ACADIA Pharmaceuticals Presents Favorable Results From Phase Ib/
2004-06-29 09:08 (New York)
PHILADELPHIA, June 29 /PRNewswire/ -- ACADIA Pharmaceuticals Inc. (Nasdaq:
ACAD) presented, at the CNS DiseasesCongress held in Philadelphia, results of a
Phase Ib/IIa clinical trial ofACP-103 in patients with Parkinson's disease and
results from a human brainreceptor occupancy study of ACP-103 performed using
position emissiontomography (PET). Results of these studies demonstrated that
ACP-103,ACADIA's proprietary 5-HT2A inverse agonist, was safe and well
tolerated inParkinson's disease patients at drug plasma levels many fold higher
thanthose required for maximal brain occupancy 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
therapiesand the use of these agents frequently results in a range of
drug-inducedside effects, including neuropsychiatric abnormalities such as
hallucinosisand psychosis 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
werereduced following ACP-103 administration. This initial finding is
consistentwith the previously demonstrated antidyskinetic activity of ACP-103
in amonkey model of Parkinson's disease. The antidyskinetic activity of
ACP-103will be examined 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
volunteersusing PET. This study demonstrated that even single, low acute doses
ofACP-103, providing peak plasma levels of approximately 10 ng/ml,
producemaximal occupancy of the relevant 5-HT2A receptors without blocking
thedopamine receptors 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. |
