Idorsia announces positive Phase 3 results for its lead product

Insomnia is, worldwide, the most commonly reported sleep disorder and its impact is often underestimated. People who suffer from insomnia may lack the energy or motivation to exercise or to take part in social activities. It can also have a significant economic impact as it increases the risk of accident and injury on the road or in the workplace, and is a leading cause of absenteeism and reduced productivity at work.

The Phase 3 registration program for dariodorexant comprises two confirmatory studies of 3-month duration, together with a 40-week extension study which has recruited around 1,800 patients with insomnia (900 in each study) from over 160 sites across 18 countries. The encouraging results for the first of these studies have been presented today. Daridorexant at both 25 and 50 mg significantly improved sleep onset and sleep maintenance as measured objectively in a sleep lab by polysomnography. Daridorexant also significantly improved subjective total sleep time as measured daily with a patient diary at home. The results were consistently statistically significant at month 1 and at month 3, indicating sustained benefit. Furthermore, treatment with daridorexant improved patients’ daytime performance from baseline at month 1 and month 3.

Jean-Paul Clozel, MD and Chief Executive Officer of Idorsia, commented: “While we designed daridorexant to have the optimal profile for a sleep medicine, I am none-the-less stunned by the results. Once approved, by providing daridorexant to the millions of patients with insomnia, Idorsia will have a major impact on this medical, social, and economic problem. It has struck me particularly in these times of confinement that we are living through, that sleep problems are a major issue and require an extremely safe and effective drug that can be used by the many. With these results Idorsia is entering into a new era; less than 3 years since its creation, Idorsia is taking a huge step forward in delivering on the vision to become a fully-fledged biopharmaceutical company.”

Martine Clozel, MD and Chief Scientific Officer of Idorsia, commented: “Our research team has been working on the science of orexin and orexin receptors since their first description in 1998. Our initial work led us to the conclusion that antagonism of the orexin system was the key to providing a natural sleep architecture for patients with insomnia. We did not discover daridorexant by chance – we have worked very hard preclinically and clinically to find the ideal compound to unlock this amazing potential. We wanted a dual antagonist with a rapid effect, and a duration of action sufficient for the night but short enough to avoid any negative residual activity the following morning. The results we share today have made it all worthwhile and prove that we were right to persevere for over 20 years on the project. It just shows what can be achieved with tailored drug design. I am incredibly proud of the discovery team that created daridorexant.”