Idorsia initiates a Phase 3 registration program with nemorexant (ACT-541468) for the treatment of insomnia - Seite 2

Martine Clozel, MD and Chief Scientific Officer, commented:
"Dual orexin receptor antagonism specifically targets excessive alertness, in contrast to treatments of insomnia that act via broad sedation of the CNS. As a result, nemorexant offers the potential to induce a normal sleep architecture with a maintained efficacy in chronic insomnia patients. The pharmacokinetic/pharmacodynamic profile of nemorexant, observed in patients with insomnia, is a direct result of our targeted approach, based on early use of modeling, to identify a compound with the optimal profile for a sleep medication."

Idorsia has worked closely with patients to design the registration program through the development of a tailored Patient Reported Outcome instrument. This validated tool will be used to measure the impact of nemorexant on daytime performance. Idorsia will continue its patient focus through the conduct of a patient preference study. The aim of the study is to collect information on what patients consider important with regards to safety and efficacy of a sleep therapy.

Guy Braunstein, MD and Head of Global Clinical Development, added:
"As shown in the Phase 2 study, nemorexant has the potential to offer the combination of fast onset of sleep, maintained efficacy throughout the night, without next-day residual effects. Our confirmatory Phase 3 registration program goes one step further: we will follow patients throughout the night and during the day, which will help us to characterize the impact of the condition on the daytime performance and how it is affected by the treatment. With the patient preference study, we will further the understanding of what is important to patients, in essence we will have a preferred benefit-risk profile from the patient's perspective."

About the Phase 3 registration program
The Phase 3 registration program comprises two confirmatory studies together with a 40-week extension study which will recruit a total of 1,800 patients with insomnia from over 160 sites across 18 countries and is anticipated to run for around 2 years.

The confirmatory multi-center, double-blind, randomized, placebo-controlled, parallel-group, polysomnography studies will assess the efficacy and safety of nemorexant on objective and subjective sleep and daytime functioning parameters in adult and elderly patients with insomnia disorder. The first study will evaluate treatment with 25 mg and 50 mg doses over 3 months, while the second study will measure treatment with 10 mg and 25 mg doses over 3 months. The 40-week extension study will measure all three doses, generating data for long-term treatment of insomnia.