–– Study Designed to Characterize Potential Metabolic Benefits of ALKS 3831 Compared to Olanzapine ––
–– Metabolic Study is a Supportive Study in the
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
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.
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
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
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
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.
3
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Alkermes plc
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