"The start of the first Phase III pivotal trial in ourpimavanserin PDP program is a key milestone for ACADIA and animportant step forward toward our goal of providing a first-in-classtreatment for patients with PDP," said Uli Hacksell, Ph.D., ChiefExecutive Officer of ACADIA Pharmaceuticals. "There currently is nodrug approved by the U.S. Food and Drug Administration for thetreatment of PDP. We believe pimavanserin may provide a uniquecombination of antipsychotic efficacy, motoric tolerability and safetyand, therefore, represents an important advance in therapy forpatients suffering from this debilitating disorder."
The Phase III trial is a multi-center, double-blind,placebo-controlled study designed to evaluate the safety and efficacyof pimavanserin in approximately 240 patients with PDP. Patients inthe trial will be randomized to three different study arms, which willinclude two different doses of pimavanserin (10 mg and 40 mg) and oneplacebo arm. Patients will receive oral doses of either pimavanserinor placebo once daily for six weeks in addition to stable doses oftheir existing dopamine replacement therapy. The primary endpoint ofthe trial is antipsychotic efficacy as measured by the Scale for theAssessment of Positive Symptoms, or SAPS. Motoric tolerability will bean important secondary endpoint in the trial and will be measuredusing the Uniform Parkinson's Disease Rating Scale, or UPDRS.
Additionally, ACADIA intends to provide patients who havecompleted the Phase III trial with the opportunity to enroll in anopen-label safety extension study if, in the opinion of the physician,the patient may benefit from continued treatment with pimavanserin.
About Pimavanserin
Pimavanserin tartrate, previously referred to as ACP-103, is anovel, potent, and selective 5-HT2A inverse agonist that ACADIAdiscovered and is developing as a treatment for PDP. In 2006, ACADIAcompleted a Phase II clinical trial in which pimavanserin demonstratedantipsychotic effects, was safe and well tolerated, and did not impairdisease-related motor function in patients with PDP. ACADIA is alsodeveloping pimavanserin as a co-therapy for schizophrenia and as atreatment for sleep maintenance insomnia.
About Parkinson's Disease Psychosis (PDP)
Parkinson's disease is a chronic neurological disorder thatresults from the degeneration of neurons in a region of the brain thatcontrols movement. According to the American Parkinson's DiseaseAssociation, over 1.5 million people in the United States suffer fromthis disease. Studies have suggested that up to 40 percent of patientswith Parkinson's disease will develop psychotic symptoms, commonlyconsisting of visual hallucinations and delusions. The development ofpsychosis in patients with Parkinson's disease often disrupts theirability to perform many of the activities of living that keep themindependent and active. As a result, Parkinson's disease psychosis isthe most common factor leading to nursing home placements in patientswith Parkinson's disease.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company utilizing innovativetechnology to fuel drug discovery and clinical development of noveltreatments for central nervous system disorders. ACADIA currently hasfive mid-to-late stage clinical programs as well as a portfolio ofpreclinical and discovery assets, directed at diseases with largeunmet medical needs, including schizophrenia, Parkinson's diseasepsychosis, sleep maintenance insomnia, and neuropathic pain. All ofthe drug candidates in ACADIA's product pipeline emanate fromdiscoveries made using its proprietary drug discovery platform.ACADIA's corporate headquarters is located in San Diego, California,and it maintains research and development operations in both San Diegoand Malmo, Sweden.
Forward-Looking Statements
Statements in this press release that are not strictly historicalin nature are forward-looking statements. These statements include butare not limited to statements related to the progress of ACADIA's drugdiscovery and development programs and the benefits to be derived fromACADIA's drug 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 andcommercialization, and the fact that past results of clinical trialsmay not be indicative of future trial results. For a discussion ofthese and other factors, please refer to ACADIA's annual report onForm 10-K for the year ended December 31, 2006 as well as ACADIA'ssubsequent filings with the Securities and Exchange Commission. Youare cautioned not to place undue reliance on these forward-lookingstatements, which speak only as of the date hereof. This caution ismade under the safe harbor provisions of the Private SecuritiesLitigation Reform Act of 1995. All forward-looking statements arequalified in their entirety by this cautionary statement and ACADIAundertakes no obligation to revise or update this press release toreflect events or circumstances after the date hereof.
SOURCE: ACADIA Pharmaceuticals Inc.
ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director, Investor Relations
Thomas H. Aasen, Vice President andChief Financial Officer
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