DUBLIN, Aug. 22, 2024 /PRNewswire/ -- Alkermes plc
(Nasdaq: ALKS) today announced initiation of the Vibrance-2 study,
a phase 2 clinical trial evaluating the safety and efficacy of ALKS
2680 compared to placebo in adults with narcolepsy type 2 (NT2).
ALKS 2680 is the company's novel, investigational, oral, selective
orexin 2 receptor (OX2R) agonist in development as a once-daily
treatment for narcolepsy, a chronic, neurological disorder
characterized by excessive daytime sleepiness.
"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 U.S., Australia and
Europe. All participants who
complete the double-blind portion of the study will be eligible to
continue in the open-label safety extension.
More information can be found at
www.clinicaltrials.gov (identifier: NCT06555783) and
www.vibrancestudies.com (for U.S. audiences only).
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 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.
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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