SAN DIEGO--(BUSINESS WIRE)--Nov. 14, 2013--
ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD), a biopharmaceutical company
focused on innovative treatments that address unmet medical needs in
neurological and related central nervous system disorders, today
announced that it has initiated a Phase II feasibility trial designed to
examine the efficacy and safety of pimavanserin as a treatment for
patients with Alzheimer’s disease psychosis (ADP). No drug is approved
in the United States to treat ADP and the off-label use of current
antipsychotics is linked to increased mortality, serious adverse events,
and cognitive decline in elderly patients with dementia-related
psychosis.
“The development of psychosis and related behavioral disturbances in
patients with Alzheimer’s disease carries a poor prognosis and often has
a devastating impact on both patients and their caregivers,” said Clive
Ballard, M.D., Professor of Age Related Diseases at King’s College
London. “Finding new therapies that can effectively treat ADP without
compromising safety is an important priority for the neurology community
and society as a whole. Pimavanserin’s attractive efficacy, tolerability
and safety profile observed in a Phase III trial in patients with
Parkinson’s disease psychosis suggests that it may offer the potential
for an important new therapeutic advance for patients suffering from
ADP.”
The Phase II feasibility trial, referred to as the -019 Study, is a
randomized, double-blind, placebo-controlled study designed to examine
the efficacy and safety of pimavanserin in about 200 patients with ADP.
The study is being conducted through a large network of research care
homes established as part of the National Institute for Health Research
(NIHR) Maudsley Biomedical Research Unit. Following a screening period
that includes brief psycho-social therapy, patients will be randomized
on a one-to-one basis to receive either 40 mg of pimavanserin or placebo
once-daily for 12 weeks. The -019 Study will assess several key efficacy
endpoints, including use of the Neuropsychiatric Inventory - Nursing
Home (NPI-NH) scale to measure psychosis (hallucinations and delusions),
agitation/aggression, and sleep/nighttime behavior, as well as use of
the Cohen-Mansfield Agitation Inventory - Short Form (CMAI-SF) scale and
the Alzheimer’s Disease Cooperative Study - Clinical Global Impression
of Change (ADCS-CGIC) scale. Key efficacy endpoints will be based on the
change at week six from baseline. The study will also assess additional
exploratory endpoints, including the cognitive status of patients using
the Mini-Mental State Examination (MMSE) scale, and the durability of
response to pimavanserin through twelve weeks of therapy.
“We are delighted to pursue this clinical study in collaboration with
Professor Ballard and King’s College London,” said Roger G. Mills, M.D.,
ACADIA’s Executive Vice President of Development and Chief Medical
Officer. “We believe that their unique clinical research infrastructure
and expertise will provide access to a pool of well-characterized ADP
patients and enable the use of a small and geographically-focused group
of highly trained raters, which we expect to enhance study precision.”
About Alzheimer’s Disease Psychosis
According to the Alzheimer’s Association, 5.4 million people in the
United States are living with Alzheimer’s disease. While the criteria
for diagnosing Alzheimer’s disease are mostly focused on cognitive
deficits, it is often the psychiatric and related behavioral symptoms
that are most troublesome for caregivers and lead to poor quality of
life for patients. An estimated 25 to 50 percent of Alzheimer’s patients
may develop Alzheimer’s disease psychosis (ADP), which is commonly
characterized by disturbing visual hallucinations and delusions. The
diagnosis of ADP is associated with more rapid cognitive and functional
decline and institutionalization. There currently is no therapy approved
for the treatment of ADP in the United States.
About Pimavanserin
Pimavanserin is ACADIA’s proprietary small molecule that acts
selectively as an antagonist/inverse agonist on serotonin 5-HT2A receptors.
ACADIA has successfully completed a pivotal Phase III trial with
pimavanserin, which demonstrated robust efficacy, tolerability and
safety in patients with Parkinson’s disease psychosis (PDP), potentially
positioning it to be the first drug approved in the United States for
the treatment of this disorder. Pimavanserin is also in Phase II
development for Alzheimer’s disease psychosis (ADP) and has completed a
Phase II trial as a co-therapy in schizophrenia. Pimavanserin is
formulated as a tablet and is administered orally once-a-day. ACADIA
discovered pimavanserin and holds worldwide rights to this new chemical
entity.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company focused on innovative treatments
that address unmet medical needs in neurological and related central
nervous system disorders. ACADIA has a pipeline of product candidates
led by pimavanserin, which is in Phase III development as a potential
first-in-class treatment for Parkinson’s disease psychosis. ACADIA also
has clinical-stage programs for chronic pain and glaucoma in
collaboration with Allergan, Inc. and two advanced preclinical programs
directed at Parkinson’s disease and other neurological disorders. All
product candidates are small molecules that emanate from discoveries
made at ACADIA. ACADIA maintains a website at www.acadia-pharm.com
to which ACADIA regularly posts copies of its press releases as well as
additional information and through which interested parties can
subscribe to receive e-mail alerts.
About NIHR Maudsley Biomedical Research Centre
The National Institute for Health Research (NIHR) Mental Health
Biomedical Research Centre and Dementia Unit (BRC/U) at South London and
Maudsley NHS Foundation Trust and Institute of Psychiatry, King's
College London aim to turn the latest scientific knowledge in mental
health into improved medical treatments for the benefit of all patients
and carers. We are the only BRC/U specialising in mental health research.
We are part of King’s Health Partners Academic Health Sciences Centre, a
pioneering collaboration between King’s College London, and Guy’s and St
Thomas’, King’s College Hospital and South London and Maudsley NHS
Foundation Trusts (http://brc.slam.nhs.uk/).
Forward-Looking Statements
Statements in this press release that are not strictly historical in
nature are forward-looking statements. These statements include but are
not limited to statements related to the progress and timing of ACADIA’s
drug discovery and development programs, including clinical trials and
the results therefrom, and the potential of and the benefits to be
derived from product candidates, in each case including pimavanserin.
These statements also include any suggestion that the results from
trials with pimavanserin in PDP will be predictive of results in the
-019 Study for ADP or whether the use of a geographically-focused group
of raters will enhance precision in the -019 Study. These statements are
only predictions based on current information and expectations and
involve a number of risks and uncertainties. Actual events or results
may differ materially from those projected in any of such statements due
to various factors, including the risks and uncertainties inherent in
drug discovery, development and commercialization and collaborations
with others, and the fact that past results of clinical trials may not
be indicative of future trial results. For a discussion of these and
other factors, please refer to ACADIA’s annual report on Form 10-K for
the year ended December 31, 2012 as well as ACADIA’s subsequent filings
with the Securities and Exchange Commission. You are cautioned not to
place undue reliance on these forward-looking statements, which speak
only as of the date hereof. This caution is made under the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. All
forward-looking statements are qualified in their entirety by this
cautionary statement and ACADIA undertakes no obligation to revise or
update this press release to reflect events or circumstances after the
date hereof, except as required by law.
Source: ACADIA Pharmaceuticals Inc.
ACADIA Pharmaceuticals Inc.
Uli Hacksell, Ph.D., Chief
Executive Officer
Lisa Barthelemy, Director of Investor
Relations
858-558-2871