Idorsia announces the first patient recruited into REACT - the Phase 3 registration study with clazosentan

Idorsia Pharmaceuticals Ltd. / Idorsia announces the first patient recruited into REACT - the Phase 3 registration study with clazosentan . Processed and transmitted by West Corporation. The issuer is solely responsible for the content of this announcement.

 

• REACT assesses the efficacy and safety of intravenous clazosentan for the prevention of clinical deterioration due to vasospasm-related delayed cerebral ischemia following aneurysmal subarachnoid hemorrhage (aSAH)
• On June 18, 2018, Idorsia announced the plans for REACT and held an investor webcast, please refer to the documentation on our corporate website for more information

Allschwil, Switzerland - February 5, 2019
Idorsia Ltd (SIX: IDIA) today announced that the first patient has been included into REACT, a Phase 3 registration study 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.

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 for Phase 3 evaluation and the characteristics and management of the patients that are most likely to benefit from this treatment. It is very satisfying to have achieved the milestone of first patient included into the study. It's now full steam ahead to recruit 400 patients."
  

  
Notes to the editor

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. Clazosentan was granted orphan status in Europe in 2003 and in the US in 2006.

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 and 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 over two years.