- Dementia-Related Psychosis Includes
Psychosis in Patients with Alzheimer’s Disease, Dementia with Lewy
Bodies, Parkinson’s Disease Dementia, Vascular Dementia, and
Frontotemporal Dementia
- FDA Grants Breakthrough Therapy
Designation to Pimavanserin for Dementia-Related Psychosis
- Conference Call to Be Held Today at
5:00 pm ET to Discuss Phase III Development Program
ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) today announced the
initiation of HARMONY, a Phase III study to evaluate pimavanserin
for the treatment of hallucinations and delusions associated with
dementia-related psychosis, a serious medical condition for which
there is no therapy approved by the U.S. Food and Drug
Administration (FDA). The company also announced that the FDA has
granted Breakthrough Therapy Designation to pimavanserin for
dementia-related psychosis. Dementia-related psychosis includes
psychosis in patients with Alzheimer’s disease, dementia with Lewy
bodies, Parkinson’s disease dementia, vascular dementia, and
frontotemporal dementia.
If the clinical development program is successful, and
pimavanserin is ultimately approved by the FDA for the treatment of
dementia-related psychosis, it would represent a significant
expansion of the approved use of pimavanserin. Currently,
pimavanserin is the only drug approved by the FDA for the treatment
of hallucinations and delusions associated with Parkinson’s disease
psychosis. It is marketed under the trade name NUPLAZID®.
“We are pleased the FDA has agreed to an efficient development
path for pimavanserin in this broad indication and granted
Breakthrough Therapy Designation in recognition of this serious
unmet need,” said Serge Stankovic, M.D., M.S.P.H., ACADIA’s
Executive Vice President, Head of Research and Development.
“Initiation of our Phase III study is supported by clinical and
preclinical evidence of pimavanserin’s antipsychotic activity
without detrimental effects on cognitive function or other side
effects associated with antipsychotics currently used off-label for
this indication.”
Around 8 million people in the United States are living with
dementia and approximately half are diagnosed with the disease.
Studies suggest that approximately 30% of patients with dementia
have psychosis, commonly consisting of hallucinations and
delusions. Serious consequences have been associated with severe or
persistent psychosis in patients with dementia such as repeated
hospital admissions, earlier progression to nursing home care, more
rapid progression of dementia, and increased risk of morbidity and
mortality.
“With receipt of FDA’s Breakthrough Therapy Designation for
pimavanserin, we are able to accelerate this important program,”
said Steve Davis, President and Chief Executive Officer of ACADIA.
“Pimavanserin has a unique biological mechanism that distinguishes
it from any other antipsychotic. We believe the profile we observed
in our Phase II -019 Study in Alzheimer’s disease psychosis could
be particularly beneficial in this elderly underserved population.
In that study, pimavanserin demonstrated antipsychotic effect
without impairing cognition and we also observed a very favorable
tolerability profile. We were very excited to be the first and only
FDA approved drug for the treatment of Parkinson’s disease
psychosis and are equally excited about the potential to help many
more patients suffering from dementia-related psychosis.”
The initiation of the pivotal study in dementia-related
psychosis, referred to as HARMONY, follows an End-of-Phase II
Meeting and agreement with the FDA on the clinical development plan
and the design of the Phase III study. ACADIA believes that robust
positive results from one Phase III study together with supportive
data from prior studies with pimavanserin could serve as the basis
of a supplementary New Drug Application (sNDA) for the treatment of
hallucinations and delusions associated with dementia-related
psychosis.
Breakthrough Therapy Designation serves to expedite the
development and review by the FDA of drugs that are intended to
treat a serious or life-threatening disease or condition. The
Breakthrough Therapy Designation for dementia-related psychosis was
granted, in part, based on results of ACADIA’s Phase II -019 Study
with pimavanserin in Alzheimer’s disease psychosis and results of
the company’s Phase III -020 Study with pimavanserin in Parkinson’s
disease psychosis. This is the second Breakthrough Therapy
Designation for pimavanserin.
About the Phase III HARMONY Study
HARMONY is a Phase III, randomized, double-blind,
placebo-controlled study, evaluating the efficacy and safety of
pimavanserin for the treatment of hallucinations and delusions
associated with dementia-related psychosis. The objective of the
study is to evaluate the ability of pimavanserin to prevent relapse
of psychotic symptoms in a broad population of patients with the
most common subtypes of dementia: Alzheimer’s disease, dementia
with Lewy bodies, Parkinson’s disease dementia, vascular dementia
and frontotemporal dementia. The study will be conducted globally
and is expected to enroll approximately 360 patients.
The study includes a 12-week open-label stabilization period
during which patients with dementia-related psychosis will be
treated with pimavanserin 34 mg once daily. Dose reduction to 20 mg
once daily will be allowed if clinically justified. Following the
12-week stabilization period, patients who meet pre-specified
criteria for treatment response will then be randomized into the
double-blind period of the study to continue their pimavanserin
dose (34 mg or 20 mg per day) or be switched to placebo and
followed for up to 26 weeks or until a relapse of psychosis occurs.
