ACADIA's Clinical Development of ACP-104 Supported by The Stanley MedicalResearch Institute
SAN DIEGO, Aug. 3 /PRNewswire-FirstCall/ —ACADIA Pharmaceuticals Inc.(Nasdaq: ACAD), a biopharmaceutical company utilizing innovative science tofuel drug discovery and clinical development of novel treatments for centralnervous system disorders, today announced publication of research linking themechanism of ACP-104 (N-desmethylclozapine) to the ability of clozapine toimprove cognition in patients with schizophrenia. The research, conducted byscientists at ACADIA and Vanderbilt University and published in'Psychopharmacology' (July 16, 2004, e-pub), shows that ACP-104, the principalmetabolite of clozapine, stimulates m1 muscarinic receptors in brain nervecells that play an important role in cognition.
ACADIA is developing ACP-104 as a novel therapy for schizophrenia with theadded potential for improving cognitive function. The clinical program forACP-104 is supported in part through a three-year development agreement withThe Stanley Medical Research Institute ("SMRI"), the leading nonprofitorganization focused on cutting edge research into treatments forschizophrenia.
According to the published article, the muscarinic m1 receptor stimulatingproperties of ACP-104 are unique among all antipsychotic drugs and may beresponsible for the superior clinical effects of clozapine. The researchersobserved that ACP-104, but not clozapine itself, is a potent and efficaciousm1 muscarinic receptor agonist. This finding resulted from a systematicprofiling of a large number of neuropsychiatric drugs and their metabolitesagainst a wide range of drug targets using ACADIA's proprietary functionalassays. ACADIA has built functional assays for the majority of the drugtargets in the G-protein coupled receptor and nuclear receptor gene families.
"It is widely appreciated that clozapine is unique among antipsychoticdrugs in its ability to partially address the cognitive disturbances ofschizophrenia," said Mark R. Brann, Ph.D., ACADIA's President and ChiefScientific Officer. "The finding that ACP-104, clozapine's predominantmetabolite, is a robust m1 muscarinic receptor agonist, while clozapine itselfblocks this target, was an unexpected and truly exciting discovery. Bydirectly administering ACP-104, thereby avoiding the highly variable step ofhaving it metabolized in the body from clozapine, we hope to offer an improvedtherapy that provides a more consistent cognitive benefit to patients," addedDr. Brann.
The journal article also describes the analysis of drug blood levelsrelative to clinical response obtained in two clinical trials that included92 schizophrenia patients treated with clozapine. This analysis showed thathigh ratios of ACP-104 relative to clozapine resulted in better response bythese patients in a wide range of clinical measures reflecting cognitiveperformance.
"We are very excited by the finding that patients who form high levels ofACP-104 from clozapine show a cognitive improvement," said Dr. Michael Knable,Executive Director of SMRI. "Treatment of cognitive deficits is perhaps thebiggest challenge in schizophrenia therapy today. ACP-104 with its uniquemuscarinic mechanism of action may provide a promising new approach to addresscognition and improve the lives of patients with schizophrenia."
About Schizophrenia
Schizophrenia is a debilitating mental illness characterized bydisturbances such as hallucinations and delusions as well as a range ofnegative symptoms, including cognitive disturbances. Cognitive disturbancesoften prevent schizophrenia patients from readjusting to society and requirepatients to be under medical care for their entire lives. Despite theavailability of a variety of current antipsychotic drugs with worldwide salesexceeding $12 billion, cognitive disturbances are poorly addressed by existingtherapies and represent a large unmet medical need in schizophrenia therapy.
About ACADIA Pharmaceuticals
ACADIA Pharmaceuticals is a biopharmaceutical company utilizing innovativescience to fuel drug discovery and clinical development of novel treatmentsfor central nervous system disorders. ACADIA currently has five drug programsin clinical and preclinical development directed at large unmet medical needsand 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 SanDiego, California and its chemistry research facilities are located inCopenhagen, Denmark.
About The Stanley Medical Research Institute
The Stanley Medical Research Institute is the largest private source ofresearch funding for severe mental illness and is based in Bethesda, Maryland.SMRI supports research in academic and corporate environments that is directlylinked 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 innature are forward-looking statements. These statements include but are notlimited to statements related to the efficacy and development of ACP-104.These statements are only predictions based on current information andexpectations and involve a number of risks and uncertainties. Actual eventsor results may differ materially from those projected in any of suchstatements due to various factors, including the risks and uncertaintiesinherent in drug development and commercialization. For a discussion of theseand other factors, please refer to the company's registration statement onForm S-1 as well as other subsequent filings with the Securities and ExchangeCommission.
For further information, please contact: Uli Hacksell, Ph.D., ChiefExecutive Officer of ACADIA Pharmaceuticals Inc., +1-858-558-2871.