PHILADELPHIA, June 29 /PRNewswire-FirstCall/ —ACADIA PharmaceuticalsInc. (Nasdaq: ACAD) presented, at the CNS Diseases Congress held inPhiladelphia, results of a Phase Ib/IIa clinical trial of ACP-103 in patientswith Parkinson's disease and results from a human brain receptor occupancystudy of ACP-103 performed using position emission tomography (PET). Resultsof these studies demonstrated that ACP-103, ACADIA's proprietary 5-HT2Ainverse agonist, was safe and well tolerated in Parkinson's disease patientsat drug plasma levels many fold higher than those required for maximal brainoccupancy of the 5-HT2A receptors, suggesting a large therapeutic index.
ACP-103 was discovered by scientists at ACADIA and is being developed byACADIA as a therapy for treatment-induced dysfunction in Parkinson's disease,an indication with no approved therapy in the United States. Parkinson'sdisease patients are currently treated with dopamine replacement therapies andthe use of these agents frequently results in a range of drug-induced sideeffects, including neuropsychiatric abnormalities such as hallucinosis andpsychosis as well as uncontrollable movements of the limbs referred to asdyskinesias. ACADIA is currently conducting a second Phase II clinical trialof ACP-103 for treatment-induced psychosis in Parkinson's disease. ACP-103also is being developed by ACADIA as an adjunctive therapy in schizophrenia.
The Phase Ib/IIa double-blind, placebo-controlled clinical trial withACP-103 involved 12 patients with Parkinson's disease on standard dopaminereplacement therapies. This trial followed the completion of two Phase Iclinical trials that demonstrated the safety and tolerability of ACP-103following oral administration in a total of 57 healthy volunteers. The PhaseIb/IIa trial evaluated the safety and tolerability of ACP-103 in Parkinson'sdisease patients following oral administration of 25 or 100 mg doses oncedaily for 14 days. ACP-103 was well tolerated at both of these doses with noadverse events reported. Importantly, ACP-103 did not worsen the pre-existingmotor deficits of these patients, an effect commonly seen with most otherantipsychotic drugs. Together these findings further emphasize the favorablesafety profile of ACP-103. In addition, in a subset of patients entering thetrial who exhibited treatment-induced dyskinesias, these symptoms were reducedfollowing ACP-103 administration. This initial finding is consistent with thepreviously demonstrated antidyskinetic activity of ACP-103 in a monkey modelof Parkinson's disease. The antidyskinetic activity of ACP-103 will beexamined in subsequent Phase II studies.
ACADIA also reported on results from a drug receptor occupancy studyconducted at the Karolinska Institute with ACP-103 in healthy volunteers usingPET. This study demonstrated that even single, low acute doses of ACP-103,providing peak plasma levels of approximately 10 ng/ml, produce maximaloccupancy of the relevant 5-HT2A receptors without blocking the dopaminereceptors in brain regions involved in motor control.
ACADIA's presentation at the CNS Diseases Congress was entitled"Technology-Driven Opportunities in the Discovery and Development of CNSDrugs" and was given by Robert E. Davis, Ph.D., ACADIA's Executive VicePresident of Drug Discovery and Development. Dr. Davis reported that ACP-103has a therapeutic index exceeding 23-fold, based on a comparison of thehighest well tolerated plasma level at steady state with the dose required toachieve maximal occupancy of the brain 5-HT2A receptors. "This favorablesafety profile coupled with pharmacokinetic properties that appear to makeACP-103 suitable for once-daily oral administration should enable us to moveforward aggressively with our development plans for ACP-103," said Dr. Davis."The selectivity of ACP-103 for serotonin 5-HT2A receptors and its lack ofaffinity for dopamine receptors suggest that ACP-103 may be a promising newtherapy for treatment-induced dysfunction in Parkinson's disease."
ACADIA Pharmaceuticals is a biopharmaceutical company focused on thediscovery, development and commercialization of small molecule drugs for thetreatment of central nervous system disorders. ACADIA currently has five drugprograms in clinical and preclinical development directed at large unmetmedical needs and major commercial markets, including Parkinson's disease,schizophrenia, chronic pain, and glaucoma. Using its proprietary drugdiscovery platform, ACADIA has discovered all of the drug candidates in itsproduct pipeline. ACADIA's corporate headquarters and biological researchfacilities are located in San Diego, California and its chemistry researchfacilities are located in Copenhagen, 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 tolerability, safety, efficacy anddevelopment of ACP-103. These statements are only predictions based oncurrent information and expectations and involve a number of risks anduncertainties. Actual events or results may differ materially from thoseprojected in any of such statements due to various factors, including therisks and uncertainties inherent in drug development and commercialization.For a discussion of these and other factors, please refer to the company'sregistration statement on Form S-1 as well as other subsequent filings withthe Securities and Exchange Commission.
For further information, please contact Thomas H. Aasen, Vice Presidentand Chief Financial Officer of ACADIA Pharmaceuticals, +1-858-558-2871.
CONTACT:
Thomas H. Aasen
Vice President and Chief Financial Officer ofACADIA Pharmaceuticals
+1-858-558-2871