Pimavanserin Misses Primary Endpoint of Antipsychotic Efficacy; Meets
Key Secondary Endpoint of Motoric Tolerability
Conference Call Scheduled for Today, September 1, at 8:00 A.M.
Eastern Time
SAN DIEGO--(BUSINESS WIRE)--Sep. 1, 2009--
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD) today announced top-line
results from the first pivotal Phase III trial with pimavanserin in
patients with Parkinson’s disease psychosis, or PDP. The study did not
meet its primary endpoint of antipsychotic efficacy as measured using
the Scale for the Assessment of Positive Symptoms, or SAPS. Pimavanserin
met the key secondary endpoint of motoric tolerability as measured using
the Unified Parkinson’s Disease Rating Scale, or UPDRS. Pimavanserin was
safe and well tolerated, with the frequency of adverse events generally
similar in the pimavanserin and placebo arms.
The primary endpoint of the study was the mean change in SAPS scores at
day 42 compared to baseline for each of the two pimavanserin treatment
arms versus placebo. Patients showed marked improvements in the SAPS
scores across all study arms. Mean reductions in SAPS scores were 5.9
points in the placebo arm, 5.8 points in the 10 mg pimavanserin arm, and
6.7 points in the 40 mg pimavanserin arm. Statistical significance was
not achieved in either pimavanserin arm primarily due to the larger than
expected improvement in placebo-treated patients.
“While we obviously are disappointed with the results of this Phase III
study, we continue to believe in the potential of pimavanserin based on
our clinical experience to date,” said Uli Hacksell, Ph.D., Chief
Executive Officer of ACADIA. “We will thoroughly analyze these data
along with the data on other secondary and exploratory endpoints over
the next month to better understand the outcome of this study.
Meanwhile, we are continuing with the second Phase III PDP trial with
pimavanserin.”
Trial Design
The Phase III trial was a multi-center, double-blind, placebo-controlled
study designed to evaluate the safety and efficacy of pimavanserin in
patients with PDP. A total of 298 patients were enrolled in the trial
and randomized to one of three study arms, including two different doses
of pimavanserin (10 mg or 40 mg) and placebo. Patients received oral
doses of either pimavanserin or placebo once daily for six weeks.
Patients remained on stable doses of their existing anti-Parkinson’s
therapy throughout the study. The primary endpoint was antipsychotic
efficacy as measured using the hallucinations and delusions domains of
the SAPS. The key secondary endpoint was motoric tolerability as
measured using Parts II and III of the UPDRS.
About Pimavanserin
Pimavanserin is a 5-HT2A receptor inverse agonist in Phase
III development as a treatment for Parkinson’s disease psychosis. This
new chemical entity, which was discovered by ACADIA, is a small molecule
that can be taken orally as a tablet once-a-day. ACADIA and Biovail have
formed a collaboration to co-develop and commercialize pimavanserin for
neurological and psychiatric indications, including Parkinson’s disease
psychosis (PDP) and Alzheimer’s disease psychosis (ADP), in the United
States and Canada. ACADIA retains rights to pimavanserin in the rest of
the world.
About Parkinson’s Disease Psychosis
According to the National Parkinson Foundation, over 1.5 million people
in the United States suffer from Parkinson’s disease. Up to 40 percent
of patients with Parkinson’s disease may develop psychotic symptoms,
commonly consisting of visual hallucinations and delusions. Currently
there is no therapy in the United States approved to treat PDP. The
development of psychosis in patients with Parkinson’s disease is
associated with increased caregiver burden, nursing home placement, and
increased mortality.
Conference Call and Webcast Information
ACADIA will host a conference call and webcast today, September 1, 2009,
at 8:00 a.m. Eastern Time to discuss the top-line results from the
first pivotal Phase III trial with pimavanserin in patients with PDP.
The conference call can be accessed by dialing 866-713-8564 for
participants in the U.S. or Canada and 617-597-5312 for international
callers (reference passcode 15968327). A telephone replay of the
conference call may be accessed through September 15, 2009 by dialing
888-286-8010 for callers in the U.S. or Canada and 617-801-6888 for
international callers (reference passcode 88296469). The conference call
also will be webcast live on ACADIA’s website, www.acadia-pharm.com,
under the investors section and will be archived there until September
15.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company utilizing innovative technology to
fuel drug discovery and clinical development of novel treatments for
central nervous system disorders. ACADIA’s product candidates include
pimavanserin in Phase III for Parkinson’s disease psychosis in
collaboration with Biovail, a product candidate in Phase II for chronic
pain and a product candidate in Phase I for glaucoma, both in
collaboration with Allergan, as well as additional compounds in
IND-track development. All of the product candidates in ACADIA’s
pipeline emanate from discoveries made using its proprietary drug
discovery platform. 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 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 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, commercialization
and collaborations with others, and the fact that past results of
clinical trials may not be indicative of further 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, 2008 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.
Investor Contacts:
ACADIA Pharmaceuticals Inc.
Lisa
Barthelemy, Director, Investor Relations
Uli Hacksell,
Ph.D., Chief Executive Officer
(858) 558-2871
or
Media
Contact:
Russo Partners
David Schull, President
(212)
845-4271
