Top-Line Results Expected in Q2 2008
SAN DIEGO—(BUSINESS WIRE)—Dec. 14, 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 thatit has completed enrollment in its Phase IIb clinical trial withACP-104 in patients with schizophrenia significantly ahead ofexpectations. ACADIA expects to report top-line results from thistrial during the second quarter of 2008.
"We are delighted with the rapid completion of enrollment in ourACP-104 Phase IIb schizophrenia trial and we look forward to reportingresults from this exciting proof-of-concept study earlier thanpreviously planned," said Uli Hacksell, Ph.D., Chief Executive Officerof ACADIA. "ACP-104 offers a promising new approach to the treatmentof schizophrenia that combines the potential for a superior atypicalantipsychotic profile with enhanced cognition, thereby addressing amajor challenge in schizophrenia therapy today. We believe that thestrong interest we have seen from investigators and the acceleratedpace of trial enrollment are a reflection of both the critical needfor better therapy options and the potential for ACP-104 to improvethe standard of care for patients who suffer from this debilitatingmental illness."
The Phase IIb trial is a multi-center, double-blind,placebo-controlled study designed to evaluate the safety and efficacyof ACP-104 in patients with schizophrenia who are experiencing anacute psychotic episode. A total of 248 patients were enrolled in thetrial and randomized to one of three study arms, with patientsreceiving either of two doses of ACP-104 (100 mg or 200 mg twicedaily) or placebo. Patients receive oral doses of either ACP-104 orplacebo 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.ACADIA's development program for ACP-104 has been supported in part bythe 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 and emotional withdrawal, as well as cognitive disturbances.It is believed 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 and timing of,and the benefits to be derived from, ACADIA's drug development programwith ACP-104 for schizophrenia, including the potential of ACP-104 toimprove the standard of care and the future reporting of top-lineresults from the ongoing Phase IIb clinical trial. These statementsare only predictions based on current information and expectations andinvolve a number of risks and uncertainties. Actual events or resultsmay differ materially from those projected in any of such statementsdue to various factors, including the risks and uncertainties inherentin drug discovery, development and commercialization, and the factthat past results of clinical trials may not be indicative of futuretrial results. For a discussion of these and other factors, pleaserefer to ACADIA's annual report on Form 10-K for the year endedDecember 31, 2006 as well as ACADIA's subsequent filings with theSecurities and Exchange Commission. You are cautioned not to placeundue reliance on these forward-looking statements, which speak onlyas of the date hereof. This caution is made under the safe harborprovisions 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 orupdate this press release to reflect events or circumstances after thedate hereof.
CONTACT: ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director, Investor Relations
Uli Hacksell, Ph.D., Chief Executive Officer
(858) 558-2871