NewsACADIA Study Links ACP-104 (N-desmethylclozapine) to Improved Cognition in Schizophrenia Patients
10/11/04 - PRNewswire
SAN DIEGO, August 3 /PRNewswire/ --
- ACADIA's Clinical Development of ACP-104 Supported by The Stanley
Medical Research Institute
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 USD $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
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.
Uli Hacksell, Ph.D., Chief Executive Officer of ACADIA Pharmaceuticals Inc., +1-858-558-2871