ACADIA Pharmaceuticals to Present Preclinical Data on Its Advanced Schizophrenia Programs at the 37th Annual Meeting of the Society for Neuroscience
Data Demonstrate Cognitive Advantages of Co-Therapy with Pimavanserin and Stand-alone Therapy with ACP-104
SAN DIEGO–(BUSINESS WIRE)–Nov. 2, 2007–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 that the company will present preclinical data on its two advanced schizophrenia programs at the 37th Annual Meeting of the Society for Neuroscience to be held in San Diego, California from November 2-5, 2007.
Pimavanserin: Improves Antipsychotic Efficacy and Cognitive Properties of Atypical Antipsychotic Drugs in Experimental Models
In a poster presentation titled “Pimavanserin, a 5-HT2A Receptor Inverse Agonist, Improves Antipsychotic Efficacy and Cognitive Properties of Atypical Antipsychotic Drugs,” ACADIA researchers present data showing pimavanserin improves the activity of a number of the most commonly used atypical antipsychotic agents in animal models predictive of antipsychotic efficacy. Pimavanserin also reversed the adverse effects of these antipsychotic agents on cognitive function, one of the untreated symptom domains of schizophrenia. These results suggest that the positive findings from ACADIA’s co-therapy trial evaluating the use of pimavanserin with risperidone may be applicable to a wide range of antipsychotic drugs.
ACP-104: Demonstrates Positive Effects on Antipsychotic Activity and Cognition in Experimental Models
In poster presentations titled “Comparison of the In Vitro and In Vivo Pharmacology of N-desmethylclozapine (ACP-104) with Other Atypical Antipsychotic Agents” and “N-desmethylclozapine (ACP-104) Induces Cellular Trafficking of Muscarinic M1 Receptors,” ACADIA researchers present data showing that ACP-104, in addition to being active in animal models predictive of antipsychotic activity, has a superior profile in animal models of cognitive function when compared to clozapine and other antipsychotic agents. Additionally, ACP-104 has a receptor profile that is distinct from and potentially advantageous to these antipsychotic agents. These findings suggest that ACP-104 may have a superior clinical profile with activity against all symptom domains (positive, negative and cognitive) in schizophrenia.
Schizophrenia is a chronic, debilitating mental illness characterized by disturbances in thinking, emotional reaction, and behavior. Approximately one percent of the population develops schizophrenia during their lifetime and more than two million people in the United States suffer from this disease. Disturbances in schizophrenia may include positive symptoms, such as hallucinations and delusions, and a range of negative symptoms, including loss of interest, emotional withdrawal and cognitive disturbances.
Pimavanserin is a novel, potent, and selective 5-HT2A inverse agonist that ACADIA discovered and is developing as a co-therapy for patients with schizophrenia. ACADIA announced positive top-line results in March 2007 from its Phase II schizophrenia co-therapy trial, demonstrating several advantages of pimavanserin when combined with a sub-maximal dose of risperidone, including enhanced efficacy, a faster onset of antipsychotic action, and an improved side-effect profile. ACADIA also is in Phase III development with pimavanserin for the treatment of Parkinson’s disease psychosis.
ACP-104, or N-desmethylclozapine, is the major metabolite of clozapine that ACADIA is developing as a novel stand-alone therapy for schizophrenia. ACP-104 provides the potential for a superior atypical antipsychotic efficacy profile with enhanced cognition. ACP-104 combines M1 muscarinic agonism, 5-HT2A inverse agonism, and D2 and D3 dopamine partial agonism in a single compound and, therefore, uniquely addresses what ACADIA believes are the three most promising target mechanisms for treating schizophrenia. ACADIA currently is conducting a Phase IIb trial to evaluate the safety and efficacy of ACP-104 in patients with schizophrenia. ACADIA’s development program for ACP-104 has been supported in part by the Stanley Medical Research Center.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders. ACADIA currently has five mid-to-late stage clinical programs as well as a portfolio of preclinical and discovery assets directed at diseases with large unmet medical needs, including schizophrenia, Parkinson’s disease psychosis, sleep maintenance insomnia, and neuropathic pain. All of the drug candidates in ACADIA’s product pipeline emanate from discoveries made using its 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 benefits to be derived from ACADIA’s drug development programs, including the potential advantages of the use of pimavanserin as a co-therapy for schizophrenia, with risperidone or other antipsychotics, and the use of ACP-104 as a stand-alone treatment for schizophrenia. 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 clinical trials, and drug development and commercialization, including the uncertainty of whether results in testing of pimavanserin and ACP-104 to date will be predictive of results in later stages of development. 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, 2006 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.
CONTACT: ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director, Investor Relations
Thomas H. Aasen, Vice President and Chief Financial Officer
SOURCE: ACADIA Pharmaceuticals Inc.