- ACADIA to initiate second pivotal study in
the first half of 2020
- Conference call and webcast to be held today
at 5:00 p.m. Eastern Time
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), today announced
positive top-line results from its ADVANCE study, a 26-week,
randomized, double-blind, placebo-controlled study in 403 patients.
ADVANCE evaluated the efficacy and safety of adjunctive
pimavanserin treatment in patients with predominantly negative
symptoms of schizophrenia who have achieved adequate control of
positive symptoms with their existing antipsychotic treatment. No
drug is approved by the FDA for the treatment of the negative
symptoms of schizophrenia.
Pimavanserin demonstrated a statistically significant
improvement on the study’s primary endpoint, the change from
baseline to week 26 on the Negative Symptom Assessment-16 (NSA-16)
total score, compared to placebo (-10.4 vs. -8.5; p=0.043; effect
size = 0.21). A greater improvement in the NSA-16 total score
compared to placebo was observed in the 53.8% of patients (n=107)
who received the highest pimavanserin dose of 34 mg (-11.6 vs.
-8.5; unadjusted p=0.0065, effect size = 0.34). In this study,
pimavanserin did not separate from placebo on the key secondary
endpoint, the Personal and Social Performance (PSP) scale.
ACADIA plans to commence a second pivotal study with the 34 mg
dose of pimavanserin in the first half of 2020. Additional results
from the ADVANCE study will be presented at future scientific
meetings.
“The negative symptoms of schizophrenia such as social
withdrawal, apathy, anhedonia, loss of motivation, blunted affect,
and restricted speech contribute significantly to low function
levels, long-term disability, and increased caregiver burden,” said
Dr. Henry A. Nasrallah, M.D., Professor of Psychiatry, Neurology,
& Neuroscience, Director, Neuropsychiatry and Schizophrenia
Programs, at the University of Cincinnati College of Medicine.
“Historically, it has been a challenge for clinicians to treat and
significantly improve the negative symptoms of schizophrenia. There
are no FDA-approved treatments indicated for the treatment of the
negative symptoms of schizophrenia and there remains a serious and
significant unmet need.”
“The positive efficacy results and favorable tolerability
profile of pimavanserin observed in the ADVANCE study represent an
important step forward for patients and their families, given the
lack of currently approved treatment options for the negative
symptoms of schizophrenia,” said Serge Stankovic, M.D., M.S.P.H.,
ACADIA's President. “We are pleased with the positive efficacy
findings in this difficult to treat patient population and
identified the 34 mg dose as demonstrating greater efficacy with
favorable tolerability. We look forward to initiating a second
pivotal study with the 34 mg dose during the first half of
2020.”
In the study, pimavanserin was well-tolerated with high
completion rates of approximately 86% in both the pimavanserin and
placebo treatment groups and similar rates of adverse events
between pimavanserin (39.8%) and placebo (35.1%). Additionally, no
clinically significant differences in vital signs, weight,
metabolic syndrome or extrapyramidal symptoms were observed in the
pimavanserin group compared to placebo. Serious adverse events were
reported in 2.0% of patients on pimavanserin and 0.5% of patients
on placebo and discontinuations due to adverse events were also
low, 5.0% for pimavanserin and 3.0% for placebo.
About ADVANCE
The Phase 2 ADVANCE study was a 26-week, randomized,
double-blind, placebo-controlled, multi-center, international study
designed to examine the efficacy and safety of pimavanserin in
patients with schizophrenia who have predominant negative symptoms
while on a stable background antipsychotic therapy. 403 patients
were randomized to receive once-daily pimavanserin (n=201) or
placebo (n=202) as an adjunct treatment to their ongoing
antipsychotic in a flexible dosing regimen. The starting daily dose
of 20 mg of pimavanserin at baseline could have been adjusted to 34
mg or 10 mg during the first eight weeks of treatment. 53.8% of
patients who were randomized to receive pimavanserin completed the
trial on 34 mg, 44.7% on 20 mg, and 1.5% on 10 mg. The primary
endpoint of the study was the change from baseline to week 26 on
the Negative Symptom Assessment-16 (NSA-16) total score.
Baseline characteristics were similar across two treatment arms.
The most prevalent background antipsychotics in the study included
risperidone (38.5%), aripiprazole (32.5%), and olanzapine (28.0%).
