SAN DIEGO, Jul 29, 2010 (BUSINESS WIRE) —
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical companyutilizing innovative technology to fuel drug discovery and clinicaldevelopment of novel treatments for central nervous system disorders,today announced that it has initiated a new Phase III trial designed toevaluate the efficacy, tolerability and safety of pimavanserin as atreatment for patients with Parkinson's disease psychosis (PDP).
"This Phase III trial builds on the signals of efficacy observed in ourearlier PDP studies and uses a refined study design that we expect willhelp mitigate the placebo response, reduce variability and enhancesensitivity in measuring the efficacy of pimavanserin in PDP patients,"said Uli Hacksell, Ph.D., Chief Executive Officer of ACADIAPharmaceuticals. "We believe pimavanserin has an ideal profile toeffectively treat PDP without impairing motor function and, therefore,provides the potential for an important advance in therapy for patientssuffering from this large unmet medical need."
Trial Design
The new Phase III trial (the -020 Study) is a multi-center,double-blind, placebo-controlled study designed to evaluate theefficacy, tolerability and safety of pimavanserin in patients with PDP.The -020 Study is expected to enroll about 200 patients at clinicalsites located in North America. Patients in the trial will be randomizedon a one-to-one basis to two study arms and will receive oral doses ofeither 40 mg of pimavanserin or placebo once-daily for six weeks.Patients also will continue to receive stable doses of their existingdopamine replacement therapy used to manage the motoric symptoms ofParkinson's disease. The primary endpoint of the -020 Study isantipsychotic efficacy as measured using a group of nine items from thehallucinations and delusions domains of the Scale for the Assessment ofPositive Symptoms (SAPS). The primary endpoint will be assessed usingcentralized ratings. Motoric tolerability will be a key secondaryendpoint in the trial and will be measured using Parts II and III of theUnified Parkinson's Disease Rating Scale (UPDRS).
In addition to the -020 Study, ACADIA is continuing to conduct anopen-label safety extension study (the -015 Study) that enrolledpatients who completed either of two earlier Phase III PDP trials.Patients who complete the -020 Study also will have the opportunity toenroll in the -015 Study if, in the opinion of the treating physician,the patient may benefit from continued treatment with pimavanserin.
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 BiovailLaboratories International SRL (Biovail), a subsidiary of BiovailCorporation, have formed a collaboration to develop and commercializepimavanserin for neurological and psychiatric indications, includingParkinson's disease psychosis, schizophrenia, and Alzheimer's diseasepsychosis, in the United States and Canada. ACADIA retains rights topimavanserin in the rest of the world.
About Parkinson's Disease Psychosis
According to the National Parkinson Foundation, over 1.5 million peoplein the United States suffer from Parkinson's disease. Up to 40 percentof 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. Thedevelopment of psychosis in patients with Parkinson's disease oftendisrupts their ability to perform many of the activities of daily livingand is associated with increased caregiver burden, nursing homeplacement, and increased mortality.
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 is developing a portfolioconsisting of four product candidates including pimavanserin, which isbeing developed for three separate neurological and psychiatricindications in collaboration with Biovail. These indications areParkinson's disease psychosis, which is in Phase III development,co-therapy for schizophrenia, which is in Phase III planning, andAlzheimer's disease psychosis, for which ACADIA is planning to initiatea Phase II feasibility study. In addition to pimavanserin, ACADIA has aproduct candidate in Phase II for chronic pain and a product candidatein Phase I for glaucoma, both in collaboration with Allergan, as well asa product candidate in IND-track development for schizophrenia incollaboration with Meiji Seika Kaisha. All of the product candidates inACADIA's product pipeline emanate from discoveries made using itsproprietary drug discovery platform. ACADIA maintains a website at www.acadia-pharm.comto which ACADIA regularly posts copies of its press releases as well asadditional information and through which interested parties cansubscribe to receive e-mail alerts.
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 design, progress and timing ofACADIA's drug discovery and development programs, including the -020Study and ACADIA's other clinical trials and the results therefrom, andthe potential of and the benefits to be derived from clinical trials andproduct candidates, including pimavanserin. These statements are onlypredictions based on current information and expectations and involve anumber of risks and uncertainties. Actual events or results may differmaterially from those projected in any of such statements due to variousfactors, including the risks and uncertainties inherent in drugdiscovery, development and commercialization and collaborations withothers, and the fact that past results of clinical trials may not beindicative of future trial results. For a discussion of these and otherfactors, please refer to ACADIA's annual report on Form 10-K for theyear ended December 31, 2009 as well as ACADIA's subsequent filings withthe Securities and Exchange Commission. You are cautioned not to placeundue reliance on these forward-looking statements, which speak only asof the date hereof. This caution is made under the safe harborprovisions of the Private Securities Litigation Reform Act of 1995. Allforward-looking statements are qualified in their entirety by thiscautionary statement and ACADIA undertakes no obligation to revise orupdate this press release to reflect events or circumstances after thedate hereof, except as required by law.
SOURCE: ACADIA Pharmaceuticals Inc.
ACADIA Pharmaceuticals Inc.
Uli Hacksell, Ph.D., Chief Executive Officer
(858) 558-2871