ACADIA Pharmaceuticals Announces Initial Results From Ongoing Single-Dose Clinical Trial of ACP-104 in Schizophrenia Patients
SAN DIEGO, Nov. 10 /PRNewswire-FirstCall/ -- ACADIA Pharmaceuticals Inc. (Nasdaq: ACAD), a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders, today announced initial results from an ongoing clinical trial of ACP-104 in patients with schizophrenia. ACP-104 is currently being evaluated in three clinical trials, all of which are being conducted in patients with schizophrenia and in collaboration with Professor Carol Tamminga, M.D., from the University of Texas Southwestern Medical School in Dallas, Texas.
The first clinical trial is a randomized, double-blind, placebo-controlled, single ascending-dose study designed primarily to evaluate the safety, tolerability and pharmacokinetics of ACP-104 in patients with schizophrenia. The initial results from this study are based on a total of 10 patients that were administered single doses of ACP-104 or placebo on separate days. Each patient received placebo and two distinct doses of ACP- 104 ranging from 25 mg to 100 mg. Based on these initial doses administered in the study, peak plasma levels were in the range of ACP-104 exposure previously observed after the administration of clozapine. ACP-104 was safe and well tolerated at all of the doses tested to date. No dose limiting or serious adverse events were observed.
No dose dependent, clinically significant changes occurred within any of the safety parameters in the clinical study, including vital signs, cardiac outcomes, clinical chemistries and hematology, nor was there any patient dissatisfaction with the medication effects. There were no acute motor or cholinergic side effects. Because the doses tested to date have been well tolerated, ACADIA intends to expand the single ascending-dose study to test higher than expected doses of ACP-104.
Dr. Tamminga, the Principal Investigator of the ACP-104 clinical studies said, "My experience with ACP-104 so far has been exciting. We have not yet reached dose limiting side effects with doses up to 100 mg and we are prepared to continue with higher dose levels. This and the encouraging patient responses make me optimistic about its further development as a potential treatment for schizophrenia."
In addition to the single ascending-dose clinical study, ACP-104 is also being evaluated in an ongoing 14-day, steady-state, double-blind, placebo-controlled multiple ascending-dose study in patients with schizophrenia. This study is designed to evaluate the safety, tolerability and pharmacokinetics of ACP-104, as well as to provide preliminary indications of antipsychotic efficacy. Furthermore, we are also conducting a single-dose positron emission tomography (PET) study in patients with schizophrenia, designed to establish a correlation between brain receptor occupancy and plasma levels of ACP-104. ACADIA expects to report complete results from all three of these clinical trials during the first half of 2006.
ACP-104, or N-desmethylclozapine, is the major metabolite of clozapine, and is being developed by ACADIA as a potential novel, stand-alone therapy for schizophrenia. It combines an atypical antipsychotic efficacy profile with the added potential benefit of enhanced cognition, thereby addressing one of the major challenges in treating schizophrenia today. ACP-104 combines M1 muscarinic agonism, 5-HT2A inverse agonism, and dopamine D2 and D3 partial agonism in a single compound and, therefore, uniquely addresses what ACADIA believes are the three most promising target mechanisms for treating schizophrenia. ACADIA's development program for ACP-104 is supported in part by the Stanley Medical Research Institute (SMRI). SMRI is the largest private source of research funding for severe mental illness and is based in Bethesda, Maryland.
Schizophrenia is a chronic disabling mental illness characterized by disturbances such as hallucinations and delusions as well as a range of cognitive disturbances and negative symptoms, including social withdrawal. Cognitive disturbances and negative symptoms are believed to be the major cause of patient's functional impairment and often prevent patients with schizophrenia from being fully contributing members of society. Despite the availability of current antipsychotic drugs with worldwide sales of approximately $14 billion, cognitive disturbances are poorly addressed by existing therapies and represent a large unmet medical need in the treatment of 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 an update on the Company's development programs, including ACP-104. The conference call may be accessed by dialing 800-573-4754 for participants in the U.S. or Canada and 617-224-4325 for international callers (reference passcode 26957802). A telephone replay of the conference call may be accessed through November 24, 2005 by dialing 888-286-8010 for callers in the U.S. or Canada and 617-801-6888 for international callers (reference passcode 48989379). The conference call also will be webcast live on ACADIA's website, www.acadia-pharm.com, under the investors section and will be archived there until November 24, 2005.
About ACADIA Pharmaceuticals
ACADIA Pharmaceuticals is a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for CNS disorders. ACADIA currently has four drug programs in clinical development as well as a portfolio of preclinical and discovery assets directed at large unmet medical needs, including schizophrenia, Parkinson's disease, neuropathic pain, and glaucoma. All of the drug candidates in ACADIA's product pipeline emanate from discoveries made using ACADIA's proprietary drug discovery platform. ACADIA's corporate headquarters is located in San Diego, California and it maintains research and development operations in both San Diego and Malmo, Sweden.
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 progress and timing of ACADIA's drug discovery and development programs and related trials, the safety and efficacy of ACADIA's drug candidates, and the benefits to be derived from ACADIA's technology and drug candidates, in each case, including 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 discovery, development and commercialization, collaborations with others and litigation. For a discussion of these and other factors, please refer to ACADIA's annual report on Form 10-K for the year ended December 31, 2004 filed with the United States Securities and Exchange Commission as well as other subsequent filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All forward-looking statements are qualified in their entirety by this cautionary statement and ACADIA undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.
ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director, Investor Relations
Uli Hacksell, Ph.D., Chief Executive Officer