–– ENLIGHTEN-2 Will Evaluate Weight Gain
Profile of Novel, Once-Daily, Oral Investigational Medicine
Compared to Olanzapine ––
Alkermes plc (NASDAQ: ALKS) today announced the initiation of
ENLIGHTEN-2, the second of two core phase 3 studies for ALKS 3831,
an investigational, novel, oral atypical antipsychotic drug
candidate designed to be a broad-spectrum treatment for
schizophrenia. ENLIGHTEN-2 will evaluate the weight gain profile of
ALKS 3831 in patients with schizophrenia over a six-month treatment
period compared to olanzapine, an established atypical
antipsychotic agent with proven efficacy but also metabolic
liabilities, including significant weight gain. ALKS 3831 is
designed to provide patients with the strong efficacy of olanzapine
and a differentiated safety profile with favorable weight and
metabolic properties.
“There is a clear and compelling clinical rationale for
developing an antipsychotic with the efficacy of olanzapine and a
safety profile that addresses the substantial negative health
impact of weight gain and metabolic consequences associated with
olanzapine,” said Elliot Ehrich, M.D., Chief Medical Officer of
Alkermes. “We are excited to continue to progress ALKS 3831 through
pivotal development as a new, oral antipsychotic designed with the
real-world needs of patients in mind and the potential to be a
meaningful new treatment option for patients suffering with
schizophrenia.”
ENLIGHTEN-2 is a multicenter, randomized, double-blind phase 3
study comparing weight gain of ALKS 3831 to olanzapine in
approximately 540 patients with stable schizophrenia over six
months. Safety and tolerability will also be evaluated in the
study. All participants in the double-blind portion of the study
will be eligible to continue in an open-label safety study of ALKS
3831 for an additional 12 months. The objective of the extension
phase of the study is to assess the safety and long-term
tolerability of once-daily, oral ALKS 3831.
About the ENLIGHTEN Clinical
Program
The ENLIGHTEN pivotal program for ALKS 3831 is comprised of two
key studies: a study evaluating ALKS 3831’s antipsychotic efficacy
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; 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 and the ENLIGHTEN pivotal trials
for ALKS 3831 will be initiated or completed on time or at all;
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
described in the Alkermes plc Quarterly Report on Form 10-Q for the
period ended Sept. 30, 2015 and Annual Report on Form 10-K for the
fiscal year ended Dec. 31, 2014, and in 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. 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 Feb.
9, 2016 from
http://report.nih.gov/NIHfactsheets/ViewFactSheet.aspx?csid=67&key=S#S.
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AlkermesFor Investors:Eva
Stroynowski, +1-781-609-6823orFor Media:Jennifer Snyder,
+1-781-609-6166
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