Idorsia is initiating REACT - Phase 3 registration study with clazosentan - Seite 3

REACT will enroll aSAH patients identified as being at high-risk of developing delayed ischemic neurological deficit because of high volume of their hemorrhage, as assessed by CT scan on hospital admission. Patients experiencing asymptomatic moderate to severe cerebral vasospasm within 14 days of securing the aneurysm may also be included.

 Guy Braunstein, MD and Head of Global Clinical Development, commented:
"REACT builds on the learnings from previous clinical studies with clazosentan, which have served to identify the optimal treatment dose and the characteristics of the patient that are most likely to benefit from treatment. Those studies have also established an extensive safety profile with over 1'800 patients treated. Compared to current acute intra-arterial intervention that only targets vasospasm in major blood vessels, clazosentan reaches the smaller blood vessels. It therefore has a potential to an effect across the whole brain circulation."

About the registration program in Japan
A Phase 2 study in Japanese and Korean patients showed that 10 mg/hr clazosentan significantly reduced vasospasm, and vasospasm-related morbidity and mortality events. On that basis, a registration program was initiated with clazosentan in Japan in May 2016. Aneurysmal subarachnoid hemorrhage is a significant problem in Japan with a prevalence around twice as high as in the rest of the world.

The program consists of two prospective, multicenter, double-blind, randomized, placebo-controlled studies to assess the efficacy and safety of clazosentan in reducing vasospasm, and vasospasm-related morbidity and mortality events in adult patients with aneurysmal subarachnoid hemorrhage. Patients are randomized to either 10 mg/hr clazosentan or placebo for up to a cumulative maximum of 15 days following the onset of aSAH. The two studies follow the same study design, with one enrolling patients whose aSAH was treated by surgical clipping and the other enrolling patients who were treated for aSAH by endovascular coiling. Both studies are close to full recruitment with 160 patients in each study and results are expected by the end of 2018.