SAN DIEGO, June 22 /PRNewswire-FirstCall/ —ACADIA Pharmaceuticals Inc.(Nasdaq: ACAD), a biopharmaceutical company utilizing innovative technology tofuel drug discovery and clinical development of novel treatments for centralnervous system (CNS) disorders, today reported encouraging results from aplanned interim trend analysis of its ongoing multi-center Phase II clinicaltrial of ACP-103 for treatment-induced psychosis in patients with Parkinson'sdisease.
The ongoing double-blind, placebo-controlled, dose-escalation Phase IIclinical trial is designed to evaluate the efficacy and tolerability ofACP-103 in 60 Parkinson's disease patients who suffer from treatment-inducedpsychosis. The results of the interim trend analysis were based on data fromthe first 30 patients to complete the study, of which 13 patients were treatedwith ACP-103 and 17 patients were administered placebo. The interim analysisexamined trends relative to the trial's endpoints of antipsychotic efficacy,comparing baseline to 28-day performance on two rating scales used in thetrial, the Clinical Global Impression - Severity of Illness scale (CGI-S) andthe Scale for the Assessment of Positive Symptoms (SAPS). Results of theinterim analysis demonstrated that the ACP-103 treatment group showed agreater reduction in psychotic symptoms on both rating scales, relative to theplacebo treatment group. The changes in SAPS were driven by reductions inhallucinations and delusions. Only two patients dropped from the study, oneon placebo and one on ACP-103. No serious adverse events were reported.
"These interim results are encouraging and increase our confidence thatACP-103 may prove to be an effective therapy for the debilitating drug-inducedpsychosis suffered by many Parkinson's disease patients," said Uli Hacksell,Ph.D., Chief Executive Officer of ACADIA. "We remain on track to completepatient enrollment and report results from the complete Phase II trial inlate-2005 or early-2006."
All patients encompassed in the interim trend analysis were appropriatelyincluded based on their pre-existing level of psychosis as estimated by scoreson the Neuropsychiatric Inventory (NPI). Demographics were consistent withexpectations based on the patient population. The interim findings arelimited to trends relative to the trial's endpoints of efficacy and are notnecessarily indicative of the final results to be announced from the completePhase II clinical trial. ACADIA is continuing to enroll patients in the studyand, as previously announced, expects to report results from a completestatistical analysis of all clinical endpoints on all 60 patients in late-2005or early-2006.
About ACP-103
ACP-103 is a small molecule drug candidate that was discovered and isbeing developed by ACADIA as a new therapy for treatment-induced dysfunctionin patients with Parkinson's disease, an indication with no approved therapyin the United States. ACP-103 is a potent and selective 5-HT2A inverseagonist, a compound that acts to block the activity of the neurotransmitterserotonin at this key target that plays an important role in the treatment ofvarious neuropsychiatric disorders. In a previous Phase Ib/IIa clinical trialin patients with Parkinson's disease reported in 2004, ACP-103 was shown to bewell tolerated and to not worsen the core motor symptoms of this disease,unlike most existing antipsychotics that further impair motor performance inthese patients. Initial indications of antidyskinetic activity also were seenin this earlier trial.
About Parkinson's Disease
Parkinson's disease is a chronic, progressive neurological disorder thatresults from the degeneration of neurons in a region of the brain thatcontrols movement. It is marked by a number of debilitating symptoms,including tremors, limb stiffness, slowness of movements, and difficultieswith posture and balance. The severity of these symptoms tends to worsen overtime. According to the American Parkinson's Disease Association, over 1.5million people in the United States suffer from Parkinson's disease and thatnumber is expected to grow as the population ages. Parkinson's diseasepatients are currently treated with dopamine replacement therapies and the useof these agents frequently results in a range of drug-induced side effects,including neuropsychiatric abnormalities such as hallucinosis and psychosis aswell as uncontrollable and excessive movements of the limbs referred to asdyskinesias.
About ACADIA Pharmaceuticals
ACADIA Pharmaceuticals is a biopharmaceutical company utilizing innovativetechnology to fuel drug discovery and clinical development of novel treatmentsfor CNS disorders. ACADIA currently has four drug programs in clinicaldevelopment as well as a portfolio of preclinical and discovery assetsdirected at large unmet medical needs, including schizophrenia, Parkinson'sdisease, neuropathic pain, and glaucoma. Using its proprietary drug discoveryplatform, ACADIA has discovered all of the drug candidates in its productpipeline. ACADIA's corporate headquarters is located in San Diego, Californiaand it maintains research and development operations in both San Diego andScandinavia.
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 progress and timing of ACADIA'sdevelopment programs and related trials and the benefits to be derived fromACP-103. These statements are only predictions based on current informationand expectations and involve a number of risks and uncertainties. Actualevents or results may differ materially from those projected in any of suchstatements due to various factors, including the risks and uncertaintiesinherent in drug discovery, development and commercialization. In particular,interim results and results from Phase I and Phase II clinical trials are notguarantees of future results in complete trials or future trials or ofACADIA's ability to obtain regulatory approval for ACP-103. For a discussionof these and other factors, please refer to ACADIA's annual report on Form 10-K for the year ended December 31, 2004 filed with the United States Securitiesand Exchange Commission as well as other subsequent filings with theSecurities and Exchange Commission, including ACADIA's quarterly report onForm 10-Q for the quarter ended March 31, 2005. You are cautioned not toplace undue reliance on these forward-looking statements, which speak only asof the date hereof. This caution is made under the safe harbor provisions ofthe Private Securities Litigation Reform Act of 1995. All forward-lookingstatements are qualified in their entirety by this cautionary statement andACADIA undertakes no obligation to revise or update this press release toreflect events or circumstances after the date hereof.
Contacts:
ACADIA Pharmaceuticals Inc.
Lisa Barthelemy, Director, Investor Relations
Uli Hacksell, Ph.D., Chief Executive Officer
(858) 558-2871