Data Support Moving Forward With Further
Development in Alzheimer’s Disease Psychosis
Conference Call and Webcast to Be Held
Today, December 20, 2016, at 8:30 a.m. Eastern Time
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) today announced
positive top-line results from its Phase II exploratory study (-019
Study) of pimavanserin in patients with Alzheimer’s disease
psychosis (AD Psychosis). As a selective serotonin inverse agonist
(SSIA) preferentially targeting 5-HT2A receptors, pimavanserin has
a different biological mechanism than other marketed
antipsychotics. Pimavanserin has been approved by the United States
Food and Drug Administration (FDA) for hallucinations and delusions
associated with Parkinson’s disease psychosis and currently is
being studied in several other disease states, including AD
Psychosis. The FDA has not approved any drug to treat AD
Psychosis.
In this Phase II exploratory study, pimavanserin met the primary
endpoint showing a statistically significant reduction in psychosis
versus placebo as measured by the Neuropsychiatric
Inventory-Nursing Home (NPI-NH) Psychosis score at week 6 of dosing
(p=0.0451). Pimavanserin was generally well tolerated and the
safety profile was consistent with what has been observed in
previous studies.
“Alzheimer’s disease patients suffer from a number of
debilitating symptoms, of which psychosis carries a poor prognosis
and is associated with earlier placement into nursing homes,” said
Steve Davis, ACADIA’s President and Chief Executive Officer. “Data
from the -019 Study provide solid evidence that pimavanserin can
improve psychosis in another major neurological disorder and
provide strategic momentum for the further development of
pimavanserin to address the needs of AD Psychosis patients.”
About the Phase II -019 StudyThe Phase II -019 Study was a
double-blind, placebo-controlled exploratory trial designed to
evaluate the efficacy and safety of pimavanserin as a treatment for
patients with AD Psychosis. A total of 181 patients were enrolled
in the study in the United Kingdom and randomized on a one-to-one
basis to receive either 34 mg of pimavanserin or placebo once
daily. The primary endpoint of the study was antipsychotic efficacy
as measured by the mean change in the NPI-NH Psychosis score
(combined hallucinations and delusions domains) from baseline to
week 6 of dosing. Patients continued dosing through week 12 to
gather information on secondary endpoints, including changes in
cognition.
Pimavanserin demonstrated efficacy on the primary endpoint of
the -019 Study with a 3.76 point improvement in psychosis at week 6
compared to a 1.93 point improvement for placebo, representing a
statistically significant treatment improvement in the NPI-NH
Psychosis score (p=0.0451). Baseline mean scores for the
pimavanserin and placebo treated groups were 9.52 and 10.00,
respectively.
Atypical antipsychotics have been associated with a
statistically significant worsening of cognitive function in
patients with Alzheimer’s disease. In the -019 Study, over the
course of 12 weeks of treatment, pimavanserin did not impair
cognition as measured by the Mini-Mental State Examination (MMSE)
score and was similar to placebo. On the secondary endpoint of mean
change in NPI-NH Psychosis score at week 12, pimavanserin
maintained the improvement on psychosis observed at the week 6
primary endpoint, but did not statistically separate from
placebo.
In the -019 Study, pimavanserin was generally well tolerated and
the safety profile was consistent with what has been observed in
previous studies. Based on a preliminary analysis of safety data,
the most common adverse events reported were falls, urinary tract
infection and agitation. The mortality rate was the same in the
pimavanserin and placebo treatment groups. The mean age of patients
in the study was 86 years.
The data analysis of the Phase II -019 Study is ongoing and
ACADIA plans to present data from this study at a future medical
conference.
Conference Call and Webcast InformationACADIA will host a
conference call and webcast today, December 20, 2016 at 8:30 a.m.
Eastern Time to discuss top-line results from its Phase II trial
with pimavanserin in patients with Alzheimer’s disease psychosis.
The conference call can be accessed by dialing 844-821-1109 for
participants in the U.S. and Canada and 830-865-2550 for
international callers (reference passcode 43052480). The conference
call will be webcast live on ACADIA’s website,
www.acadia-pharm.com, under the investors section and will be
archived there until January 3, 2017. A telephone replay also may
be accessed through January 3, 2017 by dialing 855-859-2056 for
participants in the U.S. and Canada and 404-537-3406 for
international callers (reference passcode 43052480).
About Alzheimer’s Disease Psychosis (AD Psychosis)According to
the Alzheimer’s Association, around 5.4 million people in the
United States are living with Alzheimer’s disease and approximately
half are diagnosed with the disease. Studies suggest that 25 to 50
percent of patients diagnosed with Alzheimer’s disease may develop
psychosis, commonly consisting of hallucinations and delusions. AD
Psychosis is associated with more rapid cognitive and functional
decline, greater caregiver burden, and earlier
institutionalization. The FDA has not approved any drug to treat AD
Psychosis.
About PimavanserinPimavanserin is a selective serotonin inverse
agonist (SSIA) preferentially targeting 5-HT2A receptors. These
receptors are thought to play an important role in AD Psychosis.
