SAN DIEGO, Nov. 10 /PRNewswire-FirstCall/ —ACADIA Pharmaceuticals Inc.(Nasdaq: ACAD), a biopharmaceutical company utilizing innovative technology tofuel drug discovery and clinical development of novel treatments for centralnervous system disorders, today announced initial results from an ongoingclinical trial of ACP-104 in patients with schizophrenia. ACP-104 iscurrently being evaluated in three clinical trials, all of which are beingconducted in patients with schizophrenia and in collaboration with ProfessorCarol Tamminga, M.D., from the University of Texas Southwestern Medical Schoolin Dallas, Texas.
The first clinical trial is a randomized, double-blind,placebo-controlled, single ascending-dose study designed primarily to evaluatethe safety, tolerability and pharmacokinetics of ACP-104 in patients withschizophrenia. The initial results from this study are based on a total of10 patients that were administered single doses of ACP-104 or placebo onseparate days. Each patient received placebo and two distinct doses of ACP-104 ranging from 25 mg to 100 mg. Based on these initial doses administeredin the study, peak plasma levels were in the range of ACP-104 exposurepreviously observed after the administration of clozapine. ACP-104 was safeand well tolerated at all of the doses tested to date. No dose limiting orserious adverse events were observed.
No dose dependent, clinically significant changes occurred within any ofthe safety parameters in the clinical study, including vital signs, cardiacoutcomes, clinical chemistries and hematology, nor was there any patientdissatisfaction with the medication effects. There were no acute motor orcholinergic side effects. Because the doses tested to date have been welltolerated, ACADIA intends to expand the single ascending-dose study to testhigher than expected doses of ACP-104.
Dr. Tamminga, the Principal Investigator of the ACP-104 clinical studiessaid, "My experience with ACP-104 so far has been exciting. We have not yetreached dose limiting side effects with doses up to 100 mg and we are preparedto continue with higher dose levels. This and the encouraging patientresponses make me optimistic about its further development as a potentialtreatment for schizophrenia."
In addition to the single ascending-dose clinical study, ACP-104 is alsobeing evaluated in an ongoing 14-day, steady-state, double-blind,placebo-controlled multiple ascending-dose study in patients withschizophrenia. This study is designed to evaluate the safety, tolerabilityand pharmacokinetics of ACP-104, as well as to provide preliminary indicationsof antipsychotic efficacy. Furthermore, we are also conducting a single-dosepositron emission tomography (PET) study in patients with schizophrenia,designed to establish a correlation between brain receptor occupancy andplasma levels of ACP-104. ACADIA expects to report complete results from allthree of these clinical trials during the first half of 2006.
About ACP-104
ACP-104, or N-desmethylclozapine, is the major metabolite of clozapine,and is being developed by ACADIA as a potential novel, stand-alone therapy forschizophrenia. It combines an atypical antipsychotic efficacy profile withthe added potential benefit of enhanced cognition, thereby addressing one ofthe major challenges in treating schizophrenia today. ACP-104 combines M1muscarinic agonism, 5-HT2A inverse agonism, and dopamine D2 and D3 partialagonism in a single compound and, therefore, uniquely addresses what ACADIAbelieves are the three most promising target mechanisms for treatingschizophrenia. ACADIA's development program for ACP-104 is supported in partby the Stanley Medical Research Institute (SMRI). SMRI is the largest privatesource of research funding for severe mental illness and is based in Bethesda,Maryland.
About Schizophrenia
Schizophrenia is a chronic disabling mental illness characterized bydisturbances such as hallucinations and delusions as well as a range ofcognitive disturbances and negative symptoms, including social withdrawal.Cognitive disturbances and negative symptoms are believed to be the majorcause of patient's functional impairment and often prevent patients withschizophrenia from being fully contributing members of society. Despite theavailability of current antipsychotic drugs with worldwide sales ofapproximately $14 billion, cognitive disturbances are poorly addressed byexisting therapies and represent a large unmet medical need in the treatmentof schizophrenia.
Conference Call and Webcast Today
ACADIA will host a conference call and live webcast today at 5:00 p.m.Eastern Time to discuss its third quarter financial results and provide anupdate on the Company's development programs, including ACP-104. Theconference call may be accessed by dialing 800-573-4754 for participants inthe U.S. or Canada and 617-224-4325 for international callers (referencepasscode 26957802). A telephone replay of the conference call may be accessedthrough November 24, 2005 by dialing 888-286-8010 for callers in the U.S. orCanada and 617-801-6888 for international callers (reference passcode48989379). The conference call also will be webcast live on ACADIA's website,www.acadia-pharm.com, under the investors section and will be archived thereuntil November 24, 2005.
About ACADIA Pharmaceuticals
ACADIA Pharmaceuticals is a biopharmaceutical company utilizing innovativetechnology to fuel drug discovery and clinical development of novel treatmentsfor CNS disorders. ACADIA currently has four drug programs in clinicaldevelopment as well as a portfolio of preclinical and discovery assetsdirected at large unmet medical needs, including schizophrenia, Parkinson'sdisease, neuropathic pain, and glaucoma. All of the drug candidates inACADIA's product pipeline emanate from discoveries made using ACADIA'sproprietary drug discovery platform. ACADIA's corporate headquarters islocated in San Diego, California and it maintains research and developmentoperations in both San Diego and Malmo, Sweden.
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 progress and timing of ACADIA's drugdiscovery and development programs and related trials, the safety and efficacyof ACADIA's drug candidates, and the benefits to be derived from ACADIA'stechnology and drug candidates, in each case, including ACP-104. Thesestatements are only predictions based on current information and expectationsand involve a number of risks and uncertainties. Actual events or results maydiffer materially from those projected in any of such statements due tovarious factors, including the risks and uncertainties inherent in drugdiscovery, development and commercialization, collaborations with others andlitigation. For a discussion of these and other factors, please refer toACADIA's annual report on Form 10-K for the year ended December 31, 2004 filedwith the United States Securities and Exchange Commission as well as othersubsequent filings with the Securities and Exchange Commission. You arecautioned not to place undue reliance on these forward-looking statements,which speak only as of the date hereof. This caution is made under the safeharbor provisions of the Private Securities Litigation Reform Act of 1995.All forward-looking statements are qualified in their entirety by thiscautionary statement and ACADIA undertakes no obligation to revise or updatethis press release to reflect events or circumstances after the date hereof.
Contacts:
ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director, Investor Relations
Uli Hacksell, Ph.D., Chief Executive Officer
(858) 558-2871