Idorsia's ACT0541468 meets in Phase II insomnia trials

Idorsia Ltd. (SIX:IDIA) reported data from a pair of Phase II trials in a total of 418 adults and elderly patients with insomnia showing that once-daily ACT-541468 met the primary endpoint in both trials of a significant, dose-dependent reduction in Wake After Sleep Onset (WASO) from baseline on the first 2 nights of treatment. Idorsia said the Phase II data show that ACT-541468 leads to a fast onset of sleep and a duration of action which does not exceed a normal night's sleep.

On a secondary endpoint, ACT-541468 led to a significant, dose-dependent reduction in Latency to Persistent Sleep (LPS) from baseline on the first 2 nights of treatment in both trials. ACT-541468 was generally well tolerated with no treatment-related serious adverse events reported in the double-blind, placebo-controlled, international trials...