ACADIA Announces Presentation of Data from Its Pivotal Phase III Parkinson’s Disease Psychosis Study with Pimavanserin at the

  ACADIA Announces Presentation of Data from Its Pivotal Phase III Parkinson’s
  Disease Psychosis Study with Pimavanserin at the American Academy of
  Neurology Annual Meeting

Business Wire

SAN DIEGO -- March 21, 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, announced that
Jeffrey Cummings, M.D., Sc.D., Director of Cleveland Clinic Lou Ruvo Center
for Brain Health, presented detailed results today from ACADIA’s pivotal Phase
III -020 Study with pimavanserin in patients with Parkinson’s disease
psychosis at the Emerging Science session of the 65^th American Academy of
Neurology (AAN) Annual Meeting. The analysis of the full data set from the
Phase III -020 Study showed robust and consistent efficacy of pimavanserin
across a wide array of study measures and confirmed the positive top-line
results previously reported.

Pimavanserin met the primary endpoint in the -020 Study by demonstrating
highly significant antipsychotic efficacy on the 9-item SAPS-PD scale
(p=0.001). Pimavanserin also met the key secondary endpoint for motoric
tolerability as measured using Parts II and III of the Unified Parkinson’s
Disease Rating Scale, or UPDRS. Dr. Cummings presented new data from the -020
Study showing highly significant improvements in all secondary efficacy
measures, including the Clinical Global Impression Severity, or CGI-S, scale
(p<0.001), the Clinical Global Impression Improvement, or CGI-I, scale
(p=0.001), and a CGI-I responder analyses (p=0.002). The CGI-I responder
results showed that approximately twice as many subjects in the pimavanserin
treatment arm, as compared to placebo, were rated as very much improved or
much improved at the conclusion of the study. In addition, pimavanserin
demonstrated significant improvements using the full 20-item SAPS scale and
each of the separate hallucinations and delusions domains in supportive
analyses. Statistically significant benefits were also observed in exploratory
measures of nighttime sleep, daytime wakefulness, and caregiver burden.

“The significant and consistent results observed across measures in the Phase
III -020 Study are impressive and potentially very encouraging for Parkinson’s
patients who suffer from the psychosis frequently associated with this
disease,” said Dr. Jeffrey Cummings. “Importantly, regardless of whether
assessments were performed by independent blinded raters, site investigators
or caregivers, clear benefits were observed and clinical measures were well
aligned. The results of this study suggest that a selective,
non-dopaminergic-based therapy has the potential to transform the standard of
care by providing an effective, safe and well tolerated treatment for patients
suffering from this large unmet medical need.”

Safety and Tolerability Profile

Consistent with previous studies, pimavanserin was safe and well tolerated in
the -020 Study. The most common adverse events were urinary tract infection
(11.7% PBO vs. 13.5% PIM) and falls (8.5% PBO vs. 10.6% PIM). Adverse events
were generally characterized as mild to moderate in nature. The only serious
adverse events that occurred in more than one patient were urinary tract
infection (1-PBO vs. 3-PIM) and psychotic disorder (0-PBO vs. 2-PIM). Over
ninety percent of the patients who completed the clinical phase of this trial
elected to roll over into the ongoing open-label safety extension study.
Patients were only eligible to participate in the extension study if the
treating investigator also deemed them to be likely to benefit from continued
treatment with pimavanserin.

About the Trial Design

The pivotal Phase III trial, referred to as the -020 Study, was a
multi-center, double-blind, placebo-controlled study designed to evaluate the
efficacy, tolerability and safety of pimavanserin as a treatment for patients
with Parkinson’s disease psychosis. A total of 199 patients were enrolled in
the study and randomized on a one-to-one basis to receive either 40 mg of
pimavanserin or placebo once-daily for six weeks, following a two-week
screening period including brief psycho-social therapy. Patients also received
stable doses of their existing anti-Parkinson’s therapy throughout the study.
The primary endpoint of the -020 Study was antipsychotic efficacy as measured
using the “SAPS–PD” scale, which consists of nine items from the
hallucinations and delusions domains of the Scale for the Assessment of
Positive Symptoms, or SAPS. These nine items have been shown to be
particularly relevant to the expression of psychotic symptoms in patients with
Parkinson’s disease and to have high inter-rater reliability for assessment of
severity. Motoric tolerability was a key secondary endpoint in the study and
was measured using Parts II and III of the Unified Parkinson’s Disease Rating
Scale, or UPDRS.

About Pimavanserin

Pimavanserin is ACADIA’s proprietary small molecule that acts selectively as
an antagonist/inverse agonist on serotonin 5-HT[2A] receptors and is in Phase
III development as a potential first-in-class treatment for Parkinson’s
disease psychosis. Pimavanserin can be taken orally as a tablet once-a-day.
ACADIA discovered pimavanserin and holds worldwide rights to this new chemical
entity.

About Parkinson’s Disease Psychosis

According to the National Parkinson’s Foundation, about one million people in
the United States and from four to six million people worldwide suffer from
Parkinson’s disease. Parkinson’s disease psychosis, or PDP, is a debilitating
disorder that develops in up to 60 percent of patients with Parkinson’s
disease. Currently, there is no FDA-approved therapy to treat PDP in the
United States. PDP, commonly consisting of visual hallucinations and
delusions, substantially contributes to the burden of Parkinson’s disease and
deeply affects the quality of life of patients. PDP is associated with
increased caregiver stress and burden, nursing home placement, and increased
morbidity and mortality. There is a large unmet medical need for new therapies
that will effectively treat PDP without compromising motor control in patients
with Parkinson’s disease.

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 email alerts.

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, either alone or with a partner, including clinical
trials, the benefits to be derived from ACADIA’s product candidates, in each
case including pimavanserin, the potential benefit of pimavanserin to PDP
sufferers, and the potential of a selective, non-dopaminergic-based therapy to
transform the standard of care for PDP patients by providing an effective,
safe and well-tolerated treatment. 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
858-558-2871
 
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