ACADIA Pharmaceuticals Initiates Phase II Study of Pimavanserin in Alzheimer’s Disease Agitation

- October 31st, 2016

ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) announced the initiation of SERENE, a Phase II study with pimavanserin for the treatment of agitation in patients with Alzheimer’s disease (AD Agitation).

ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), a biopharmaceutical company
focused on innovative treatments that address unmet medical needs in
central nervous system disorders, today announced the initiation of
SERENE, a Phase II study with pimavanserin for the treatment of
agitation in patients with Alzheimer’s disease (AD Agitation). There is
currently no drug approved by the FDA for the treatment of AD Agitation.
Pimavanserin is a selective serotonin inverse agonist (SSIA)
preferentially targeting 5-HT2A receptors, with a distinct
mechanism of action compared to other currently available medicines used
off-label to treat AD Agitation.
“AD Agitation is a common condition and a major cause of distress for
Alzheimer’s patients, their families and caregivers,” said Serge
Stankovic, M.D., M.S.P.H., ACADIA’s Executive Vice President, Head of
Research and Development. “It also is associated with more rapid decline
and earlier institutionalization of patients with AD Agitation. With no
FDA-approved therapy for AD Agitation, there is a large, unmet need for
a new treatment option for patients.”
About the SERENE Study
SERENE is a Phase II, randomized, double-blind, placebo-controlled,
multi-center outpatient study designed to examine the efficacy and
safety of pimavanserin in approximately 430 patients with Alzheimer’s
disease who have agitation and/or aggression symptoms. Patients will be
randomized to receive once daily oral doses of 34 mg pimavanserin, 20 mg
pimavanserin or placebo for 12 weeks. The primary endpoint in the study
is a reduction in total score on the Cohen-Mansfield Agitation Inventory
(CMAI). Following participation in SERENE, patients will be eligible to
enroll in an open-label safety extension study.
About Alzheimer’s Disease Agitation (AD Agitation)
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 40 to 50
percent of patients diagnosed with Alzheimer’s disease in the United
States exhibit agitation. AD Agitation is characterized by verbal
aggression, physical aggression, and excessive motor activities. These
behavioral symptoms have been associated with more rapid cognitive
decline, greater caregiver burden, and earlier institutionalization.
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 AD Agitation. 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 U.S. Food and Drug Administration in April 2016
under the trade name NUPLAZID™. NUPLAZID is not approved for the
treatment of AD Agitation.
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 progress and timing of ACADIA’s
drug discovery and development programs, the expected design and scope
of ACADIA’s clinical trials, and the benefits to be derived from
NUPLAZID™ (pimavanserin) and ACADIA’s product candidates, including the
potential effectiveness of pimavanserin in AD Agitation patients. 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 PSYCHOSIS

Elderly 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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