Data from Integrated Analysis of Two Phase III Studies Show Robustand Consistent Efficacy of NUPLAZID Across a Wide Array of Study Measures
Data from Two Open-Label Studies Demonstrate Attractive Safety andTolerability Profile and Potential for Long-Term Effectiveness ofNUPLAZID in Parkinson’s Disease Psychosis
SAN DIEGO—(BUSINESS WIRE)—Jun. 16, 2015—ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical companyfocused on innovative treatments that address unmet medical needs inneurological and related central nervous system disorders, todayannounced the presentation of integrated efficacy and tolerability datafrom its Phase III program with NUPLAZID™ (pimavanserin) at the 19thInternational Congress of Parkinson’s Disease and Movement Disordersheld in San Diego.
“Data from the integrated analysis of Phase III studies continue tosupport the potential for NUPLAZID to safely and effectively treatParkinson’s disease psychosis, a condition for which there is noapproved therapy in the United States,” said Roger Mills, M.D.,Executive Vice President, Development and Chief Medical Officer.“Furthermore, data from our open-label safety extension studies indicatethat long-term administration of NUPLAZID is generally safe and welltolerated in patients with Parkinson’s disease psychosis and thatduration of antipsychotic effect may be maintained for longer than thesix weeks investigated in our Phase III placebo-controlled efficacystudies.”
Poster Presentations
Efficacy and Tolerability of NUPLAZID™ (pimavanserin) in PDPsychosis: Analysis of an Integrated Phase 3 Placebo-Controlled Dataset(Abstract #156)
An integrated analysis was performed on efficacy and tolerability datafrom two six-week Phase III placebo-controlled clinical trials withNUPLAZID (40 mg) in Parkinson’s disease psychosis (PDP). In this largepooled sample of 268 patients from North America, NUPLAZID showed highlysignificant improvement in psychosis compared to placebo on the 9-itemSAPS-PD scale (p<0.001). NUPLAZID demonstrated significant improvementon each of the separate hallucinations and delusions domains and also onsecondary psychoses measures, including the Clinical GlobalImpression-Improvement (CGI-I) and the Clinical GlobalImpression-Severity (CGI-S) scales. In addition, NUPLAZID demonstratedsignificant improvement on nighttime sleep, daytime wakefulness andcaregiver burden, representing additional potential clinically impactfulbenefits. Results were consistent across all subgroups of interest,showing greater improvement with NUPLAZID over placebo regardless ofage, sex, race group or MMSE screening score.
Pooled analysis of data from all Phase III placebo-controlled clinicaltrials with NUPLAZID showed that NUPLAZID was well tolerated and had noimpairment on motor function. The adverse event profile of NUPLAZID wassimilar to placebo.
Long-Term Effectiveness of NUPLAZID™ (pimavanserin) in PD Psychosis:Data from 2 Open-Label Studies (Abstract #149)
Data from two open-label safety extension studies were presented,including final data from a completed Phase II open-label study (-010Study) of 39 PDP patients and interim data from an ongoing Phase IIIopen-label study (-015 Study) of 459 PDP patients. The interim analysisof the ongoing -015 Study reflects data entered into the database as ofDecember 13, 2013. PDP patients in the -015 Study rolled in aftercompleting 6 weeks of blinded treatment in a Phase IIIplacebo-controlled efficacy, tolerability and safety trial. PDP patientsin the -010 Study rolled in following completion of the 4-week treatmentperiod in a Phase II placebo-controlled efficacy, tolerability andsafety trial. In both open-label studies, patients remained on treatmentfor a median duration of over 15 months.
Data from the two open-label studies suggest that long-termadministration of NUPLAZID is generally safe and well tolerated inpatients with PDP. Although there are no formal efficacy endpoints inthe open-label studies, persistent antipsychotic benefit has beenobserved in one or both studies across measures including SAPS-PD, otherSAPS-based outcomes, CGI-I and CGI-S. In the -015 Study, patients whorolled in from a placebo arm showed a highly significant improvement inSAPS-PD and CGI-S scores at Week 4 compared to their score at the end ofthe 6-week randomized study. This improvement was observed for thecombined U.S. and rest-of-world patients. Persistent benefit oncaregiver burden with NUPLAZID has also been observed.
About NUPLAZID™ (pimavanserin)
NUPLAZID is ACADIA’s proprietary small molecule that is a selectiveserotonin inverse agonist preferentially targeting 5-HT2A receptorsthat play an important role in psychosis. ACADIA has reported positivePhase III trial results with NUPLAZID, which has the potential to be thefirst drug approved in the United States for psychosis associated withParkinson’s disease. NUPLAZID is administered orally once-a-day. ACADIAdiscovered NUPLAZID and holds worldwide rights to this new chemicalentity. The trade name NUPLAZID has been provisionally accepted by theFDA.
About Parkinson’s Disease Psychosis
According to the National Parkinson Foundation, about one million peoplein the United States and from four to six million people worldwidesuffer from Parkinson’s disease. Parkinson’s disease psychosis (PDP) isa debilitating disorder that occurs in an estimated 40 percent ofParkinson’s patients. Currently, there is no FDA-approved therapy totreat PDP in the United States. PDP, which commonly consists of visualhallucinations and delusions, substantially contributes to the burden ofParkinson’s disease and deeply affects the quality of life of patients.PDP also is associated with increased caregiver stress and burden,nursing home placement, and increased morbidity and mortality. There isa large unmet medical need for new therapies that will effectively treatPDP without compromising motor control in patients with Parkinson’sdisease.
About ACADIA
ACADIA is a biopharmaceutical company focused on the development andcommercialization of innovative medicines to address unmet medical needsin neurological and related central nervous system disorders. ACADIA hasa pipeline of product candidates led by NUPLAZID™ (pimavanserin), forwhich we have reported positive Phase III trial results in Parkinson’sdisease psychosis and which has the potential to be the first drugapproved in the United States for this disorder. Pimavanserin is also inPhase II development for Alzheimer’s disease psychosis and hassuccessfully completed a Phase II trial in schizophrenia. ACADIA alsohas clinical-stage programs for chronic pain and glaucoma incollaboration with Allergan, Inc. All product candidates are smallmolecules that emanate from internal discoveries. ACADIA maintains awebsite at www.acadia-pharm.comto which we regularly post copies of our 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 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 NUPLAZID (pimavanserin), thepotential for NUPLAZID to be the first drug approved in the UnitedStates for Parkinson’s disease psychosis (PDP), the potential forNUPLAZID to safely and effectively treat PDP, and the potential forNUPLAZID to be effective for long-term treatment of PDP, includingbeyond the 6-week treatment period of prior placebo-controlled clinicaltrials. 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,approval and commercialization, and collaborations with others, and thefact that past results of clinical trials may not be indicative offuture trial results. For a discussion of these and other factors,please refer to ACADIA’s annual report on Form 10-K for the year endedDecember 31, 2014 as well as ACADIA’s subsequent filings with theSecurities and Exchange Commission. You are cautioned not to place unduereliance on these forward-looking statements, which speak only as of thedate hereof. This caution is made under the safe harbor provisions ofthe 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.
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