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

Idorsia Pharmaceuticals Ltd. / Idorsia initiates a Phase 3 registration program with nemorexant (ACT-541468) for the treatment of insomnia . Verarbeitet und übermittelt durch Nasdaq Corporate Solutions. Für den Inhalt der Mitteilung ist der Emittent verantwortlich. Source: Globenewswire

• Idorsia to host an investor webcast to discuss the Phase 3 program today at 14:00hrs CEST

             
Allschwil, Switzerland - June 11, 2018
Idorsia Ltd (SIX: IDIA) today 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.

Insomnia is defined as a combination of dissatisfaction with sleep and a significant negative impact on daytime functioning. Dissatisfaction with sleep refers to the difficulty to initiate and/or maintain sleep on at least three nights per week for at least three months, despite adequate opportunity to sleep.

Dr. Thomas Roth, PhD, Director of the Sleep Disorder and Research Center at Henry Ford Hospital, commented:
"Good quality sleep is vital to our physical and mental health. Poor quality sleep can affect many aspects of daily life, including the ability to concentrate, work effectively, and can impact social activities. Insomnia is a distinct disorder and not merely a symptom of other disorders. It is important to take it seriously and to help patients to fall asleep and stay asleep for the right amount of time thereby positively impacting their quality of life. There are treatments available to help insomnia but they may be associated with side effects, have limited efficacy, or are not suitable for long-term use."