Actelion's almorexant yields strong Ph II data; market awaits full details at WSC 2007

Swiss biotechnology firm Actelion says that preclinical and clinical data presented at the 2007 World Sleep Congress, in Cairns, Australia, provide evidence for the key role of its orexin receptor antagonist almorexant to significantly restore relevant clinical parameters of sleep in a dose-dependent manner. The drug is set to enter the Phase III RESTORA program by the end of the year.

Actelion's proof-of-concept, dose-ranging study of its first-in-class orexin receptor blocker was conducted in 147 patients with primary insomnia. According to the firm, the results of this trial prove that almorexant significantly improves the primary parameter of sleep efficiency - time spent sleeping while confined to bed during an eight-hour period at night, measured by polysomnography - at 400mg, 200mg and 100mg in a dose-dependent manner.

Analysis of secondary and exploratory endpoints, for which the study was not powered, also indicates that the use of almorexant results in clinically relevant improvements in important PSG-assessed sleep parameters. The drug was found - again in a dose-dependent fashion - to decrease latency to persistent sleep, significant finding at 400mg and to decrease wake after sleep onset significant finding at 400mg, 200mg and 100mg, the firm noted.