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  • August 6, 2003
  • General

ACADIA Pharmaceuticals Successfully Completes Phase I Clinical Testing of ACP-103

Proprietary Small Molecule 5-HT2A Inverse Agonist Appears Safe and WellTolerated

SAN DIEGO, CA, and COPENHAGEN, DK, August 6, 2003 – ACADIA Pharmaceuticalsannounced today that it has successfully completed Phase I clinical testingof ACP-103, the Company's proprietary small molecule 5-HT2A inverse agonist.The study was designed to evaluate the safety, tolerability and pharmacokineticsof ACP-103 following oral administration in normal healthy volunteers. Resultsfrom the clinical trial demonstrated that ACP-103 was safe and well toleratedwith dose proportional pharmacokinetics and a long half-life supporting once-dailydosing.

A total of 49 healthy volunteers participated in this randomized, double-blind,placebo-controlled, dose-escalation study encompassing both single-dose andmultiple-dose regimens. The single-dose study evaluated five doses ranging from20 to 300 mg while the multiple dose-escalation study evaluated oral doses of50, 100, and 150 mg given once-daily for 14-days. Results from both the single-doseand multiple-dose studies demonstrated that ACP-103 exhibits dose-proportionalpharmacokinetics and possesses a long plasma half-life in humans making thisdrug ideal for once-daily dosing. In both studies ACP-103 was well toleratedwith no changes in cardiovascular and neurological function and no serious adverseevents in normal healthy volunteers

“The positive results from our Phase I testing in normal healthy volunteerssupport conclusions from our preclinical studies and suggest that ACP-103 hasideal drug-like characteristics. This strongly supports our plans to initiatePhase II studies later this year,” said Uli Hacksell, Ph.D., ACADIA'sChief Executive Officer. “The unique profile of ACP-103 and other proprietarycompounds in our 5-HT2A development program may lead to exciting new treatmentapproaches to a broad range of important neuropsychiatric indications, includingtreatment-induced dysfunction in Parkinson's disease, psychosis in schizophrenia,mania, and Alzheimer's disease and disordered sleep.”

ACADIA Pharmaceuticals is a drug discovery and development company that efficientlydiscovers novel small molecule drug candidates using its proprietary chemical-genomicsplatform. ACADIA has applied its platform to generate a broad discovery pipelinedirected at large unmet medical needs including Parkinson's disease, chronicpain, psychosis, and glaucoma. Two of ACADIA's drug candidates have beensuccessfully advanced from initial discovery to clinical development, and severaladditional programs are in late-stage preclinical testing.

ACADIA's corporate headquarters as well as its biological research facilitiesare located in San Diego, California and its chemistry research facilities arelocated in Copenhagen, Denmark.

Contacts:
ACADIA Pharmaceuticals
Uli Hacksell, Ph.D., Chief Executive Officer
Robert E. Davis, Ph.D., EVP of Drug Discovery and Development
+1 858-558-2871

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