The primary endpoint in the study is time to relapse in the
double-blind period.
Clinical Data Supporting Phase III Trial Design
The Phase III development plan is supported by data from two
completed clinical studies. As previously announced, in the
completed Phase II -019 Study of pimavanserin in Alzheimer’s
disease psychosis, pimavanserin demonstrated clinically meaningful
and statistically significant efficacy of pimavanserin 34 mg over
placebo on the primary endpoint as measured by the Neuropsychiatric
Inventory-Nursing Home (NPI-NH) psychosis score at week 6 of dosing
(p=0.0451). Results from this Phase II study in Alzheimer’s disease
psychosis will be presented at the 10th Clinical Trials on
Alzheimer’s Disease (CTAD) Meeting on November 3, 2017 in
Boston.
Additional clinical evidence for efficacy of pimavanserin in
dementia-related psychosis was observed in the Phase III -020 Study
in patients with Parkinson’s disease psychosis. Approximately a
quarter of the patients enrolled in the -020 Study also suffered
from mild dementia. In a pre-specified subgroup analysis of these
patients, those treated with pimavanserin observed a significant
improvement in psychosis compared to placebo. This effect was
larger than the overall average effect observed in the study.
Other
ACADIA also announced that due to the potential overlap of
clinical sites and study participants between its Phase III HARMONY
dementia-related psychosis study and the Company’s ongoing Phase II
SERENE study of pimavanserin in Alzheimer’s disease agitation, it
has decided to discontinue enrollment of new patients in the SERENE
study. Patients already enrolled will complete the study as
planned. Discontinuation of enrollment in the SERENE study will
avoid potential interference between the two studies and enable
ACADIA to focus external and internal resources on the Phase III
dementia-related psychosis program.
Conference Call and Webcast Information
ACADIA management will hold a conference call and webcast today
at 5:00 p.m. Eastern Time. The conference call may be accessed by
dialing 844-821-1109 for participants in the U.S. or Canada and
830-865-2550 for international callers (reference passcode
94813084). A telephone replay of the conference call may be
accessed through October 18, 2017 by dialing 855-859-2056 for
callers in the U.S. or Canada and 404-537-3406 for international
callers (reference passcode 94813084). The conference call also
will be webcast live on ACADIA’s website, www.acadia-pharm.com,
under the investors section and will be archived there through
October 18, 2017.
About Pimavanserin
Pimavanserin is a selective serotonin inverse agonist (SSIA)
preferentially targeting 5-HT2A receptors. These receptors are
thought to play an important role in dementia-related psychosis.
Pimavanserin is being evaluated in an extensive clinical
development program by ACADIA across multiple indications.
Pimavanserin (34 mg) was approved for the treatment of
hallucinations and delusions associated with Parkinson’s disease
psychosis by the FDA in 2016 under the trade name NUPLAZID®.
NUPLAZID is not approved for the treatment of patients with
dementia-related psychosis.
About Dementia-Related Psychosis
Around 8 million people in the United States are living with
dementia and approximately half are diagnosed with the disease.
Studies suggest that approximately 30% of patients with dementia
have psychosis, commonly consisting of hallucinations and
delusions. Dementia-related psychosis is a serious medical
condition for which there is currently no FDA-approved therapy.
Dementia-related psychosis includes psychosis in Alzheimer’s
disease, dementia with Lewy bodies, Parkinson’s disease dementia,
vascular dementia, and frontotemporal dementia. Serious
consequences have been associated with severe or persistent
psychosis in patients with dementia such as repeated hospital
admissions, earlier progression to nursing home care, more rapid
progression of dementia, and increased risk of morbidity and
mortality.
About ACADIA Pharmaceuticals
ACADIA 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 Statements
Statements 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
benefits to be derived from NUPLAZID (pimavanserin); the utility of
pimavanserin in indications other than hallucinations and delusions
associated with Parkinson’s disease psychosis, including
indications falling within dementia-related psychosis; whether the
profile observed in the Phase II -019 Study in Alzheimer’s disease
psychosis will be beneficial to elderly patients with
dementia-related psychosis; whether the development path for
dementia-related psychosis will be efficient; whether NUPLAZID will
receive a broad indication for dementia-related psychosis; whether
the approved use of NUPLAZID will be significantly expanded;
whether positive results from one Phase III study of pimavanserin
in dementia-related psychosis will be sufficient basis for the
filing or approval of an sNDA for that indication; the timing of
presentation of clinical data and results; and the timing or
results of future studies involving pimavanserin. 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 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, 2016 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)
tabletsWARNING: 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.
Contraindication: NUPLAZID is contraindicated in patients with a
history of hypersensitivity reaction to pimavanserin or any of its
components. Reactions have included rash, urticaria, tongue
swelling, circumoral edema, and throat tightness.
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/20171004006297/en/
Investor Contact:ACADIA Pharmaceuticals Inc.Lisa Barthelemy(858)
558-2871ir@acadia-pharm.comorMedia Contact:Taft CommunicationsBob
Laverty(609) 558-5570bob@taftcommunications.com
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