Daridorexant Phase 3 results in insomnia to be presented at SLEEP 2020

Allschwil, Switzerland – August 13, 2020

Idorsia Ltd (SIX: IDIA) today announced that the positive results from the first pivotal Phase 3 study investigating 25 and 50 mg doses of its dual orexin receptor antagonist, daridorexant, in adult and elderly patients with insomnia, are to be presented at SLEEP 2020. Due to the COVID-19 pandemic, the Associated Professional Sleep Societies (APSS) is turning SLEEP 2020, the world’s largest meeting devoted entirely to clinical sleep medicine, and sleep and circadian research, into a virtual meeting from August 27 – 30, 2020. The meeting has live-streamed content as well as on-demand recorded sessions to view.

The abstract entitled “A Phase 3, Multi-Center, Double-Blind, Randomized, Placebo-Controlled, Polysomnography Study to Assess Efficacy and Safety of Daridorexant in Adult and Elderly Insomnia Patients” will be presented as an oral presentation by Dr Thomas Roth, PhD, Director of the Sleep Disorder and Research Center at Henry Ford Hospital, and will be available on demand to registered attendees of SLEEP 2020 as part of the late-breaking program.

More information and the late breaking abstract is available in the Virtual Sleep 2020 meeting guide.

The Phase 3 program design will also be presented as a poster entitled “0521 – Daridorexant (ACT-541468), a dual orexin receptor antagonist for the treatment of insomnia disorder: double blind, randomized, Phase 3 studies for efficacy and safety in adult and elderly patients”. The poster will be available on demand to registered attendees of SLEEP 2020 and the abstract can be found in the Abstract Supplement.

In April and July 2020, Idorsia reported positive results in each of the two pivotal Phase 3 studies of daridorexant in patients with insomnia. More details and commentary can be found in the dedicated press releases (first study release), (second study release) and the investor webcasts (first study webcast), (second study webcast) which are available for replay on the corporate website.

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Notes to the editor

About the Phase 3 registration program
The Phase 3 registration program comprises two confirmatory studies of 3-month duration, together with a long-term extension study. Both pivotal studies are complete, having enrolled around 1,850 patients with insomnia at over 160 sites across 18 countries. As insomnia often presents later in life, around 40% of the recruited population was aged 65 years or older. The confirmatory multi-center, double-blind, randomized, placebo-controlled, parallel-group, polysomnography studies investigated three doses of daridorexant (10 mg, 25 mg, and 50 mg) on sleep and daytime functioning parameters, objectively in a sleep lab by polysomnography and subjectively with a daily patient diary at home.