Pimavanserin is being evaluated in an extensive clinical
development program by ACADIA across multiple other indications
including Alzheimer’s disease agitation, schizophrenia – inadequate
response, schizophrenia – negative symptoms, and major depressive
disorder. Pimavanserin (34 mg) was approved for the treatment of
hallucinations and delusions associated with Parkinson’s disease
psychosis by the FDA in April 2016 under the trade name NUPLAZID®.
NUPLAZID is not approved for patients with AD Psychosis.
About ACADIA PharmaceuticalsACADIA is a biopharmaceutical
company focused on the development and commercialization of
innovative medicines to address unmet medical needs in central
nervous system disorders. ACADIA maintains a website at
www.acadia-pharm.com to which we regularly post copies of our press
releases as well as additional information and through which
interested parties can subscribe to receive e-mail alerts.
Forward-Looking StatementsStatements in this press release that
are not strictly historical in nature are forward-looking
statements. These statements include but are not limited to
statements related to the progress and timing of ACADIA’s drug
discovery and development programs; the benefits to be derived from
NUPLAZID (pimavanserin) and ACADIA’s product candidates, including
whether pimavanserin can improve psychosis in another major
neurological disorder or be used to treat AD Psychosis; whether the
data from the -019 Study support moving forward with further
development in AD Psychosis or provide strategic momentum for the
further development of pimavanserin to address the needs of AD
Psychosis patients; and ACADIA’s plans to present data from the
-019 Study. These statements are only predictions based on current
information and expectations and involve a number of risks and
uncertainties. Actual events or results may differ materially from
those projected in any of such statements due to various factors,
including the risks and uncertainties inherent in drug discovery,
development, approval and commercialization, and in collaborations
with others, and the fact that past results of clinical trials may
not be indicative of future trial results. For a discussion of
these and other factors, please refer to ACADIA’s annual report on
Form 10-K for the year ended December 31, 2015 as well as ACADIA’s
subsequent filings with the Securities and Exchange Commission. You
are cautioned not to place undue reliance on these forward-looking
statements, which speak only as of the date hereof. This caution is
made under the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. All forward-looking statements are
qualified in their entirety by this cautionary statement and ACADIA
undertakes no obligation to revise or update this press release to
reflect events or circumstances after the date hereof, except as
required by law.
Important Safety Information and
Indication for NUPLAZID (pimavanserin) tablets
WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH
DEMENTIA-RELATED PSYCHOSISElderly patients with
dementia-related psychosis treated with antipsychotic drugs are at
an increased risk of death. NUPLAZID is not approved for the
treatment of patients with dementia-related psychosis unrelated to
the hallucinations and delusions associated with Parkinson’s
disease psychosis.
NUPLAZID is an atypical antipsychotic indicated for the
treatment of hallucinations and delusions associated with
Parkinson’s disease psychosis.
QT Interval Prolongation: NUPLAZID prolongs the QT interval. The
use of NUPLAZID should be avoided in patients with known QT
prolongation or in combination with other drugs known to prolong QT
interval including Class 1A antiarrhythmics or Class 3
antiarrhythmics, certain antipsychotic medications, and certain
antibiotics. NUPLAZID should also be avoided in patients with a
history of cardiac arrhythmias, as well as other circumstances that
may increase the risk of the occurrence of torsade de pointes
and/or sudden death, including symptomatic bradycardia, hypokalemia
or hypomagnesemia, and presence of congenital prolongation of the
QT interval.
Adverse Reactions: The most common adverse reactions (≥2% for
NUPLAZID and greater than placebo) were peripheral edema (7% vs
2%), nausea (7% vs 4%), confusional state (6% vs 3%), hallucination
(5% vs 3%), constipation (4% vs 3%), and gait disturbance (2% vs
<1%).
Drug Interactions: Strong CYP3A4 inhibitors (eg, ketoconazole)
increase NUPLAZID concentrations. Reduce the NUPLAZID dose by
one-half. Strong CYP3A4 inducers may reduce NUPLAZID exposure,
monitor for reduced efficacy. Increase in NUPLAZID dosage may be
needed.
Renal Impairment: No dosage adjustment for NUPLAZID is needed in
patients with mild to moderate renal impairment. Use of NUPLAZID is
not recommended in patients with severe renal impairment.
Hepatic Impairment: Use of NUPLAZID is not recommended in
patients with hepatic impairment. NUPLAZID has not been evaluated
in this patient population.
Pregnancy: Use of NUPLAZID in pregnant women has not been
evaluated and should therefore be used in pregnancy only if the
potential benefit justifies the potential risk to the mother and
fetus.
Pediatric Use: Safety and efficacy have not been established in
pediatric patients.
Dosage and Administration: Recommended dose: 34 mg per day,
taken orally as two 17-mg tablets once daily, without
titration.
For additional Important Safety Information, including boxed
warning, please see the full Prescribing Information for NUPLAZID
at
https://www.nuplazid.com/pdf/NUPLAZID_Prescribing_Information.pdf.
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version on businesswire.com: http://www.businesswire.com/news/home/20161220005379/en/
Investor Contact:ACADIA Pharmaceuticals Inc.Lisa Barthelemy,
(858) 558-2871ir@acadia-pharm.comorMedia Contact:Taft
CommunicationsJon Shure, (240)
426-4282jon@taftcommunications.com
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