ACADIA Pharmaceuticals Announces Completion of Enrollment of ACP-104 Phase IIb Clinical Trial Ahead of Schedule.Top-Line Results Expected in Q2 2008 SAN DIEGO -- ACADIA Acadia (əkā`dēə), Fr. Acadie, region and former French colony, E Canada, encompassing modern Nova Scotia but also New Brunswick, Prince Edward Island, and coastal areas of E Maine. After an abortive 1604 settlement of St. Pharmaceuticals Inc. (Nasdaq: ACAD ACAD Academy ACAD Academic ACAD AutoCAD (design/drafting development software by Autodesk) ACAD Acadia National Park (US National Park Service) ACAD Atherosclerotic Coronary Artery Disease ), a biopharmaceutical company utilizing innovative technology to fuel drug discovery and clinical development of novel treatments for central nervous system disorders Nervous system disorders A satisfactory classification of diseases of the nervous system should include not only the type of reaction (congenital malformation, infection, trauma, neoplasm, vascular diseases, and degenerative, metabolic, toxic, or deficiency , today announced that it has completed enrollment in its Phase IIb clinical trial with ACP-104 in patients with schizophrenia significantly ahead of expectations. ACADIA expects to report top-line results from this trial during the second quarter of 2008. "We are delighted with the rapid completion of enrollment in our ACP-104 Phase IIb schizophrenia trial and we look forward to reporting results from this exciting proof-of-concept study earlier than previously planned," said Uli Hacksell, Ph.D., Chief Executive Officer of ACADIA. "ACP-104 offers a promising new approach to the treatment of schizophrenia The concept of a cure as such in the treatment of schizophrenia remains controversial, as there is no consensus on the definition of "treatment" in the case of schizophrenia, although some criteria for the remission of symptoms have recently been suggested. that combines the potential for a superior atypical antipsychotic profile with enhanced cognition, thereby addressing a major challenge in schizophrenia therapy today. We believe that the strong interest we have seen from investigators and the accelerated pace of trial enrollment are a reflection of both the critical need for better therapy options and the potential for ACP-104 to improve the standard of care for patients who suffer from this debilitating de·bil·i·tat·ing adj. Causing a loss of strength or energy. Debilitating Weakening, or reducing the strength of. Mentioned in: Stress Reduction mental illness." The Phase IIb trial is a multi-center, double-blind, placebo-controlled study designed to evaluate the safety and efficacy of ACP-104 in patients with schizophrenia who are experiencing an acute psychotic episode. A total of 248 patients were enrolled in the trial and randomized ran·dom·ize tr.v. ran·dom·ized, ran·dom·iz·ing, ran·dom·iz·es To make random in arrangement, especially in order to control the variables in an experiment. to one of three study arms, with patients receiving either of two doses of ACP-104 (100 mg or 200 mg twice daily) or placebo. Patients receive oral doses of either ACP-104 or placebo for six weeks. The primary endpoint of the trial is antipsychotic antipsychotic /an·ti·psy·chot·ic/ (-si-kot´ik) effective in the treatment of psychotic disorders; also, an agent that so acts. Antipsychotics are a chemically diverse but pharmacologically similar class of drugs; besides psychotic efficacy as measured using the Positive and Negative Syndrome Scale, or PANSS PANSS Positive & Negative Symptom Scale, see there , an industry standard rating scale commonly used in schizophrenia trials. About ACP-104 ACP-104, or N-desmethylclozapine, is the major metabolite metabolite, organic compound that is a starting material in, an intermediate in, or an end product of metabolism. Starting materials are substances, usually small and of simple structure, absorbed by the organism as food. of clozapine clozapine /clo·za·pine/ (klo´zah-pen) a sedative and antipsychotic agent; used in the treatment of schizophrenia. clo·za·pine n. that ACADIA is developing as a novel stand-alone therapy for schizophrenia. ACP-104 is designed to provide an atypical antipsychotic efficacy profile with the added potential benefit of enhanced cognition. ACP-104 combines M1 muscarinic muscarinic /mus·ca·rin·ic/ (mus?kah-rin´ik) denoting the cholinergic effects of muscarine on postganglionic parasympathetic neural impulses. agonism, 5-HT2A inverse agonism, and D2 and D3 dopamine dopamine (dōp`əmēn), one of the intermediate substances in the biosynthesis of epinephrine and norepinephrine. See catecholamine. dopamine One of the catecholamines, widely distributed in the central nervous system. 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 has been supported in part by the Stanley Medical Research Center. About 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 Hallucinations Definition Hallucinations are false or distorted sensory experiences that appear to be real perceptions. These sensory impressions are generated by the mind rather than by any external stimuli, and may be seen, heard, felt, and even and delusions, and a range of negative symptoms, including loss of interest and emotional withdrawal, as well as cognitive disturbances. It is believed that cognitive disturbances prevent patients with schizophrenia from readjusting to society. As a result, patients with schizophrenia are normally required to be under medical care for their entire lives. Currently prescribed treatments do not effectively address or may exacerbate cognitive disturbances associated with schizophrenia. 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 “San Diego” redirects here. For other uses, see San Diego (disambiguation). San Diego is a coastal Southern California city located in the southwestern corner of the continental United States. As of 2006, the city has a population of 1,256,951. and it maintains research and development operations in both San Diego and Malmo, Sweden. Forward-Looking Statements 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, and the benefits to be derived from, ACADIA's drug development program with ACP-104 for schizophrenia, including the potential of ACP-104 to improve the standard of care and the future reporting of top-line results from the ongoing Phase IIb clinical trial. 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, and the fact that past results of clinical trials may not be indicative of future trial results. 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 ACADIA's 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 The Private Securities Litigation Reform Act of 1995 (PSLRA) implemented several significant substantive changes affecting certain cases brought under the federal securities laws, including changes related to pleading, discovery, liability, class representation and awards fees and 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. |
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