The Swiss pharmaceutical company Idorsia has announced that its drug candidate daridorexant significantly improved sleep onset, sleep quality, and daytime functioning of insomnia patients in a pivotal phase III trial.
The trial recruited 930 adult patients with insomnia. The company used a technique called polysomnography to measure the time taken to fall asleep and sleep maintenance – the study’s primary endpoint. The study also addressed a secondary endpoint of total sleep and daytime performance, measured using patient questionnaires and sleep diaries.
In analyses carried out at one and three months post-treatment, daridorexant significantly improved sleep onset and maintenance. The patients also reported increased overall sleep time and improved daytime performance. This came with neither a rebound after the treatment regimen ended nor a next morning ‘hangover’ effect, often seen with many sleeping medications, such as benzodiazepines.
The company aims to present its full results at upcoming congresses and in peer-reviewed publications.
“The results of this pivotal study are truly remarkable for the consistency of the benefit in sleep measures. Moreover, this is the first study to demonstrate an insomnia product can improve how the patient feels during the day,” said Guy Braunstein, Head of Global Clinical Development at Idorsia, in a public statement.
Idorsia’s drug candidate daridorexant has been under development for insomnia since the late 1990’s, and was formerly known as nemorexant. It works by blocking the action of orexin, a neuropeptide that regulates wakefulness, thereby turning down overactive wakefulness seen in insomnia patients. This differs from the mechanism of action of most sleep medications, which act through broad sedation of the brain, leaving patients with a next-day ‘hangover’.
This news represents a huge step forward for Idorsia, which was created just three years ago following Johnson & Johnson’s acquisition of Actelion. The findings have already pushed Idorsia’s share price up by almost 14% and have been hailed as a wake-up call for competitors in the insomnia field, which is generally seen as underserved.
Other notable players in the sleep disorder field include the US big pharma Merck and Japanese giant Eisai. Merck’s first-in-class dual orexin antagonist Belsomra is already approved for the treatment of insomnia in the general population and more recently in patients with mild-to-moderate Alzheimer’s Disease. Eisai’s treatment, approved by the FDA in late 2019, works by a similar mechanism to Merck and Idorsia’s drugs.
Results from a second confirmatory phase III study for daridorexant are expected later this year. Andrew Weiss, Head of Investor Relations and Corporate Communications at Idorsia, told me that the company is working towards advancing its EU dossier, and if all goes well, Idorsia will file for the US approval of daridorexant by the end of 2020.
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