Date: 2018-06-01
Type of
information: Treatment of the first patient
phase: 3
Announcement: recruitment of the first patient
Company: Idorsia (Switzerland)
Product: nemorexant (ACT-541468)
Action
mechanism:
- dual orexin receptor antagonist (DORA). Orexins are neuropeptide modulators - small protein-like molecules used by neurons to communicate with each other in the brain. Orexins act functionally at the interface of alertness, energy homeostasis and reward: aversion systems, essentially to regulate vigilance and alertness states. Defects of the orexin peptides, or their receptors, are associated with wakefulness and sleep disorders.
- The anatomical distribution of orexin receptors in the brain supports the essential role that orexin plays in promoting alertness and maintaining wakefulness under situations of high motivational relevance, e.g. circadian vigilance states, reward opportunities or exposure to threats. Orexins and their receptors are highly conserved across vertebrate species.
Disease: insomnia
Therapeutic
area: CNS diseases
Country:
Trial
details:
- 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.
Latest
news:
- • On June 11, 2018, Idorsia announced that the first patients have been enrolled into the Phase 3 registration program with nemorexant (proposed INN for ACT-541468), a dual orexin receptor antagonist, for the treatment of adult and elderly patients with insomnia. The Phase 3 program aims to confirm the positive results observed in the comprehensive Phase 2 clinical program in both adult and elderly patients with insomnia and is based on interaction with Health Authorities.
- The registration program comprises two confirmatory studies together with a long-term 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. As insomnia often presents later in life, around 40% of the recruited population will be aged 65 years and older. The program will investigate three doses (10 mg, 25 mg, and 50 mg), which were all effective and well tolerated in both adult and elderly patients studied in Phase 2. Patients will be treated for three months in the two trials, with the opportunity to continue treatment in a 40-week extension study.
- 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.
- The first Phase 2 study in 360 adults (ranging from 18 to 64 years), with a treatment duration of 4 weeks, showed a significant dose dependent decrease in WASO at Day 1 & 2 (average decrease of wake-time after sleep onset from baseline on the first 2 nights of treatment, measured by polysomnography). In addition, nemorexant significantly decreased LPS (latency to persistent sleep) in a dose-dependent manner. Treatment with nemorexant was generally well tolerated. There were no reports of serious adverse events related to nemorexant.
- The positive readouts of the second Phase 2 study, conducted in 58 elderly patients (ranging from 65 to 85 years), were consistent with the efficacy and safety profile of nemorexant for this patient population. The results of this study also showed a significant decrease in WASO and LPS at Day 1 & 2 in a dose-dependent manner.
Is
general: Yes