The average age of patient in the study was 37.2 years.
Conference Call and Webcast Information
ACADIA will discuss top-line results from its ADVANCE study of
pimavanserin for adjunctive treatment for the negative symptoms of
schizophrenia via conference call and webcast today at 5:00 p.m.
Eastern Time. The conference call can be accessed by dialing
855-638-4820 for participants in the U.S. or Canada and
443-877-4067 for international callers (reference passcode
5696604). A telephone replay of the conference call may be accessed
through December 2, 2019 by dialing 855-859-2056 for callers in the
U.S. or Canada and 404-537-3406 for international callers
(reference passcode 5696604). The conference call will also be
webcast live on ACADIA’s website, www.acadia-pharm.com, in the
investors section and archived until December 25, 2019.
About Pimavanserin
Pimavanserin is a selective serotonin inverse agonist and
antagonist preferentially targeting 5-HT2A receptors. These
receptors are thought to play an important role in psychosis,
schizophrenia, depression and other neuropsychiatric disorders. In
vitro, pimavanserin demonstrated no appreciable binding affinity
for dopamine (including D2), histamine, muscarinic, or adrenergic
receptors. ACADIA is evaluating pimavanserin in an extensive
clinical development program across multiple indications with
significant unmet need including dementia-related psychosis,
adjunctive major depressive disorder, and the negative symptoms of
schizophrenia. Pimavanserin 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
dementia-related psychosis, schizophrenia or major depressive
disorder.
About Schizophrenia and Negative Symptoms
According to the National Mental Health Institute, approximately
one percent of the U.S. population develops schizophrenia during
their lifetime1. Schizophrenia is a chronic, debilitating and often
progressive mental illness characterized by disturbances in
thinking, emotional reaction, and behavior. These disturbances may
include positive symptoms, such as hallucinations and delusions,
and a range of negative symptoms, including loss of interest,
emotional withdrawal, and cognitive disturbances.
Studies show that about 40 to 50 percent of schizophrenia
patients suffer from predominant negative symptoms2. 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 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 has
developed and commercialized the first and only medicine approved
for the treatment of hallucinations and delusions associated with
Parkinson’s disease psychosis. ACADIA also has ongoing clinical
development efforts in additional areas with significant unmet
need, including dementia-related psychosis, schizophrenia, major
depressive disorder, and Rett syndrome. This press release and
further information about ACADIA can be found at:
www.acadia-pharm.com.
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 potential benefits of pimavanserin as a treatment for the
negative symptoms of schizophrenia or other central nervous system
disorders as well as the potential results of clinical trials of
pimavanserin in other indications. 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 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, 2018 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)
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.
- Contraindication: NUPLAZID is contraindicated in
patients with a history of a hypersensitivity reaction to
pimavanserin or any of its components. Rash, urticaria, and
reactions consistent with angioedema (e.g., tongue swelling,
circumoral edema, throat tightness, and dyspnea) have been
reported.
- 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:
- Coadministration with strong CYP3A4 inhibitors (e.g.,
ketoconazole) increases NUPLAZID exposure. Reduce NUPLAZID dose to
10 mg taken orally as one tablet once daily.
- Coadministration with strong or moderate CYP3A4 inducers
reduces NUPLAZID exposure. Avoid concomitant use of strong or
moderate CYP3A4 inducers with NUPLAZID.
Indication: NUPLAZID is indicated for the treatment of
hallucinations and delusions associated with Parkinson’s disease
psychosis.
Dosage and Administration: Recommended dose: 34 mg
capsule taken orally once daily, without titration.
NUPLAZID is available as 34 mg capsules and 10 mg tablets.
Please see the full Prescribing Information including Boxed
WARNING for NUPLAZID.
References 1NAMI, Mental Help, PsyCom, SAMHSA study, NIMH data
consolidation. 2Patel et al. 2015; Haro et al. 2015; Bobes et al.
2010; Chue and Lalonde, 2014.
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version on businesswire.com: https://www.businesswire.com/news/home/20191125005784/en/
Investor Contact: ACADIA Pharmaceuticals Inc. Mark Johnson, CFA
(858) 261-2771 ir@acadia-pharm.com
Media Contact: ACADIA Pharmaceuticals Inc. Maurissa Messier
(858) 768-6068 media@acadia-pharm.com
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