Acadia Pharmaceuticals Announces Top-Line Results from Phase 3 ADVANCE-2 Trial of Pimavanserin in Negative Symptoms of Schizophrenia
12 March 2024 - 7:05AM
Business Wire
- Study Did Not Meet Primary Endpoint
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD) today announced
top-line results from the Phase 3 ADVANCE-2 trial evaluating
pimavanserin for the treatment of negative symptoms of
schizophrenia. Pimavanserin did not demonstrate a statistically
significant improvement over placebo on the study’s primary
endpoint, the change from baseline to week 26 on the Negative
Symptom Assessment-16 (NSA-16) total score (-11.8 vs. -11.1;
p=0.4825; effect size=0.07). The safety and tolerability profile of
pimavanserin was consistent with previous clinical trials, showing
a low rate of adverse events.
“We are disappointed the trial did not meet its primary endpoint
given the significant unmet need in patients with negative symptoms
of schizophrenia,” said Steve Davis, Acadia’s Chief Executive
Officer. “We will continue to analyze these data with our
scientific advisors, but we do not intend to conduct any further
clinical trials with pimavanserin. We want to thank the patients,
their families, and the investigators for their contributions in
this important study.”
ADVANCE-2 was a 26-week double-blind, randomized,
placebo-controlled study of 34 milligram pimavanserin in 454 adult
patients with predominant negative symptoms of schizophrenia who
had achieved control of positive symptoms with their ongoing
antipsychotic treatment. ADVANCE-2 used the NSA-16 scale, designed
to measure change on the wide range of predominant negative
symptoms that patients experience, which looks at 16 different
items in five subscales and covers symptoms such as blunted affect,
poor socialization and lack of motivation. The change from
baseline observed in the pimavanserin arm of ADVANCE-2 was similar
to the change from baseline observed at the 34 milligram dose in
ADVANCE-1 (-11.8 vs. -11.6); however, the placebo effect in
ADVANCE-2 was higher than the placebo effect observed in ADVANCE-1
(-11.1 vs. -8.5).
In ADVANCE-2, pimavanserin was well-tolerated with an adverse
event rate of 30.4% compared with 40.3% for the placebo arm.
About Acadia Pharmaceuticals
Acadia is advancing breakthroughs in neuroscience to elevate
life. For 30 years we have been working at the forefront of
healthcare to bring vital solutions to people who need them most.
We developed and commercialized the first and only FDA-approved
drug to treat hallucinations and delusions associated with
Parkinson’s disease psychosis and the first and only FDA-approved
drug for the treatment of Rett syndrome. Our clinical-stage
development efforts are focused on treating, Prader-Willi syndrome,
Alzheimer’s disease psychosis and multiple other programs targeting
neuropsychiatric symptoms in central nervous system disorders. For
more information, visit us at Acadia.com and follow us on LinkedIn
and Twitter.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of the Private Securities Litigation Reform Act of
1995. Forward-looking statements include all statements other than
statements of historical fact and can be identified by terms such
as “intends,” “may,” “will,” “should,” “could,” “would,” “expects,”
“plans,” “anticipates,” “believes,” “estimates,” “projects,”
“predicts,” “potential” and similar expressions (including the
negative thereof) intended to identify forward-looking statements.
Forward-looking statements contained in this press release,
include, but are not limited to, statements about: (i) our clinical
development plans related to pimavanserin and (ii) the safety
profile of pimavanserin. Forward-looking statements are subject to
known and unknown risks, uncertainties, assumptions and other
factors that may cause our actual results, performance or
achievements to differ materially and adversely from those
anticipated or implied by our forward-looking statements. Such
risks, uncertainties, assumptions and other factors include, but
are not limited to: our dependency on the continued successful
commercialization of NUPLAZID and DAYBUE and our ability to
maintain or increase sales of NUPLAZID or DAYBUE; our ability to
generate or obtain the necessary capital to fund our clinical
development plans; the timing and results of our clinical trials;
our ability to maintain, protect and enhance our intellectual
property; and our ability to continue to stay in compliance with
applicable laws and regulations. Given the risks and uncertainties,
you should not place undue reliance on these forward-looking
statements. For a discussion of these and other risks,
uncertainties, assumptions and other factors that may cause our
actual results, performance or achievements to differ, please refer
to our annual report on Form 10-K for the year ended December 31,
2023 filed with the Securities and Exchange Commission on February
28, 2024, as well as our subsequent filings with the Securities and
Exchange Commission from time to time. The forward-looking
statements contained herein are made as of the date hereof, and we
undertake no obligation to update them after this date, except as
required by law.
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version on businesswire.com: https://www.businesswire.com/news/home/20240311430953/en/
Media Contact: Acadia Pharmaceuticals Inc. Deb Kazenelson (818)
395-3043 media@acadia-pharm.com
Investor Contact: Acadia Pharmaceuticals Inc. Al Kildani (858)
261-2872 ir@acadia-pharm.com
Acadia Pharmaceuticals Inc. Jessica Tieszen (858) 261-2950
ir@acadia-pharm.com
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