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–– Topline Results From ENLIGHTEN-1 Study Expected Mid-2017 ––
“There is a clear and compelling clinical rationale for developing an
antipsychotic with the powerful efficacy of olanzapine while addressing
the significant weight gain associated with its use,” said
ENLIGHTEN-2, the second key study from the ENLIGHTEN development program
for ALKS 3831, is ongoing and enrolling patients with data expected
mid-2018. The study is designed to evaluate the weight gain profile of
ALKS 3831 in patients with schizophrenia over a six-month treatment
period compared to olanzapine. The clinical data from the ENLIGHTEN-1
and ENLIGHTEN-2 studies, if successful, will form the basis of a New
Drug Application (NDA) to be submitted to the
About the ENLIGHTEN Clinical Development Program
The ENLIGHTEN clinical development 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 antipsychotic efficacy of olanzapine and a differentiated safety profile with favorable weight and metabolic properties.
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,2 with men and women affected equally.
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 timing of receipt and reporting
of the ENLIGHTEN-1 and ENLIGHTEN-2 study results; the therapeutic value,
development plans and commercial potential of ALKS 3831; and the
adequacy of the ENLIGHTEN clinical development program to serve as the
basis for an NDA for ALKS 3831. 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 ENLIGHTEN key studies for ALKS 3831 will be
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 and uncertainties described under the heading “Risk Factors”
in the company’s Annual Report on Form 10-K for the 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.
Eva Stroynowski, +1 781-609-6823
Sandy Coombs, +1 781-609-6377
Jennifer Snyder, +1 781-609-6166