SAN DIEGO—(BUSINESS WIRE)—June 26, 2007—ACADIA PharmaceuticalsInc. (Nasdaq: ACAD), a biopharmaceutical company utilizing innovativetechnology to fuel drug discovery and clinical development of noveltreatments for central nervous system disorders, today announced theinitiation of a Phase IIb clinical trial designed to evaluate thesafety and efficacy of ACP-104 as a treatment for patients withschizophrenia.
"ACP-104 represents a promising new approach to the treatment ofschizophrenia that combines the potential for a superior atypicalantipsychotic efficacy profile with enhanced cognition, therebyaddressing the major challenges in schizophrenia therapy today," saidUli Hacksell, Ph.D., Chief Executive Officer of ACADIA. "Theinitiation of this Phase IIb trial with ACP-104, along with ourclinical program with pimavanserin as a co-therapy for schizophrenia,underscores ACADIA's ongoing commitment to improve the standard ofcare for patients who suffer from this debilitating mental illness."
The Phase IIb trial is a multi-center, double-blind,placebo-controlled study designed to evaluate the safety and efficacyof ACP-104 in approximately 250 patients with schizophrenia who areexperiencing an acute psychotic episode. Patients in the trial will berandomized to three different study arms, which will include twodifferent doses of ACP-104 (100 mg twice daily and 200 mg twice daily)and one placebo arm. Patients will receive oral doses of eitherACP-104 or placebo for six weeks. The primary endpoint of the trial isantipsychotic efficacy as measured using the Positive and NegativeSyndrome Scale, or PANSS, an industry standard rating scale commonlyused in schizophrenia trials.
About ACP-104
ACP-104, or N-desmethylclozapine, is the major metabolite ofclozapine that ACADIA is developing as a novel stand-alone therapy forschizophrenia. ACP-104 is designed to provide an atypicalantipsychotic efficacy profile with the added potential benefit ofenhanced cognition. ACP-104 combines M1 muscarinic agonism, 5-HT2Ainverse agonism, and D2 and D3 dopamine partial agonism in a singlecompound and, therefore, uniquely addresses what ACADIA believes arethe three most promising target mechanisms for treating schizophrenia.In 2006, ACADIA announced results from three initial studies withACP-104 in patients with schizophrenia. The results of these studiesdemonstrated that initial signals of antipsychotic effects wereobserved within the tolerated dose range of ACP-104 after treatment ofup to two weeks. ACADIA's development program for ACP-104 has beensupported in part by the Stanley Medical Research Center.
About Schizophrenia
Schizophrenia is a chronic, debilitating mental illnesscharacterized by disturbances in thinking, emotional reaction, andbehavior. Approximately one percent of the population developsschizophrenia during their lifetime and more than two million peoplein the United States suffer from this disease. Disturbances inschizophrenia may include positive symptoms, such as hallucinationsand delusions, and a range of negative symptoms, including loss ofinterest, emotional withdrawal and cognitive disturbances. It isbelieved that cognitive disturbances prevent patients withschizophrenia from readjusting to society. As a result, patients withschizophrenia are normally required to be under medical care for theirentire lives. Currently prescribed treatments do not effectivelyaddress or may exacerbate cognitive disturbances associated withschizophrenia.
About ACADIA Pharmaceuticals
ACADIA is a biopharmaceutical company utilizing innovativetechnology to fuel drug discovery and clinical development of noveltreatments for central nervous system disorders. ACADIA currently hasfive mid-to-late stage clinical programs as well as a portfolio ofpreclinical and discovery assets directed at diseases with large unmetmedical needs, including schizophrenia, Parkinson's disease psychosis,sleep maintenance insomnia, and neuropathic pain. All of the drugcandidates in ACADIA's product pipeline emanate from discoveries madeusing its proprietary drug discovery platform. ACADIA's corporateheadquarters is located in San Diego, California and it maintainsresearch and development operations in both San Diego and Malmo,Sweden.
Forward-Looking Statements
Statements in this press release that are not strictly historicalin nature are forward-looking statements. These statements include butare not limited to statements related to the progress of ACADIA's drugdiscovery and development programs, the benefits to be derived fromACADIA's drug candidates, or disease treatment approach, in each case,including ACP-104, and ACADIA's future efforts in any particulardisease area. These statements are only predictions based on currentinformation and expectations and involve a number of risks anduncertainties. Actual events or results may differ materially fromthose projected in any of such statements due to various factors,including the risks and uncertainties inherent in drug discovery,development and commercialization, and the fact that past results ofclinical trials may not be indicative of future trial results. For adiscussion of these and other factors, please refer to ACADIA's annualreport on Form 10-K for the year ended December 31, 2006 as well asACADIA's subsequent filings with the Securities and ExchangeCommission. You are cautioned not to place undue reliance on theseforward-looking statements, which speak only as of the date hereof.This caution is made under the safe harbor provisions of the PrivateSecurities Litigation Reform Act of 1995. All forward-lookingstatements are qualified in their entirety by this cautionarystatement and ACADIA undertakes no obligation to revise or update thispress release to reflect events or circumstances after the datehereof.
CONTACT: ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director, Investor Relations
Thomas H. Aasen, Vice President andChief Financial Officer
858-558-2871
SOURCE: ACADIA Pharmaceuticals Inc.