ACADIA Pharmaceuticals Successfully Completes Phase I Clinical Testing of ACP-103
Proprietary Small Molecule 5-HT2A Inverse Agonist Appears Safe and Well Tolerated
SAN DIEGO, CA, and COPENHAGEN, DK, August 6, 2003 – ACADIA Pharmaceuticals announced today that it has successfully completed Phase I clinical testing of ACP-103, the Company’s proprietary small molecule 5-HT2A inverse agonist. The study was designed to evaluate the safety, tolerability and pharmacokinetics of ACP-103 following oral administration in normal healthy volunteers. Results from the clinical trial demonstrated that ACP-103 was safe and well tolerated with dose proportional pharmacokinetics and a long half-life supporting once-daily dosing.
A total of 49 healthy volunteers participated in this randomized, double-blind, placebo-controlled, dose-escalation study encompassing both single-dose and multiple-dose regimens. The single-dose study evaluated five doses ranging from 20 to 300 mg while the multiple dose-escalation study evaluated oral doses of 50, 100, and 150 mg given once-daily for 14-days. Results from both the single-dose and multiple-dose studies demonstrated that ACP-103 exhibits dose-proportional pharmacokinetics and possesses a long plasma half-life in humans making this drug ideal for once-daily dosing. In both studies ACP-103 was well tolerated with no changes in cardiovascular and neurological function and no serious adverse events in normal healthy volunteers
“The positive results from our Phase I testing in normal healthy volunteers support conclusions from our preclinical studies and suggest that ACP-103 has ideal drug-like characteristics. This strongly supports our plans to initiate Phase II studies later this year,” said Uli Hacksell, Ph.D., ACADIA’s Chief Executive Officer. “The unique profile of ACP-103 and other proprietary compounds in our 5-HT2A development program may lead to exciting new treatment approaches to a broad range of important neuropsychiatric indications, including treatment-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 efficiently discovers novel small molecule drug candidates using its proprietary chemical-genomics platform. ACADIA has applied its platform to generate a broad discovery pipeline directed at large unmet medical needs including Parkinson’s disease, chronic pain, psychosis, and glaucoma. Two of ACADIA’s drug candidates have been successfully advanced from initial discovery to clinical development, and several additional programs are in late-stage preclinical testing.
ACADIA’s corporate headquarters as well as its biological research facilities are located in San Diego, California and its chemistry research facilities are located in Copenhagen, Denmark.
Uli Hacksell, Ph.D., Chief Executive Officer
Robert E. Davis, Ph.D., EVP of Drug Discovery and Development