- Pimavanserin did not achieve statistical
significance on the primary endpoint, but showed a consistent trend
in improvement of psychotic symptoms (p=0.0940)
- Significant improvements observed on
secondary endpoint of PANSS negative symptoms scale sub-score
(unadjusted p=0.0474)
- Conference call and webcast to be held today
at 5:00 p.m. Eastern Time
ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), today announced
top-line results from its Phase 3 ENHANCE study, which evaluated
pimavanserin as an adjunctive treatment in adult schizophrenia
patients with persistent inadequate response to their current
antipsychotic therapy. A total of 396 patients with
moderate-to-severe psychotic symptoms were randomized to receive
either pimavanserin or placebo added to their current antipsychotic
treatment. There is currently no FDA-approved adjunctive treatment
for schizophrenia patients with inadequate response to existing
therapies.
In the study, adding pimavanserin to existing antipsychotic
treatment showed a consistent trend in improvement of psychotic
symptoms, however the results did not achieve statistical
significance on the primary endpoint, the Positive and Negative
Syndrome Scale (PANSS) total score (p=0.0940). A positive trend was
also observed on the key secondary endpoint, the Clinical Global
Impression-Severity (CGI-S) score (p=0.0543). The majority of
patients in the study were enrolled in Europe (>80%), in this
pre-specified subgroup analysis by region, consistent positive
results were observed on both the primary endpoint, PANSS total
score (unadjusted p=0.0234), and the key secondary endpoint, CGI-S
score (unadjusted p=0.0214).
Notably, in the full analysis set, pimavanserin showed
significant improvements on two pre-specified measures of negative
symptoms: the secondary endpoint PANSS negative symptoms scale
sub-score (unadjusted p=0.0474) and the exploratory endpoint PANSS
Marder negative factor score (unadjusted p=0.0362).
“I want to thank all the patients, their families, and the
investigators who participated in our ENHANCE study. Unfortunately,
we did not achieve a statistically significant reduction in the
PANSS total score in this study,” said Serge Stankovic, M.D.,
M.S.P.H., ACADIA's President. “We are pleased with the improvement
in negative symptoms observed in this study. We look forward to
completing our ongoing ADVANCE trial evaluating pimavanserin in
schizophrenia patients with predominant negative symptoms.”
Pimavanserin was well-tolerated with similar rates of adverse
events between adjunctive pimavanserin (40.4%) and adjunctive
placebo (36.9%). Adverse events reported in at least 5% of patients
in the pimavanserin group included headache, somnolence, and
insomnia. Additionally, the adjunctive use of pimavanserin did not
result in clinically significant differences in vital signs,
weight, metabolic syndrome, and extrapyramidal symptoms compared to
adjunctive placebo. Approximately 88% of pimavanserin and 96% of
placebo patients completed the study. 1% of patients in each arm
reported serious adverse events. Discontinuations due to adverse
events were low, 2.5% for pimavanserin and 0% for placebo.
In addition to the ENHANCE study, the Company is currently
evaluating pimavanserin for adjunctive treatment of schizophrenia
patients with predominant negative symptoms in the 26-week Phase 2
ADVANCE study. The primary endpoint of the study is change from
baseline on the Negative Symptom Assessment-16 total score.
Top-line results from this study are expected around year-end 2019.
There are currently no FDA-approved therapies for the treatment of
the negative symptoms of schizophrenia.
About ENHANCE
The Phase 3 ENHANCE study was a global, six-week, randomized,
double-blind, placebo-controlled, multi-center, outpatient study
designed to examine the efficacy and safety of adjunctive use of
pimavanserin in patients with schizophrenia who have not achieved
an adequate response to their current antipsychotic treatment. A
total of 396 patients were randomized (1:1) to receive either
pimavanserin, orally, once daily, in a flexible dosing regimen as
an adjunctive treatment with a background antipsychotic or placebo,
orally, once daily, with a background antipsychotic. The starting
daily dose of 20 mg of pimavanserin or matching placebo at baseline
could be adjusted to 34 mg or 10 mg during the first three weeks of
treatment. The majority of patients completed the study at the
highest dose-level (55%). Baseline characteristics were similar
across two treatment arms. The most prevalent background
antipsychotics in the study included risperidone (39.1%),
olanzapine (35.7%), and aripiprazole (21.3%). The average age of
patients in the study was 37.2 years.
Additional results from this study will be presented in the
future.
Conference Call and Webcast Information
ACADIA will discuss top-line results from its Phase 3 trial of
pimavanserin for adjunctive treatment of patients with
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
9294551). A telephone replay of the conference call may be accessed
through August 6, 2019 by dialing 855-859-2056 for callers in the
U.S. or Canada and 404-537-3406 for international callers
(reference passcode 9294551). The conference call will also be
webcast live on ACADIA’s website, www.acadia-pharm.com, in the
investors section and will be archived there until August 22,
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
receptors1. ACADIA is evaluating pimavanserin in an extensive
clinical development program across multiple indications with
significant unmet need including dementia-related psychosis,
schizophrenia, and major depressive disorder. 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 the adjunctive treatment of patients
with schizophrenia, dementia-related psychosis, or major depressive
disorder.
About Schizophrenia
According to the National Mental Health Institute, approximately
one percent of the U.S. population develops schizophrenia during
their lifetime2. 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.
According to the American Psychiatric Association, about 30% of
patients with schizophrenia have an inadequate response to
antipsychotic medications, meaning that they exhibit some
improvement, but continue to have significant psychotic symptoms.
Given the high unmet need, physicians often try multiple different
antipsychotics as monotherapy in search of better efficacy. In
addition, it is common for patients to be treated with two or more
antipsychotics concurrently which has been associated with
increased dose-related side effects and complicated dosing regimens
that can further contribute to poor treatment compliance and
subsequent relapse in these patients3.
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 for 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 1ACADIA Pharmaceuticals Inc. NUPLAZID® [package
insert]. San Diego, CA. 2NAMI, Mental Help, PsyCom, SAMHSA study,
NIMH data consolidation. 3Freudenreich O, Goff DC. Acta Psychiatr
Scand 2002;106:323–30.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190722005666/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
Acadia Pharmaceuticals (NASDAQ:ACAD)
Historical Stock Chart
From Aug 2024 to Sep 2024
Acadia Pharmaceuticals (NASDAQ:ACAD)
Historical Stock Chart
From Sep 2023 to Sep 2024