–– Study Designed to Characterize Potential
Metabolic Benefits of ALKS 3831 Compared to Olanzapine ––
–– Metabolic Study is a Supportive Study in the
ENLIGHTEN Pivotal Program for ALKS 3831, a Novel, Once-Daily, Oral
Antipsychotic in Development for the Treatment of Schizophrenia
––
Alkermes plc (NASDAQ: ALKS) today announced the initiation of a
clinical study designed to evaluate the metabolic profile of ALKS
3831, an investigational, novel, oral atypical antipsychotic drug
candidate, compared to olanzapine, an established atypical
antipsychotic agent with proven efficacy but also metabolic
liabilities, including significant weight gain. The randomized,
double-blind, parallel-group study will characterize metabolic
parameters, including insulin sensitivity and lipid metabolism, in
response to treatment with ALKS 3831 and olanzapine. This
exploratory metabolic study in healthy subjects is a supportive
study in the ENLIGHTEN pivotal program of ALKS 3831 for the
treatment of schizophrenia. The two key phase 3 studies,
ENLIGHTEN-1 and ENLIGHTEN-2, have been enrolling patients since
December 2015 and February 2016, respectively.
The objective of the newly-initiated metabolic study is to more
fully characterize the comparative metabolic effects of ALKS 3831
and olanzapine, in order to understand the potential metabolic
benefits of ALKS 3831 and to build on the findings from previously
conducted preclinical and clinical studies that suggest treatment
with ALKS 3831 is associated with less weight gain compared to
olanzapine. ALKS 3831 is designed to provide patients with the
strong efficacy of olanzapine with favorable weight and metabolic
properties.
“With the ENLIGHTEN clinical program, we are assessing the
potential for ALKS 3831 to address the compelling opportunity to
develop an antipsychotic with the efficacy of olanzapine and a
safety profile that addresses the negative health impact of
significant weight gain and metabolic consequences associated with
olanzapine,” said Elliot Ehrich, M.D., Chief Medical Officer of
Alkermes. “The initiation of this metabolic study represents our
continued progress in advancing ALKS 3831 through pivotal
development. As a novel, oral antipsychotic created based on the
real-world needs of patients, ALKS 3831 has the potential to offer
a meaningful new treatment option for schizophrenia.”
The phase 1 metabolic study will assess the effects of ALKS 3831
on whole body insulin sensitivity, lipid metabolism and other
important metabolic parameters compared to olanzapine.
Approximately 50 healthy subjects will be randomized to receive
ALKS 3831, olanzapine or placebo for 21 days. Results from the
study are expected in the first half of 2017.
About the ENLIGHTEN Clinical
Program
The ENLIGHTEN pivotal program for ALKS 3831 is comprised of two
key studies: a study evaluating the antipsychotic efficacy of ALKS
3831 compared to placebo over four weeks and a study assessing
weight gain with ALKS 3831 compared to olanzapine in patients with
schizophrenia over six months. The program also includes supportive
studies to evaluate the pharmacokinetic and metabolic profile of
ALKS 3831, as well as long-term safety. Alkermes expects to use
safety and efficacy data from the ENLIGHTEN pivotal program to
serve as the basis for a New Drug Application (NDA) to be submitted
to the U.S. Food and Drug Administration (FDA), pending study
results.
Further information about the ENLIGHTEN studies can be found at
www.clinicaltrials.gov.
About ALKS 3831
ALKS 3831 is a proprietary, investigational medicine designed as
a broad-spectrum antipsychotic for the treatment of schizophrenia.
ALKS 3831 is composed of samidorphan, a novel, new molecular entity
co-formulated with the established antipsychotic agent, olanzapine,
in a single bilayer tablet.
Weight gain is a common and clinically relevant metabolic side
effect of atypical antipsychotic medications, and olanzapine,
commercially available as ZYPREXA®, has one of the highest
incidences and greatest amounts of weight gain among the widely
prescribed products in this class of drugs.1 ALKS 3831 is designed
to provide the strong efficacy of olanzapine and a differentiated
safety profile with favorable weight and metabolic properties.
ALKS 3831 is also being evaluated for the treatment of
schizophrenia in patients with co-occurring alcohol use disorder. A
phase 2 study, initiated in June 2014, is investigating the
potential utility of ALKS 3831 for the large number of patients
with schizophrenia whose disease is exacerbated by alcohol use
disorders – a group representing more than one-third of patients
with schizophrenia.2
About Schizophrenia
Schizophrenia is a chronic, severe and disabling brain disorder.
The disease is marked by positive symptoms (hallucinations and
delusions) and negative symptoms (depression, blunted emotions and
social withdrawal), as well as by disorganized thinking. An
estimated 2.4 million American adults have schizophrenia,3 with men
and women affected equally. Worldwide, it is estimated that one
person in every 100 develops schizophrenia, which is one of the
most serious types of mental illness.
About Alkermes
Alkermes plc is a fully integrated, global
biopharmaceutical company developing innovative medicines for the
treatment of central nervous system (CNS) diseases. The company has
a diversified commercial product portfolio and a substantial
clinical pipeline of product candidates for chronic diseases that
include schizophrenia, depression, addiction and multiple
sclerosis. Headquartered in Dublin, Ireland, Alkermes plc has an
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.
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 therapeutic value,
development plans and commercial potential of ALKS 3831; the
adequacy of the phase 1 metabolic study to assess the metabolic
parameters and comparative metabolic effect of ALKS 3831 and
olanzapine; and the adequacy of the ENLIGHTEN pivotal program for
ALKS 3831 to serve as the basis for an NDA. You are cautioned 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 preclinical and
clinical results for ALKS 3831 will be predictive of future
clinical study results; whether the ongoing phase 2 trial, the
phase 1 metabolic study and the ENLIGHTEN pivotal trials for ALKS
3831 will be completed on time or at all; if the results of the
phase 1 metabolic study will show favorable metabolic effects of
ALKS 3831 compared to olanzapine; potential changes in cost, scope
and duration of the ALKS 3831 clinical development program; whether
ALKS 3831 could be shown ineffective or unsafe during clinical
studies; and those risks and uncertainties described in Item 1A
under the heading “Risk Factors” in the company’s Annual Report on
Form 10-K for the fiscal year ended Dec. 31, 2015, and in any other
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 they are made. The information
contained in this press release is provided by the company as of
the date hereof, and, except as required by law, the company
disclaims any intention or responsibility for updating or revising
any forward-looking information contained in this press
release.
ZYPREXA® is a registered trademark of Eli Lilly &
Company.
1Komossa, K. et al. Olanzapine versus other atypical
antipsychotics for schizophrenia. Cochrane Database of Systematic
Reviews. 2010, Issue 3. Art. No.: CD006654.
2Regier, D. et al. Comorbidity of Mental Disorders With Alcohol
and Other Drug Abuse. JAMA. 1990, 264: 2511-2518.
3National Institutes of Health. Schizophrenia. Accessed on Sept.
30, 2016 from
http://report.nih.gov/NIHfactsheets/ViewFactSheet.aspx?csid=67&key=S#S.
View source
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Alkermes plcFor Investors:Eva Stroynowski, +1
781-609-6823orSandy Coombs, +1 781-609-6377orFor Media:Jennifer
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