Pimavanserin Misses Primary Endpoint of Antipsychotic Efficacy; MeetsKey Secondary Endpoint of Motoric Tolerability
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The primary endpoint of the study was the mean change in SAPS scores atday 42 compared to baseline for each of the two pimavanserin treatmentarms versus placebo. Patients showed marked improvements in the SAPSscores across all study arms. Mean reductions in SAPS scores were 5.9points in the placebo arm, 5.8 points in the 10 mg pimavanserin arm, and6.7 points in the 40 mg pimavanserin arm. Statistical significance wasnot achieved in either pimavanserin arm primarily due to the larger thanexpected improvement in placebo-treated patients.
“While we obviously are disappointed with the results of this Phase IIIstudy, we continue to believe in the potential of pimavanserin based onour clinical experience to date,” said Uli Hacksell, Ph.D., ChiefExecutive Officer of ACADIA. “We will thoroughly analyze these dataalong with the data on other secondary and exploratory endpoints overthe next month to better understand the outcome of this study.Meanwhile, we are continuing with the second Phase III PDP trial withpimavanserin.”
Trial Design
The Phase III trial was a multi-center, double-blind, placebo-controlledstudy designed to evaluate the safety and efficacy of pimavanserin inpatients with PDP. A total of 298 patients were enrolled in the trialand randomized to one of three study arms, including two different dosesof pimavanserin (10 mg or 40 mg) and placebo. Patients received oraldoses of either pimavanserin or placebo once daily for six weeks.Patients remained on stable doses of their existing anti-Parkinson’stherapy throughout the study. The primary endpoint was antipsychoticefficacy as measured using the hallucinations and delusions domains ofthe SAPS. The key secondary endpoint was motoric tolerability asmeasured using Parts II and III of the UPDRS.
About Pimavanserin
Pimavanserin is a 5-HT2A receptor inverse agonist in PhaseIII development as a treatment for Parkinson’s disease psychosis. Thisnew chemical entity, which was discovered by ACADIA, is a small moleculethat 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 Pharmaceuticals
ACADIA is a biopharmaceutical company utilizing innovative technology tofuel drug discovery and clinical development of novel treatments forcentral nervous system disorders. ACADIA’s product candidates includepimavanserin in Phase III for Parkinson’s disease psychosis incollaboration with
Forward-Looking Statements
Statements in this press release that are not strictly historical innature are forward-looking statements. These statements include but arenot limited to statements related to the progress and timing of drugdiscovery and development programs, including clinical trials and theresults therefrom, and the potential of and the benefits to be derivedfrom product candidates, in each case including pimavanserin. Thesestatements are only predictions based on current information andexpectations and involve a number of risks and uncertainties. Actualevents or results may differ materially from those projected in any ofsuch statements due to various factors, including the risks anduncertainties inherent in drug discovery, development, commercializationand collaborations with others, and the fact that past results ofclinical trials may not be indicative of further trial results. For adiscussion of these and other factors, please refer to ACADIA’s annualreport on Form 10-K for the year ended December 31, 2008 as well asACADIA’s subsequent filings with the
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ACADIA Pharmaceuticals Inc.
LisaBarthelemy, Director, Investor Relations
Uli Hacksell,Ph.D., Chief Executive Officer
(858) 558-2871
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