SAN DIEGO—(BUSINESS WIRE)—Nov. 14, 2013—ACADIA Pharmaceuticals Inc. (NASDAQ:ACAD), a biopharmaceutical companyfocused on innovative treatments that address unmet medical needs inneurological and related central nervous system disorders, todayannounced that it has initiated a Phase II feasibility trial designed toexamine the efficacy and safety of pimavanserin as a treatment forpatients with Alzheimer’s disease psychosis (ADP). No drug is approvedin the United States to treat ADP and the off-label use of currentantipsychotics is linked to increased mortality, serious adverse events,and cognitive decline in elderly patients with dementia-relatedpsychosis.
“The development of psychosis and related behavioral disturbances inpatients with Alzheimer’s disease carries a poor prognosis and often hasa devastating impact on both patients and their caregivers,” said CliveBallard, M.D., Professor of Age Related Diseases at King’s CollegeLondon. “Finding new therapies that can effectively treat ADP withoutcompromising safety is an important priority for the neurology communityand society as a whole. Pimavanserin’s attractive efficacy, tolerabilityand safety profile observed in a Phase III trial in patients withParkinson’s disease psychosis suggests that it may offer the potentialfor an important new therapeutic advance for patients suffering fromADP.”
The Phase II feasibility trial, referred to as the -019 Study, is arandomized, double-blind, placebo-controlled study designed to examinethe efficacy and safety of pimavanserin in about 200 patients with ADP.The study is being conducted through a large network of research carehomes established as part of the National Institute for Health Research(NIHR) Maudsley Biomedical Research Unit. Following a screening periodthat includes brief psycho-social therapy, patients will be randomizedon a one-to-one basis to receive either 40 mg of pimavanserin or placeboonce-daily for 12 weeks. The -019 Study will assess several key efficacyendpoints, including use of the Neuropsychiatric Inventory - NursingHome (NPI-NH) scale to measure psychosis (hallucinations and delusions),agitation/aggression, and sleep/nighttime behavior, as well as use ofthe Cohen-Mansfield Agitation Inventory - Short Form (CMAI-SF) scale andthe Alzheimer’s Disease Cooperative Study - Clinical Global Impressionof Change (ADCS-CGIC) scale. Key efficacy endpoints will be based on thechange at week six from baseline. The study will also assess additionalexploratory endpoints, including the cognitive status of patients usingthe Mini-Mental State Examination (MMSE) scale, and the durability ofresponse to pimavanserin through twelve weeks of therapy.
“We are delighted to pursue this clinical study in collaboration withProfessor Ballard and King’s College London,” said Roger G. Mills, M.D.,ACADIA’s Executive Vice President of Development and Chief MedicalOfficer. “We believe that their unique clinical research infrastructureand expertise will provide access to a pool of well-characterized ADPpatients and enable the use of a small and geographically-focused groupof highly trained raters, which we expect to enhance study precision.”
About Alzheimer’s Disease Psychosis
According to the Alzheimer’s Association, 5.4 million people in theUnited States are living with Alzheimer’s disease. While the criteriafor diagnosing Alzheimer’s disease are mostly focused on cognitivedeficits, it is often the psychiatric and related behavioral symptomsthat are most troublesome for caregivers and lead to poor quality oflife for patients. An estimated 25 to 50 percent of Alzheimer’s patientsmay develop Alzheimer’s disease psychosis (ADP), which is commonlycharacterized by disturbing visual hallucinations and delusions. Thediagnosis of ADP is associated with more rapid cognitive and functionaldecline and institutionalization. There currently is no therapy approvedfor the treatment of ADP in the United States.
About Pimavanserin
Pimavanserin is ACADIA’s proprietary small molecule that actsselectively as an antagonist/inverse agonist on serotonin 5-HT2A receptors.ACADIA has successfully completed a pivotal Phase III trial withpimavanserin, which demonstrated robust efficacy, tolerability andsafety in patients with Parkinson’s disease psychosis (PDP), potentiallypositioning it to be the first drug approved in the United States forthe treatment of this disorder. Pimavanserin is also in Phase IIdevelopment for Alzheimer’s disease psychosis (ADP) and has completed aPhase II trial as a co-therapy in schizophrenia. Pimavanserin isformulated as a tablet and is administered orally once-a-day. ACADIAdiscovered pimavanserin and holds worldwide rights to this new chemicalentity.
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 Allergan, Inc. and two advanced preclinical programsdirected at Parkinson’s disease and other neurological disorders. Allproduct candidates are small molecules that emanate from discoveriesmade at ACADIA. 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.
About NIHR Maudsley Biomedical Research Centre
The National Institute for Health Research (NIHR) Mental HealthBiomedical Research Centre and Dementia Unit (BRC/U) at South London andMaudsley NHS Foundation Trust and Institute of Psychiatry, King'sCollege London aim to turn the latest scientific knowledge in mentalhealth into improved medical treatments for the benefit of all patientsand carers. We are the only BRC/U specialising in mental health research.
We are part of King’s Health Partners Academic Health Sciences Centre, apioneering collaboration between King’s College London, and Guy’s and StThomas’, King’s College Hospital and South London and Maudsley NHSFoundation Trusts (http://brc.slam.nhs.uk/).
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, including clinical trials andthe results therefrom, and the potential of and the benefits to bederived from product candidates, in each case including pimavanserin.These statements also include any suggestion that the results fromtrials with pimavanserin in PDP will be predictive of results in the-019 Study for ADP or whether the use of a geographically-focused groupof raters will enhance precision in the -019 Study. These statements areonly predictions based on current information and expectations andinvolve a number of risks and uncertainties. Actual events or resultsmay differ materially from those projected in any of such statements dueto various factors, including the risks and uncertainties inherent indrug discovery, development and commercialization and collaborationswith others, and the fact that past results of clinical trials may notbe indicative of future trial results. For a discussion of these andother factors, please refer to ACADIA’s annual report on Form 10-K forthe year ended December 31, 2012 as well as ACADIA’s subsequent filingswith the Securities and Exchange Commission. You are cautioned not toplace undue reliance on these forward-looking statements, which speakonly as of 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., ChiefExecutive Officer
Lisa Barthelemy, Director of InvestorRelations
858-558-2871