Alkermes Announces Plan to Initiate Second Clinical Trial of ALKS 7119 Based on Preliminary Phase 1 Results
April 28 2016 - 6:58AM
Business Wire
— 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 —
Alkermes plc (NASDAQ: ALKS) today announced preliminary findings
from a phase 1 clinical trial of ALKS 7119, an oral, novel small
molecule that acts on multiple key receptor systems in the brain.
ALKS 7119 is being developed for the treatment of agitation in
patients with Alzheimer’s disease and other central nervous system
(CNS) indications. Based on initial blinded data from the ongoing
single-ascending-dose study, Alkermes has accelerated the decision
to advance ALKS 7119 into a multiple-ascending-dose phase 1 study.
The study is planned to commence in the third quarter of 2016 and
results are expected around year-end.
Initiated in January 2016, the double-blind, placebo-controlled
single-ascending-dose study was designed to evaluate the safety and
tolerability, as well as the pharmacokinetic properties of ALKS
7119 in healthy volunteers. Preliminary data from the first six
escalating dose cohorts demonstrated a favorable tolerability
profile for ALKS 7119 and pharmacokinetic properties consistent
with potential once-daily dosing. Full results from the ongoing
single-ascending-dose phase 1 study, including unblinded safety
data, are expected in the second half of 2016.
“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 Elliot Ehrich, M.D., Chief
Medical Officer of Alkermes. “ALKS 7119’s multivalent mechanism has
promising potential to address the significant unmet needs of
patients and caregivers by treating the debilitating condition of
agitation associated with Alzheimer’s disease.”
About ALKS 7119ALKS 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
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 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, 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 Annual
Report on Form 10-K for the fiscal year ended Dec. 31, 2015, 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
April 27, 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.
3Alzheimer’s Association. Alzheimer’s Facts and Figures.
Accessed from
http://www.alz.org/alzheimers_disease_facts_and_figures.asp#quickFacts
on April 27, 2016.
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AlkermesFor Investors:Sandy Coombs, +1-781-609-6377orFor
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