Acadia drug looks safe in schizophrenia

ACP-104 is currently being evaluated in three clinical trials, all of which are being conducted in patients with schizophrenia. The first clinical trial is a placebo-controlled, single ascending-dose study designed primarily to evaluate the safety, tolerability and pharmacokinetics of ACP-104 in patients with schizophrenia.

The initial results from this study are based on a total of 10 patients that were administered single doses of ACP-104 or placebo on separate days. Each patient received placebo and two distinct doses of ACP-104 ranging from 25mg to 100mg. Based on these initial doses administered in the study, peak plasma levels were in the range of ACP-104 exposure previously observed after the administration of clozapine, brand name Clozaril, marketed by Novartis. Because the doses tested to date have been well tolerated, Acadia intends to expand the single ascending-dose study to test higher than expected doses of ACP-104.

In addition to the single ascending-dose clinical study, ACP-104 is also being evaluated in an ongoing 14-day, steady-state, multiple ascending-dose study in patients with schizophrenia. This study is designed to evaluate the safety of ACP-104, as well as to provide preliminary indications of antipsychotic efficacy.

The company is also conducting a single-dose positron emission tomography (PET) study in patients with schizophrenia, designed to establish a correlation between brain receptor occupancy and plasma levels of ACP-104. Acadia expects to report complete results from all three of these clinical trials during the first half of 2006.

ACP-104, or N-desmethylclozapine, is the major metabolite of clozapine, currently believed to be the most effective drug for treatment resistant schizophrenia, and is being developed by Acadia as a potential novel, stand-alone therapy for the disease.