Acadia Pharmaceuticals has announced results from its Phase IIb trial with ACP-104 for the treatment of schizophrenia. The study did not meet its primary endpoint of antipsychotic efficacy or any of the secondary endpoints.
Neither dose of ACP-104 demonstrated improved efficacy as compared to placebo. There was no clinically significant decrease in neutrophil counts in the study drug arms.
The ACP-104 trial was a multi-center, double-blind, placebo-controlled Phase II study designed to evaluate the safety and efficacy of ACP-104 in patients with schizophrenia who were experiencing an acute psychotic episode.
A total of 247 patients were enrolled at multiple sites in the US. Patients were randomized to one of three study arms, with patients receiving one of two doses of ACP-104 (100mg or 200mg, twice daily) or placebo for six weeks.
The primary endpoint of the trial was antipsychotic efficacy as measured by the mean change from baseline in the positive and negative syndrome scale (PANSS) total score for ACP-104 versus placebo. Secondary endpoints included the PANSS subscales and the clinical global impression severity scale.
Uli Hacksell, CEO of Acadia, said: “We clearly are disappointed in the results of this study. While we will thoroughly analyze the data to understand the outcome, we currently do not anticipate conducting further studies with ACP-104.”
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