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

Wed Mar 20, 2013 10:00pm EDT

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SAN DIEGO--(Business Wire)--
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 65th 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-HT2A 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 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.

ACADIA Pharmaceuticals Inc.
Uli Hacksell, Ph.D., Chief Executive Officer
858-558-2871



Copyright Business Wire 2013

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