ACADIA Pharmaceuticals Announces Initiation of Phase II Trial with Pimavanserin for Alzheimer’s Disease Psychosis

  ACADIA Pharmaceuticals Announces Initiation of Phase II Trial with
  Pimavanserin for Alzheimer’s Disease Psychosis

Business Wire

SAN DIEGO -- November 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-HT[2A ]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 December31,
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.

Contact:

ACADIA Pharmaceuticals Inc.
Uli Hacksell, Ph.D., Chief Executive Officer
Lisa Barthelemy, Director of Investor Relations
858-558-2871
 
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