The proof-of-concept study of 147 patients with primary insomnia showed 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 (PSG)) 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. Almorexant was found – again in a dose-dependent fashion – to decrease latency to persistent sleep (LPS, significant finding at 400mg) and to decrease wake after sleep onset (WASO, significant finding at 400mg, 200mg and 100mg).
Jean-Paul Clozel, CEO of Actelion, said: “Our research efforts at Actelion have led to this highly innovative compound with the potential to transform how sleep disorders might be treated in the future. Actelion will support and drive the RESTORA program by putting behind it all required intellectual and material resources to fully characterize efficacy and safety of almorexant.”