DUBLIN, April 24,
2024 /PRNewswire/ -- Alkermes plc (Nasdaq: ALKS)
today announced initiation of the Vibrance-1 study, a phase 2
clinical trial evaluating the safety and efficacy of ALKS 2680
compared to placebo in patients with narcolepsy type 1 (NT1). ALKS
2680 is the company's novel, investigational, oral orexin 2
receptor (OX2R) agonist in development as a once-daily treatment
for narcolepsy, a chronic, neurological disorder characterized by
excessive daytime sleepiness. NT1 is associated with an absence or
significant deficiency in orexin levels, and the presence of
cataplexy, a sudden loss of muscle tone triggered by strong
emotions.
"ALKS 2680 offers the potential to harness the orexin system,
the master regulator of wakefulness, by addressing the loss of
orexin signaling common in people with narcolepsy type 1. Based on
data from our phase 1, proof-of-concept study, we are excited to
advance this novel oral compound to phase 2," said Craig Hopkinson, M.D., Chief Medical Officer and
Executive Vice President, Research & Development at Alkermes.
"Initiation of the Vibrance-1 study is a significant milestone for
the ALKS 2680 development program, and we look forward to further
characterizing ALKS 2680's safety and efficacy profile throughout
this phase 2 study."
Vibrance-1 is a phase 2, randomized, double-blind,
dose-range-finding, placebo-controlled study evaluating the safety
and efficacy of ALKS 2680 in people with NT1. Participants will be
randomized to receive one of three doses of ALKS 2680 (4 mg, 6 mg
or 8 mg) or placebo to be taken once-daily for six 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, mean weekly cataplexy rate (WCR) and incidence of
adverse events. The study is expected to enroll approximately
80 patients with NT1 across sites in the U.S., Australia and Europe. All participants in the double-blind
portion of the study will be eligible to continue in the open-label
safety extension portion of the study.
More information can be found at
www.clinicaltrials.gov (identifier: NCT06358950) and
www.vibrancestudies.com (for U.S. audiences only).
The company expects to initiate Vibrance-2, a planned phase 2
study in patients with narcolepsy type 2, in the second half of
2024.
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.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 was
previously evaluated in a phase 1 study in healthy volunteers and
people living with narcolepsy type 1, narcolepsy type 2 and
idiopathic hypersomnia.
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. Headquartered
in Dublin, Ireland, Alkermes has a
research and development 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.
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 plans and timelines for
clinical development activities for ALKS 2680, including study
design and initiation of a phase 2 study in patients with
narcolepsy type 2. 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 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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