Idorsia taking insomnia treatment to Phase 3

Idorsia announced on Monday that the first patients had been enrolled into its Phase 3 registration program with ‘nemorexant’, a dual orexin receptor antagonist, for the treatment of adult and elderly patients with insomnia.

The Swiss biotherapeutic developer said the programme aimed to confirm the positive results observed in its comprehensive Phase 2 clinical programme in both adult and elderly patients with insomnia, and was based on its interactions with health authorities.

It said the registration program comprised two confirmatory studies together with a long-term extension study, which would recruit a total of 1,800 patients with insomnia from more than 160 sites across 18 countries, and was expected to run for around two years.

As insomnia often presented later in life, Idorsia said around 40% of the recruited population would be aged 65 years and older.

The programme would 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 would be treated for three months in the two trials, with the opportunity to continue treatment in a 40-week extension study.

Idorsia said insomnia was defined as a combination of dissatisfaction with sleep and a significant negative impact on daytime functioning.

Dissatisfaction with sleep referred to the difficulty to initiate and maintain sleep on at least three nights per week for at least three months, despite adequate opportunity to sleep.

, 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,” said Dr Thomas Roth, director of the Sleep Disorder and Research Center at Henry Ford Hospital.

“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.”

Dr Roth said it was important to take the condition 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.”

Martine Clozel, managing director and chief scientific officer at Idorsia, added that dual orexin receptor antagonism specifically targeted excessive alertness, in contrast to treatments of insomnia that acted via broad sedation of the central nervous system.

“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 said it had worked closely with patients to design the registration programme through the development of a tailored patient reported outcome instrument.

That validated tool would be used to measure the impact of nemorexant on daytime performance.

Idorsia said it would continue its patient focus through the conduct of a patient preference study, with the aim of the study to collect information on what patients considered important with regards to safety and efficacy of a sleep therapy.

“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,” said Guy Braunstein, managing director and head of global clinical development at Idorsia.

“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 characterise 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.”