Idorsia announces positive results of the two Japanese registration studies with clazosentan - Seite 3

Jean-Paul Clozel MD and Chief Executive Officer of Idorsia commented:
“I would like to congratulate the Japanese team, which under the leadership of Dr. Satoshi Tanaka, has driven the development of clazosentan with such enthusiasm, determination, and scientific excellence. The results are highly clinically relevant and bring significant advancement for patients while confirming a safety profile that should not limit the use of the drug. The data are very impressive and give us further reason to intensify our efforts to finish the recruitment into the global REACT study as soon as possible.”

Jean-Paul concluded on a personal note:
“Martine and I have worked on the role of endothelin and the potential of endothelin receptor antagonism in aSAH for more than 25 years, with the first publication back in 1993. We had a very clear goal; to help patients following aSAH, who are often young adults and whose lives can be devastated by the terrible consequences of cerebral vasospasm. Thanks to the creation of Idorsia, to the confidence of its investors, and determination of the team, we are now on a good track to bring a major breakthrough therapy to these patients. This is immensely rewarding for all of us.”

About the global registration program “REACT”
In February 2019, Idorsia initiated REACT, a prospective, multicenter, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to investigate the efficacy and safety of clazosentan for the prevention of clinical deterioration due to vasospasm-related delayed cerebral ischemia in adult patients following aSAH. The Phase 3 study builds upon the learnings from the previous clazosentan studies to identify patients at high risk of vasospasm and delayed cerebral ischemia, the optimal dose, the best measure to demonstrate efficacy and an optimized patient management guideline to ensure patient safety.

Approximately 400 patients – treated either with microsurgical clipping or endovascular coiling – are being enrolled at approximately 95 sites across 15 countries. Patients are randomized to receive continuous infusion of either clazosentan (15 mg/hr) or placebo prophylactically, on top of local standard of care, for a period of up to 14 days. REACT is enrolling aSAH patients identified as being at high risk of developing vasospasm and subsequent delayed cerebral ischemia because of high-volume hemorrhage, as assessed by CT scan on hospital admission. Patients experiencing asymptomatic cerebral vasospasm, as measured by angiography, within 14 days of aSAH may also be included. Completion of the study is targeted for the second half of 2022.