T.
Plante, M.D., Ph.D., Associate Professor of Psychiatry at
the University of
Wisconsin-Madison
- Presentation Date: The poster will be presented on
Tuesday, June 4, 2024 from
11:00–11:45 a.m. CT, during session P-31.
"The Burden of Living with Narcolepsy: Patient Perspectives
from In-Depth Qualitative Interviews"
- Abstract ID: 673
- Poster Board Number: 302
- Presenter: Michael J.
Doane, Ph.D., Alkermes
- Presentation Date: The poster will be presented on
Wednesday, June 5, 2024 from
11:00–11:45 a.m. CT, during session P-42.
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 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.2 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 was previously evaluated in a
phase 1 study in healthy volunteers and people living with
narcolepsy type 1, narcolepsy type 2 and idiopathic hypersomnia and
is currently being evaluated in a phase 2 study in patients with
narcolepsy type 1.
About the Vibrance-1 Study
Vibrance-1 is a phase 2,
randomized, double-blind, dose-range-finding study evaluating the
safety and efficacy of ALKS 2680 compared to placebo in patients
with narcolepsy type 1. More information can be found at
www.clinicaltrials.gov (identifier: NCT06358950) and
www.vibrancestudies.com (for U.S. audiences only).
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 Ireland, Alkermes
also has a corporate office and research and development center in
Massachusetts and a manufacturing
facility in Ohio. For more
information, please visit Alkermes' website at
www.alkermes.com.
1
Data from the first four patients with NT1 in this phase 1b study
were previously presented at the 2023 World Sleep Congress.
|
2 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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SOURCE Alkermes plc