Pimavanserin met the primary endpoint in the -020 Study by demonstratinghighly significant antipsychotic efficacy on the 9-item SAPS-PD scale(p=0.001). Pimavanserin also met the key secondary endpoint for motorictolerability as measured using Parts II and III of the UnifiedParkinson’s Disease Rating Scale, or UPDRS. Dr. Cummings presented newdata from the -020 Study showing highly significant improvements in allsecondary efficacy measures, including the Clinical Global ImpressionSeverity, or CGI-S, scale (p<0.001), the Clinical Global ImpressionImprovement, or CGI-I, scale (p=0.001), and a CGI-I responder analyses(p=0.002). The CGI-I responder results showed that approximately twiceas many subjects in the pimavanserin treatment arm, as compared toplacebo, were rated as very much improved or much improved at theconclusion of the study. In addition, pimavanserin demonstratedsignificant improvements using the full 20-item SAPS scale and each ofthe separate hallucinations and delusions domains in supportiveanalyses. Statistically significant benefits were also observed inexploratory measures of nighttime sleep, daytime wakefulness, andcaregiver burden.
“The significant and consistent results observed across measures in thePhase III -020 Study are impressive and potentially very encouraging forParkinson’s patients who suffer from the psychosis frequently associatedwith this disease,” said Dr.
Safety and Tolerability Profile
Consistent with previous studies, pimavanserin was safe and welltolerated in the -020 Study. The most common adverse events were urinarytract 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 innature. The only serious adverse events that occurred in more than onepatient were urinary tract infection (1-PBO vs. 3-PIM) and psychoticdisorder (0-PBO vs. 2-PIM). Over ninety percent of the patients whocompleted the clinical phase of this trial elected to roll over into theongoing open-label safety extension study. Patients were only eligibleto participate in the extension study if the treating investigator alsodeemed them to be likely to benefit from continued treatment withpimavanserin.
About the Trial Design
The pivotal Phase III trial, referred to as the -020 Study, was amulti-center, double-blind, placebo-controlled study designed toevaluate the efficacy, tolerability and safety of pimavanserin as atreatment for patients with Parkinson’s disease psychosis. A total of199 patients were enrolled in the study and randomized on a one-to-onebasis to receive either 40 mg of pimavanserin or placebo once-daily forsix weeks, following a two-week screening period including briefpsycho-social therapy. Patients also received stable doses of theirexisting anti-Parkinson’s therapy throughout the study. The primaryendpoint of the -020 Study was antipsychotic efficacy as measured usingthe “SAPS–PD” scale, which consists of nine items from thehallucinations and delusions domains of the Scale for the Assessment ofPositive Symptoms, or SAPS. These nine items have been shown to beparticularly relevant to the expression of psychotic symptoms inpatients with Parkinson’s disease and to have high inter-raterreliability for assessment of severity. Motoric tolerability was a keysecondary endpoint in the study and was measured using Parts II and IIIof the Unified Parkinson’s Disease Rating Scale, or UPDRS.
About Pimavanserin
Pimavanserin is ACADIA’s proprietary small molecule that actsselectively as an antagonist/inverse agonist on serotonin 5-HT2Areceptors and is in Phase III development as a potential first-in-classtreatment for Parkinson’s disease psychosis. Pimavanserin can be takenorally as a tablet once-a-day. ACADIA discovered pimavanserin and holdsworldwide rights to this new chemical entity.
About Parkinson’s Disease Psychosis
According to the National Parkinson’s Foundation, about one millionpeople in
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company focused on innovative treatmentsthat address unmet medical needs in neurological and related centralnervous system disorders. ACADIA has a pipeline of product candidatesled by pimavanserin, which is in Phase III development as a potentialfirst-in-class treatment for Parkinson's disease psychosis. ACADIA alsohas clinical-stage programs for chronic pain and glaucoma 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 ACADIA’sdrug discovery and development programs, either alone or with a partner,including clinical trials, the benefits to be derived from ACADIA’sproduct candidates, in each case including pimavanserin, the potentialbenefit of pimavanserin to PDP sufferers, and the potential of aselective, non-dopaminergic-based therapy to transform the standard ofcare for PDP patients by providing an effective, safe and well-toleratedtreatment. These statements are only predictions based on currentinformation and expectations and involve a number of risks anduncertainties. Actual events or results may differ materially from thoseprojected in any of such statements due to various factors, includingthe risks and uncertainties inherent in drug discovery, development andcommercialization, and collaborations with others, and the fact thatpast results of clinical trials may not be indicative of future trialresults. For a discussion of these and other factors, please refer toACADIA’s annual report on Form 10-K for the year ended December 31, 2012as well as ACADIA’s subsequent filings with the
Source:
ACADIA Pharmaceuticals Inc.
Uli Hacksell, Ph.D., ChiefExecutive Officer
858-558-2871