ACADIA's Clinical Development of ACP-104 Supported by The Stanley Medical
Research Institute
SAN DIEGO, Aug. 3 /PRNewswire-FirstCall/ -- ACADIA Pharmaceuticals Inc.
(Nasdaq: ACAD), a biopharmaceutical company utilizing innovative science to
fuel drug discovery and clinical development of novel treatments for central
nervous system disorders, today announced publication of research linking the
mechanism of ACP-104 (N-desmethylclozapine) to the ability of clozapine to
improve cognition in patients with schizophrenia. The research, conducted by
scientists at ACADIA and Vanderbilt University and published in
'Psychopharmacology' (July 16, 2004, e-pub), shows that ACP-104, the principal
metabolite of clozapine, stimulates m1 muscarinic receptors in brain nerve
cells that play an important role in cognition.
ACADIA is developing ACP-104 as a novel therapy for schizophrenia with the
added potential for improving cognitive function. The clinical program for
ACP-104 is supported in part through a three-year development agreement with
The Stanley Medical Research Institute ("SMRI"), the leading nonprofit
organization focused on cutting edge research into treatments for
schizophrenia.
According to the published article, the muscarinic m1 receptor stimulating
properties of ACP-104 are unique among all antipsychotic drugs and may be
responsible for the superior clinical effects of clozapine. The researchers
observed that ACP-104, but not clozapine itself, is a potent and efficacious
m1 muscarinic receptor agonist. This finding resulted from a systematic
profiling of a large number of neuropsychiatric drugs and their metabolites
against a wide range of drug targets using ACADIA's proprietary functional
assays. ACADIA has built functional assays for the majority of the drug
targets in the G-protein coupled receptor and nuclear receptor gene families.
"It is widely appreciated that clozapine is unique among antipsychotic
drugs in its ability to partially address the cognitive disturbances of
schizophrenia," said Mark R. Brann, Ph.D., ACADIA's President and Chief
Scientific Officer. "The finding that ACP-104, clozapine's predominant
metabolite, is a robust m1 muscarinic receptor agonist, while clozapine itself
blocks this target, was an unexpected and truly exciting discovery. By
directly administering ACP-104, thereby avoiding the highly variable step of
having it metabolized in the body from clozapine, we hope to offer an improved
therapy that provides a more consistent cognitive benefit to patients," added
Dr. Brann.
The journal article also describes the analysis of drug blood levels
relative to clinical response obtained in two clinical trials that included
92 schizophrenia patients treated with clozapine. This analysis showed that
high ratios of ACP-104 relative to clozapine resulted in better response by
these patients in a wide range of clinical measures reflecting cognitive
performance.
"We are very excited by the finding that patients who form high levels of
ACP-104 from clozapine show a cognitive improvement," said Dr. Michael Knable,
Executive Director of SMRI. "Treatment of cognitive deficits is perhaps the
biggest challenge in schizophrenia therapy today. ACP-104 with its unique
muscarinic mechanism of action may provide a promising new approach to address
cognition and improve the lives of patients with schizophrenia."
About Schizophrenia
Schizophrenia is a debilitating mental illness characterized by
disturbances such as hallucinations and delusions as well as a range of
negative symptoms, including cognitive disturbances. Cognitive disturbances
often prevent schizophrenia patients from readjusting to society and require
patients to be under medical care for their entire lives. Despite the
availability of a variety of current antipsychotic drugs with worldwide sales
exceeding $12 billion, cognitive disturbances are poorly addressed by existing
therapies and represent a large unmet medical need in schizophrenia therapy.
About ACADIA Pharmaceuticals
ACADIA Pharmaceuticals is a biopharmaceutical company utilizing innovative
science to fuel drug discovery and clinical development of novel treatments
for central nervous system disorders. ACADIA currently has five drug programs
in clinical and preclinical development directed at large unmet medical needs
and major commercial markets, including Parkinson's disease, schizophrenia,
chronic pain, and glaucoma. Using its proprietary drug discovery platform,
ACADIA has discovered all of the drug candidates in its product pipeline.
ACADIA's headquarters and biological research facilities are located in San
Diego, California and its chemistry research facilities are located in
Copenhagen, Denmark.
About The Stanley Medical Research Institute
The Stanley Medical Research Institute is the largest private source of
research funding for severe mental illness and is based in Bethesda, Maryland.
SMRI supports research in academic and corporate environments that is directly
linked to discovering new treatments for schizophrenia and bipolar disorder.
Further information about SMRI can be obtained at http://www.stanleyresearch.org.
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 efficacy and development of ACP-104.
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 and commercialization. For a discussion of these
and other factors, please refer to the company's registration statement on
Form S-1 as well as other subsequent filings with the Securities and Exchange
Commission.
For further information, please contact: Uli Hacksell, Ph.D., Chief
Executive Officer of ACADIA Pharmaceuticals Inc., +1-858-558-2871.
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SOURCE ACADIA Pharmaceuticals Inc.
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CONTACT:
Uli Hacksell, Ph.D., Chief Executive Officer
of ACADIA Pharmaceuticals Inc., +1-858-558-2871
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