Providing comprehensive and timely information to our shareholders is important to us. The company has provided background information on our target diseases, the available clinical data, and our rationale for each Phase 3 study design, in the form of an investor webcast.
Aprocitentan Phase 3 initiation
Clazosentan Phase 3 advancing
In June 2018, Idorsia announced that it is initiating a Phase 3 study, REACT, to investigate the efficacy and safety of clazosentan for the prevention of clinical deterioration due to vasospasm-related delayed cerebral ischemia in patients following an aneurysmal subarachnoid hemorrhage. The company also gave an update on the Japanese registration program and the establishment of Idorsia Pharmaceuticals Japan. NB: An update was provided in October 2018, recruitment into the Japanese studies are now expected to continue into 2019.
Daridorexant Phase 3 initiation
In June 2018, Idorsia announced that the first patients had been enrolled in a registration study to investigate the effect of daridorexant (recommended INN for ACT-541468), a dual orexin receptor antagonist, for the treatment of adult and elderly patients with insomnia. NB: The proposed INN "nemorexant" was unsuccessful and will no longer be used in association with ACT-541468.
Lucerastat Phase 3 inititation
In May 2018, Idorsia announced that the first patient had been enrolled in a registration study to investigate the effect of lucerastat, as an oral monotherapy, for the treatment of adult patients with genetically confirmed Fabry disease, irrespective of their genetic mutation type.