Idorsia is initiating REACT - Phase 3 registration study with clazosentan - Seite 2

E. Francois Aldrich, M.B., Ch.B., M. Med., F.C.S. Professor of Neurosurgery, Chief of Cerebrovascular Surgery Neurosurgery, University of Maryland commented:
"It is very frustrating to see our patients survive the initial trauma of the brain hemorrhage and seemingly make a recovery, only for the vasospasm to take hold and cause significant long-term damage. Current 'rescue' therapy for cerebral vasospasm involves invasive neurovascular intervention that often needs to be repeated multiple times over the course of several days, needs to be performed by highly-trained specialists in an intensive care setting, and is itself associated with medical risks. Clazosentan may avoid or reduce this considerable ordeal for the patient, and the healthcare team."

About clazosentan
Several studies have built our understanding of clazosentan, an intravenous endothelin receptor antagonist, regarding its impact on preventing or reversing cerebral vasospasm. These studies suggest that clazosentan has the potential to prevent vasospasm-related delayed cerebral ischemia and to decrease the need for invasive neurovascular intervention.

Martine Clozel, MD and Chief Scientific Officer, commented:
"We know that endothelin plays a major role in cerebral vasospasm after aSAH. Clazosentan is an endothelin receptor antagonist which was optimized for its potential to be active in the brain and adapted to intensive care administration. Clinical studies with clazosentan have built a deep understanding of its role in preventing or reversing cerebral vasospasm. I am confident that we can now show that clazosentan can prevent vasospasm-related clinical deterioration in high risk patients."

About the REACT study
REACT is a prospective, multi-center, double-blind, randomized, placebo-controlled, parallel-group, Phase 3 study to assess the efficacy and safety of clazosentan in preventing clinical deterioration due to vasospasm-related delayed cerebral ischemia, in adult patients with aSAH. Approximately 400 patients, regardless of whether their hemorrhage has been treated with surgical clipping or endovascular coiling are expected to be enrolled. Patients will be enrolled from 100 trial sites across 15 countries who will be randomized to either 15 mg/hr clazosentan or placebo for a treatment period of up to 14 days. The study is expected to run for around 27 months.