ACADIA Pharmaceuticals Initiates Phase II Trial of Pimavanserin for Adjunctive Treatment in Patients

- November 15th, 2016

ACADIA Pharmaceuticals, a biopharmaceutical company focused on innovative treatments that address unmet medical needs in central nervous system disorders, today announced the initiation of ADVANCE, a Phase II study to evaluate pimavanserin for adjunctive treatment in patients with negative symptoms of schizophrenia.

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 ADVANCE, a Phase II study to evaluate pimavanserin for adjunctive treatment in patients with negative symptoms of schizophrenia. Studies show that about 40 to 50 percent of schizophrenia patients suffer from prominent negative symptoms. There is currently no drug approved by the U.S. Food and Drug Administration for the treatment of these negative symptoms. As a selective serotonin inverse agonist (SSIA), pimavanserin is a new class of antipsychotic medication with a distinct mechanism of action targeting serotonergic 5-HT2A receptors while avoiding activity at dopamine and other receptors commonly targeted by other antipsychotics.
“Currently available treatments do not adequately address negative
symptoms of schizophrenia, which are highly prevalent and contribute
significantly to the long term disability and functional impairment of
people with this disease,” said Serge Stankovic, M.D., M.S.P.H.,
ACADIA’s Executive Vice President, Head of Research and Development.
“With its highly selective pharmacological profile, we believe
pimavanserin may address this unmet need and improve clinical outcomes
for these patients.”
About ADVANCE
ADVANCE is a Phase II, 26-week, randomized, double-blind,
placebo-controlled, multi-center study designed to examine the efficacy
and safety of adjunctive use of pimavanserin in patients with
schizophrenia who have predominant negative symptoms. Approximately 380
patients will be randomized to receive either pimavanserin or placebo,
orally, once daily, in addition to their ongoing antipsychotic in a
flexible dosing regimen. The starting daily dose of 20 mg of
pimavanserin at baseline may be adjusted to 34 mg or 10 mg during the
first eight weeks of treatment. The primary endpoint of the study is the
change from baseline to week 26 on the Negative Symptom Assessment-16
(NSA-16) total score. Following participation in ADVANCE, patients will
be eligible to enroll in a 52-week open-label extension study.
About Schizophrenia and Negative Symptoms
According to the National Institute of Mental Health, approximately one
percent of the U.S. population develops schizophrenia during their
lifetime. Schizophrenia is a chronic, debilitating mental illness
characterized by thought disorder, emotional and cognitive dysfunction,
and behavioral disturbances. These disturbances may include positive
symptoms, such as hallucinations, delusions, and disorganized speech,
and a range of negative symptoms, including flat affect, loss of
interest, emotional withdrawal, and cognitive impairment. Studies show
that about 40 to 50 percent of schizophrenia patients suffer from
prominent negative symptoms. While currently available antipsychotic
treatments for schizophrenia target positive symptoms, most patients
remain functionally impaired because of negative symptoms, cognitive
deficits and limited social function.
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 schizophrenia. 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 adjunctive treatment of patients with negative symptoms of
schizophrenia.
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
whether pimavanserin can treat the negative symptoms of schizophrenia or
improve clinical outcomes for patients experiencing such negative
symptoms. 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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