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ACADIA Pharmaceuticals to Present Preclinical Data on ACP-104, ACP-105 and Its Muscarinic Discovery Program at Experimental Biology 2008 Meeting.


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 the company will present preclinical data on its ACP-104 schizophrenia program, its ACP-105 Selective Androgen Receptor Modulator Modulator

Any device or circuit by means of which a desired signal is impressed upon a higher-frequency periodic wave known as a carrier. The process is called modulation. The modulator may vary the amplitude, frequency, or phase of the carrier.
 (SARM SARM Saskatchewan Association of Rural Municipalities
SARM Selective Androgen Receptor Modulator
SARM Department for Standardization, Metrology and Certification (Armenia)
SARM Set Asynchronous Response Mode (HDLC) 
) program, and its muscarinic muscarinic /mus·ca·rin·ic/ (mus?kah-rin´ik) denoting the cholinergic effects of muscarine on postganglionic parasympathetic neural impulses.  discovery program at the Experimental Biology 2008 Meeting to be held from April 5-9, 2008 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 the related Satellite Symposium on Recent Advances in Muscarinic Receptor Pharmacology and Therapeutics to be held from April 4-5, 2008.

ACP-104's Pro-cognitive and 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  Actions in Animal Models are Based on Simultaneous Interactions with M1, 5-HT2A, and D2 Receptors

In poster presentations titled, "ACP-104 is a Unique Atypical Antipsychotic Agent with M1 Muscarinic Activity" and "In Vivo Receptor Occupancy of ACP-104 and Clozapine clozapine /clo·za·pine/ (klo´zah-pen) a sedative and antipsychotic agent; used in the treatment of schizophrenia.

clo·za·pine
n.
," ACADIA researchers present new preclinical data on ACP-104, its novel drug candidate currently in Phase II development for 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. . The data show that ACP-104 demonstrates pro-cognitive actions in an animal model by a muscarinic M1 receptor dependent mechanism. ACADIA researchers also show that ACP-104 interacts with M1, 5-HT2A, and D2 receptors in vivo at doses that are effective in animal models of psychosis and cognition. In addition, the combined antagonism at 5-HT2A and partial agonism at D2 receptors in vivo suggests ACP-104 may produce antipsychotic activity with reduced extrapyramidal extrapyramidal /ex·tra·py·ram·i·dal/ (-pi-ram´i-d'l) outside the pyramidal tracts; see under system.

ex·tra·py·ram·i·dal
adj.
 side effects. Furthermore, the findings that ACP-104 binds to and activates M1 receptors in vivo support the potential utility of ACP-104 as a pro-cognitive antipsychotic in the treatment of schizophrenia.

ACP-105, a Novel Non-Steroidal SARM

In a poster presentation titled, "In Vitro and In Vivo Profile of a Novel Tissue Selective, Orally Bioavailable Non-Steroidal Androgen Receptor Modulator," ACADIA researchers present findings on ACP-105, a novel non-steroidal SARM. ACP-105 is shown to be as potent and efficacious as testosterone in in vitro assays without interaction at other hormone receptors. In addition, ACP-105 demonstrates potent anabolic anabolic

pertaining to or arising from anabolism.


anabolic steroid
steroids with a tissue-building effect. Testosterone is an example of a natural anabolic steroid with the, sometimes undesirable, effect of causing masculinization.
 effects on muscle and bone with minimal effect on prostrate pros·trate  
tr.v. pros·trat·ed, pros·trat·ing, pros·trates
1. To put or throw flat with the face down, as in submission or adoration:
 in preclinical models.

AC-260584, a Novel and Selective Muscarinic M1 Agonist

In poster presentations titled, "Characterization of the Intrinsic Efficacies of M1 Muscarinic Receptor Agonists" and "Pharmacological Characterization of AC-260584, a Potent and Selective M1 Muscarinic Receptor Agonist," ACADIA researchers describe the pharmacology of a novel, potent, and selective muscarinic M1 receptor subtype agonist. AC-260584 activates muscarinic M1 receptors in the brain and also has pro-cognitive actions in animal models. Further studies using a range of in vitro techniques reveal notable differences in the intrinsic activities of muscarinic M1 receptor agonists and demonstrate that allosteric allosteric /al·lo·ster·ic/ (al?o-ster´ik) pertaining to allostery.

allosteric

pertaining to an effect on the biological function of a protein, produced by a compound not directly involved in that function (an allosteric
 agonists such as AC-260584 can have high intrinsic activity at muscarinic M1 receptors.

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 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 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 has completed enrollment in 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 ACP-105

ACP-105 is a non-steroidal and selective androgen receptor agonist. ACP-105 is part of a class of molecules referred to as selective androgen receptor modulators Selective androgen receptor modulators or SARMs are a novel class of androgen receptor ligands. (The name follows the terminology currently used for similar molecules targeting the estrogen receptor, "selective estrogen receptor modulators," such as Tamoxifen.  (SARMs). SARMs may advance the standard of treatment for a variety of disorders including muscle-wasting conditions and osteoporosis, with fewer side effects as compared to current treatments based on testosterone replacement. ACP-105 has exhibited promising pharmacological properties and a favorable safety profile in preclinical testing.

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.

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 benefits to be derived from ACADIA's preclinical and drug development programs, including the potential advantages of the use of ACP-104 as a stand-alone treatment for schizophrenia, including pro-cognitive benefits, the use of ACP-105 as a treatment for bone and muscle wasting with minimal side effects, and the use of AC-260594 to activate M1 receptors and provide cognitive benefits. 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 clinical testing of ACP-104 to date will be predictive of results in later stages of development and whether preclinical testing of ACP-104, ACP-105 and AC-260584 in animal models 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, 2007 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 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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Date:Apr 4, 2008
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