Switzerland-based Idorsia has reported positive top-line data from the Phase III clinical trial of daridorexant for the treatment of insomnia.
Daridorexant is a dual orexin receptor antagonist. The Phase III trial assessed the safety and efficacy of the drug’s 25mg and 50mg doses in 930 adult and elderly patients.
According to the data, the drug showed efficacy on objective and subjective sleep parameters and daytime performance. It did not lead to any residual effect in the morning, or rebound or withdrawal symptoms with discontinuation.
Both drug doses significantly improved sleep onset and maintenance, along with subjective total sleep time.
The results were said to be consistent at months one and three. In addition, the drug was observed to improve patients’ daytime performance from baseline to months one and three.
Safety analysis revealed comparable adverse events rate between placebo and both treatment doses.
Treatment-emergent adverse events (TEAEs) were reported in 37.7% of patients in the 25mg and 50mg arms, compared to 34% on placebo.
The number of serious adverse events were said to be higher in the placebo group compared to the treatment groups.
Idorsia CEO Jean-Paul Clozel said: “While we designed daridorexant to have the optimal profile for a sleep medicine, I am nonetheless stunned by the results.
“Once approved, by providing daridorexant to the millions of patients with insomnia, Idorsia will have a major impact on this medical, social, and economic problem.”
Apart from the currently reported study, the Phase III registration programme of the drug involves another three-month confirmatory study, which is expected to report results in the third quarter of this year.
The programme includes a 40-week extension study. Together, the studies have recruited approximately 1,800 insomnia patients from more than 160 sites across 18 countries.