SAN DIEGO, Sep 15, 2004 /PRNewswire-FirstCall via COMTEX/ —ACADIA Pharmaceuticals Inc.(Nasdaq: ACAD), a biopharmaceutical company utilizing innovative science tofuel drug discovery and clinical development of novel treatments for centralnervous system disorders, today reported results from a clinical study thatassessed the ability of ACP-103, ACADIA's proprietary 5-HT2A inverse agonist,to reduce the side effects associated with antipsychotic drug treatment withhaloperidol. Results of the clinical study showed that ACP-103 reduced boththe motor disturbances and hyperprolactinemia, a condition of elevatedprolactin secretion, caused by haloperidol treatment.
ACADIA is developing ACP-103 as a novel therapy for schizophrenia to beused in combination with currently available antipsychotic drugs includinghaloperidol, Zyprexa, Risperdal and Seroquel. These antipsychotics cause avariety of unfavorable side effects, including hyperprolactinemia, which canadversely affect menstrual and sexual function, and akathisia, an extremelydistressful motor disturbance characterized by feelings of inner restlessnessand an urge to move. ACP-103, when combined with existing antipsychoticdrugs, may reduce the side effects associated with these drugs and expandtheir range of efficacy.
The double-blind, placebo-controlled clinical study, conducted in Sweden,involved 18 healthy volunteers. All subjects were administered a single7.5 mg dose of haloperidol and 11 of these subjects developed measurableakathisia. In addition, the haloperidol treatment induced about a three-foldincrease in prolactin secretion.
Results of the study indicated that a single treatment with ACP-103reduced akathisia symptoms in most subjects and, importantly, that four of thesubjects had complete disappearance of haloperidol-induced akathisia asmeasured on the Barnes Subjective-Distress Rating Scale. Researchers observedthat maximal reductions appeared at the time of peak plasma levels of ACP-103following a single 100 mg dose that produced plasma levels approximatelyequivalent to those achieved at steady state following chronic once dailyadministration of a 20 mg dose of ACP-103. In addition, ACP-103 reducedhaloperidol-induced increases in prolactin secretion by 33%. This reductionis highly statistically significant (p<0.001, paired t-test). Thepharmacokinetics of haloperidol and ACP-103 were not affected by theirco-administration, indicating a lack of drug-drug interactions between thesetwo drugs. No serious adverse events were reported in this study.
Akathisia and hyperprolactinemia are troubling side effects of mostexisting antipyschotic drugs. Akathisia can lead to high levels of discomfortand ultimately is a major contributor to patient noncompliance. Patients withschizophrenia displaying hyperprolactinemia may be at high risk of developingosteoporosis and other side effects including decreased libido and thedevelopment of breast tissue in men.
"We are delighted that the results of this clinical study suggest that theadjunctive use of ACP-103 has the ability to reduce the side effectsassociated with antipsychotic drug treatment," said Mark R. Brann, Ph.D.,ACADIA's President and Chief Scientific Officer. "This is the first of aseries of studies in our Phase II program that will examine the ability ofACP-103 to work in combination with existing antipsychotic drugs for moreoptimal drug therapy. ACADIA has discovered that most antipsychotic drugs,including haloperidol and the market leaders Zyprexa, Risperdal and Seroquel,lack sufficient activity at 5-HT2A receptors. By adding ACP-103 on top ofthese antipsychotic drugs, we believe that one can optimize activity at 5-HT2Areceptors relative to activity at D2 receptors to improve the efficacy andreduce the side effects of this important class of drugs."
About ACP-103
ACP-103 is a small molecule drug candidate that ACADIA discovered and isdeveloping as an adjunctive therapy for schizophrenia and as a therapy fortreatment-induced dysfunction in Parkinson's disease. ACP-103 is a potent andselective inverse agonist that blocks the activity of a key serotonin receptorknown as the 5-HT2A receptor. ACP-103 has been shown to be safe and welltolerated in all Phase I clinical studies and initial Phase II clinical trialsconducted to date. ACADIA is currently conducting a multi-center Phase IIclinical trial with ACP-103 designed to evaluate the efficacy and safety ofthis drug candidate in Parkinson's disease patients who suffer fromtreatment-induced psychosis.
About Schizophrenia
Schizophrenia is a debilitating mental illness characterized bydisturbances such as hallucinations and delusions as well as a range ofnegative symptoms. Despite the availability of a variety of currentantipsychotic drugs with worldwide sales exceeding $12 billion, many symptomsassociated with this disease are poorly addressed by existing therapies. Manypatients with schizophrenia stop taking their antipsychotic medication becauseof lack of efficacy and because of the side effects they experience.Expanding the efficacy profile and reducing the side effects of these drugsrepresent important medical advances in schizophrenia therapy.
About ACADIA Pharmaceuticals
ACADIA Pharmaceuticals is a biopharmaceutical company utilizing innovativescience to fuel drug discovery and clinical development of novel treatmentsfor central nervous system disorders. ACADIA currently has five drug programsin clinical and preclinical development directed at large unmet medical needsand major commercial markets, including Parkinson's disease, schizophrenia,chronic pain, and glaucoma. Using its proprietary drug discovery platform,ACADIA has discovered all of the drug candidates in its product pipeline.ACADIA's headquarters and biological research facilities are located in SanDiego, California and its chemistry research facilities are located inCopenhagen, Denmark.
Forward Looking Statements
Statements in this press release that are not strictly historical innature are forward-looking statements. These statements include but are notlimited to statements related to the efficacy and development of ACP-103.These statements are only predictions based on current information andexpectations and involve a number of risks and uncertainties. Actual eventsor results may differ materially from those projected in any of suchstatements due to various factors, including the risks and uncertaintiesinherent in drug development and commercialization. For a discussion of theseand other factors, please refer to the company's registration statement onForm S-1 as well as other subsequent filings with the Securities and ExchangeCommission.
For further information, please contact: Uli Hacksell, Ph.D., ChiefExecutive Officer of ACADIA Pharmaceuticals Inc., +1-858-558-2871.