Alkermes Announces Initiation of Phase 1 Clinical Study of New CNS Drug Candidate ALKS 7119
25 January 2016 - 11:00PM
Business Wire
— Novel, Oral, Investigational Medicine for the
Treatment of Agitation in Alzheimer’s Disease and Other Psychiatric
Indications —
Alkermes plc (NASDAQ: ALKS) today announced the initiation of a
phase 1 clinical study of ALKS 7119, an oral, investigational drug
candidate being developed for the treatment of agitation in
patients with Alzheimer’s disease (AD) and other central nervous
system (CNS) indications. The double-blind, placebo-controlled
study will evaluate the safety and tolerability of single ascending
doses of ALKS 7119 in approximately 60 healthy subjects. ALKS 7119
is a novel small molecule that acts on multiple key receptor
systems in the brain.
“Agitation is a common and debilitating psychiatric symptom of
Alzheimer’s disease that currently has no approved medicines, and
causes significant burden on patients and their caregivers,”
commented Elliot Ehrich, M.D., Chief Medical Officer of Alkermes.
“We believe that the multivalent mechanism of ALKS 7119 has
promising potential to treat agitation associated with Alzheimer’s
disease and other important psychiatric indications. With the
successful completion of a thorough preclinical development phase,
we are excited to launch our clinical program and look forward to
seeing the results from this phase 1 study later this year.”
The randomized, double-blind, placebo-controlled, multi-cohort,
phase 1 study will investigate the safety and tolerability of
single ascending doses of ALKS 7119 following oral administration
in approximately 60 healthy male adults. The study will also
include a battery of psychometric assessments, which are intended
to provide preliminary insight into the potential human
pharmacodynamic response. Results from this phase 1 study are
expected in the second half of 2016.
About ALKS 7119ALKS 7119 is
a novel chemical entity 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
DiseaseAlzheimer’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 AlkermesAlkermes 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
StatementsCertain 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 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, Alkermes may not
be permitted by regulatory authorities to undertake new or
additional clinical studies for ALKS 7119; 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.
1 National Institute on Aging. About Alzheimer's Disease:
Alzheimer's Basics. Accessed from
https://www.nia.nih.gov/alzheimers/topics/alzheimers-basics on Jan.
22, 2016.2 Wadsworth LP et al. Neuropsychiatric Symptoms and Global
Functional Impairment along the Alzheimer’s Continuum. Dement
Geriatr Cogn Disord. 2012; 34:96-111.3 Alzheimer’s Association.
Alzheimer’s Facts and Figures. Accessed from
http://www.alz.org/alzheimers_disease_facts_and_figures.asp#quickFacts
on Jan. 22, 2016.
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AlkermesFor Investors:Eva
Stroynowski, +1 781-609-6823orFor Media:Jennifer Snyder, +1
781-609-6166
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