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Acadia says results from three trials show effectiveness of ACP-104 in treatment of schizophrenia
By Lisa Kerner
Charlotte, N.C., July 13 - Acadia Pharmaceuticals Inc. said results from three initial clinical studies of ACP-104 in patients with schizophrenia demonstrate 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.
A total of 74 patients with schizophrenia were enrolled in the studies, according to a company news release.
The first randomized, double-blind, single ascending-dose study of 24 patients compared 25 mg and 250 mg doses of ACP-104 to a placebo. Results showed ACP-104 is safe and well-tolerated at all doses tested, with no observable dose-limiting toxicities or serious adverse events.
In the second trial, 40 patients were randomized to receive escalating daily doses of ACP-104 ranging from 100 mg (50 mg twice-daily) to 800 mg (400 mg twice-daily) for 14 days.
Initial signals of antipsychotic effects, measured by reductions in Positive and Negative Syndrome Scale scores, were observed in patients given the two highest tolerated doses (400 mg and 600 mg) of ACP-104.
The third study was an open label single-dose positron emission tomography study of 10 patients with schizophrenia who received single oral doses of ACP-104 ranging from 25 mg to 150 mg.
Acadia noted a relationship between plasma levels of ACP-104 and the degree of 5-HT(2A) receptor occupancy at all doses, indicating good penetration of ACP-104 into the brain. The 100 mg and 150 mg doses of ACP-104 yielded significant 5-HT(2A) receptor occupancy.
San Diego-based Acadia is a biopharmaceutical company developing novel treatments for central nervous system disorders.
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