Acadia expects to begin phase 3 clinical trials of ACP-103 for Parkinson's disease in early 2007

By Jennifer Lanning Drey

Eugene, Ore., Aug. 11 - Acadia Pharmaceuticals Inc.'s ACP-103 for Parkinson's disease is moving into a pivotal stage in its development, said Uli Hacksell, chief executive officer of Acadia, in a presentation at the Banc of America Specialty Pharmaceuticals Conference on Friday.

The company has requested an end of phase 2 meeting with the Food and Drug Administration and expects to begin a phase 3 clinical trial in the first half of 2007, said Hacksell.

The phase 3 clinical trial will have three 80-patient arms, one being treated with placebo and two with varying doses of ACP-103, he said.

ACP-103 is being tested on patients with Parkinson's disease who suffer from treatment-induced psychosis. The drug met its primary endpoint in phase 2 clinical trials, as it did not worsen motor function.

The phase 2 trial also evaluated the secondary endpoint of antipsychotic efficacy using three different rating scales, and ACP-103 demonstrated antipsychotic effects on two of the rating scales, the company said previously.

Acadia is also moving forward with the phase 2 clinical trial of ACP-103 in patients with schizophrenia, Hacksell said. The company is currently enrolling patients in a multi-center, double-blind, placebo-controlled phase 2 clinical trial evaluating the ability of ACP-103 to provide improved therapy when used adjunctively with other antipsychotic drugs.

Acadia has enrolled its first 200 patients in the 400-patient study and is on track to report interim analysis data by the end of the year, Hacksell said.

Once the phase 2 clinical trial is complete, Acadia will consider opportunities for a strategic alliance with a company that could help with the phase 3 clinical trials and with sales and marketing of the drug, he said.

Acadia also reported in July that results from three initial clinical studies of ACP-104, its other drug for treatment of schizophrenia, demonstrated positive results. The studies found that ACP-104 is safe and well tolerated after repeated dosing of up to 600 mg per day. In addition, the initial signals of antipsychotic effects were observed within the tolerated dose range of ACP-104.

"We think that ACP-103 and ACP-104 deal with some of the key problems in schizophrenia therapy and represent real advances in schizophrenia therapy," Hacksell said.

San Diego-based Acadia is a biopharmaceutical company developing novel treatments for central nervous system disorders.

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