SAN DIEGO, CA and COPENHAGEN, DK, January 22, 2003 - ACADIA Pharmaceuticalsannounced today that it has initiated Phase I clinical trials for ACP-103, asmall molecule drug candidate that represents an important new approach to ameliorationof treatment-induced dysfunction in Parkinson's disease as well as a range ofneuropsychiatric disorders. ACP-103 originates entirely from ACADIA's internaldiscovery and development efforts and represents the first of two proprietarysmall molecule drugs that ACADIA plans to move into clinical testing this year.
"The advancement of ACP-103 from initial discovery to the clinic is amajor milestone for ACADIA and a strong validation of the strength of our integrateddiscovery and development organization," said Uli Hacksell, Ph.D., ACADIA'sChief Executive Officer. "This program was successfully advanced withinour projected timeline by combining the initial discovery of a novel mechanismand selective chemistries with an efficient lead optimization effort and anaccelerated preclinical development program. It is especially exciting thatACADIA may participate in late-stage development and commercialization of ACP-103for the initially targeted indication."
ACP-103 is a proprietary small molecule that acts as a selective inverse agonistat the 5-HT2A receptor. Studies of established drugs and preclinical studieswith ACP-103 have strongly suggested that this mechanism of action will be effectivein preventing treatment-induced dysfunction in Parkinson's disease as well astreating a range of neuropsychiatric disorders.
Parkinson's disease is a progressive neurodegenerative disease that afflictsmore than one million people in the United States and over four million peopleworldwide. The disease is currently treated by various drugs that enhance dopaminergicactivity in the brain. Unfortunately, nearly all patients using these therapiesdevelop treatment-induced dysfunctions, which may include hallucinosis, psychosis,and dyskinesias. There are currently no approved treatments for these disordersand clinicians often must compromise between treating Parkinson's disease itselfand accepting the range of the hallucinations and dyskinesias elicited by thedrugs used to treat this disease.
"The initial focus of our clinical program, treatment-induced dysfunctionin Parkinson's disease, represents an ideal clinical indication and an attractivecommercial opportunity for ACADIA," said Robert E. Davis, Ph.D., ACADIA'sExecutive Vice President of Drug Discovery and Development. "These arevery well defined clinical indications with clear and robust end points. Ourclinical program is based on a strong scientific rationale and will providethe opportunity to rapidly obtain safety and efficacy data on ACP-103. Due toits unique profile, ACP-103 and other development stage compounds in ACADIA's5-HT2A inverse agonist drug discovery program also may have broad utility ina range of other important indications including general anxiety disorders,other psychoses, and normalization of sleep architecture in the elderly. Weintend to expand into these larger clinical indications with ACP-103 in conjunctionwith a pharmaceutical partner."
The Phase I safety studies for ACP-103 are being conducted in the United Kingdom.ACADIA plans to incorporate the results from these initial clinical studiesinto an Investigational New Drug (IND) application that it will file later thisyear to initiate phase IIa efficacy trials in Parkinson's patients.
ACADIA Pharmaceuticals is a drug discovery and development company that efficientlydiscovers small molecule drug candidates using its proprietary chemical-genomicsplatform. ACADIA has successfully applied its platform to generate a broad discoverypipeline directed at major diseases including Parkinson's disease, psychosis,chronic pain, and glaucoma. Two of ACADIA's small molecules have been successfullyadvanced from initial discovery to clinical development. ACADIA's corporateheadquarters as well as its genomics and biological research facilities arelocated in San Diego, California and its chemistry research facilities are locatedin Copenhagen, Denmark.
Contact:
ACADIA PharmaceuticalsUnited States:Uli Hacksell, Ph.D.,CEO+1 858-558-2871
Europe:
Bo-Ragnar Tolf, Ph.D., VP of Chemistry and
Managing Director of ACADIA Pharmaceuticals A/S
+45 4329-3000