Pimavanserin Misses Primary Endpoint of Antipsychotic Efficacy; Meets Key Secondary Endpoint of Motoric Tolerability
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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
About Parkinson’s Disease Psychosis
According to the
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About
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
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
Source:
Investor Contacts:
ACADIA Pharmaceuticals Inc.
Lisa
Barthelemy, Director, Investor Relations
Uli Hacksell,
Ph.D., Chief Executive Officer
(858) 558-2871
or
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