PhD | Director Therapeutic Innovation and BaseLaunch
Tel. +41 61 295 50 17stephan. emmerth@baselarea. swiss
The pharmaceutical research company Idorsia has achieved the primary endpoint of a Phase 2 study on its sleep medication. The medication is now expected to advance into a Phase 3 study.
Idorsia announced that it has completed a Phase 2 study on the efficacy of its dual orexin receptor ACT-541468 in adult and elderly patients. A total of 418 patients with insomnia participated in the study, and the results were positive: the medication showed the desired effect on sleep maintenance and onset and was generally well tolerated. The study also revealed that the efficacy is largely dependent on the dose.
Martine Clozel, Chief Scientific Officer at Idorsia, described the company’s scientists as “true pioneers in the field of orexin antagonism”, with more than 20,000 compounds synthesised and studied before ACT-541468 was selected. According to Clozel, the drug combines two important characteristics of a sleep medication: “Maintaining efficacy throughout the night, and a low potential for next-day residual effect”.
Due to the positive results of the Phase 2 study, Idorsia will consult with health authorities to progress the medication into a Phase 3 study as quickly as possible, explained Guy Braunstein, head of global clinical development.
Idorsia was spun-off from Actelion as part of the latter's acquisition by Johnson & Johnson, and the research company has been trading on the SIX Swiss Exchange since mid-June. Said CEO Jean-Paul Clozel: “We couldn’t have asked for a better start”.