Idorsia starting study to test clazosentan in certain cereblar ischemia patients

Idorsia today is initiating a Phase 3 study React to test clazosentan for the prevention of clinical deterioration due to vasospasm-related delayed cerebral ischemia in patients following an aneurysmal subarachnoid hemorrhage, it said Monday.

Aneurysmal subarachnoid hemorrhage (aSAH) is a sudden life-threatening bleeding occurring in the subarachnoid space, caused by the rupture of an aneurysm – a weak, bulging spot on the wall of a cerebral artery. Emergency surgical repair (endovascular coiling or microsurgical clipping) is required to stop the hemorrhage.

E. Francois Aldrich, Chief of Cerebrovascular Surgery Neurosurgery, University of Maryland said: “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.”

Martine Clozel, Chief Scientific Officer, said: “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.”

React study 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.

Guy Braunstein, Head of Global Clinical Development, said: “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.”