— Novel Candidate for Treatment of Agitation in Alzheimer’s Disease Demonstrated Favorable Profile in First Clinical Trial —
— Company Accelerates Plans to Initiate Multiple-Dose Study —
Initiated in
“ALKS 7119 is an example of a promising new investigational medicine
that has emerged from our R&D engine into early clinical studies for an
important, chronic CNS disease. Based on the early data from this single
dose escalation study, we are excited to accelerate the development
program for ALKS 7119 into the multiple-ascending-dose study in healthy
volunteers which will begin in the third quarter,” commented
About ALKS 7119
ALKS 7119 is an
oral, novel, proprietary investigational medicine that has a multivalent
mechanism of action and acts on key receptors in the brain involved in
several central nervous system (CNS) diseases. In addition to the
potential treatment of agitation in patients with Alzheimer’s disease,
ALKS 7119 may be investigated for the treatment of major depressive
disorder and other psychiatric conditions. ALKS 7119 is a
N-methyl-D-aspartate (NMDA) receptor antagonist and a serotonin reuptake
inhibitor. It also binds to other targets, which may contribute to its
pharmacodynamic effects.
About Alzheimer’s Disease
Alzheimer’s
disease (AD) is a progressive brain disorder that slowly destroys memory
and thinking skills and, eventually, the ability to carry out the
simplest tasks.1 While cognitive decline is a central feature
of the disease, psychiatric symptoms, such as agitation, are the leading
source of morbidity and caregiver burden.2 There are
currently no approved medications in the U.S. for the treatment of
Alzheimer’s agitation. Approximately 5.3 million individuals in the U.S.
had AD in 2015, and this number is expected to nearly triple by 2050.3
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 7119. 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 preclinical and early
clinical results for ALKS 7119 will be predictive of future clinical
study results; whether future clinical trials for ALKS 7119 will be
completed on time or at all; changes in the cost, scope and duration of
the ALKS 7119 clinical trials; whether ALKS 7119 could be ineffective or
unsafe during clinical studies, and whether, in such instances,
1
2
3Alzheimer’s Association. Alzheimer’s Facts and Figures.
Accessed from http://www.alz.org/alzheimers_disease_facts_and_figures.asp#quickFacts
on
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Source:
Alkermes
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Sandy Coombs, +1-781-609-6377
or
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Media:
Jennifer Snyder, +1-781-609-6166