Idorsia announces the first patient recruited into REACT - the Phase 3 registration study with clazosentan - Seite 2

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 (or minimally symptomatic) moderate to severe cerebral vasospasm within 14 days of the aneurysm-rupture may also be included.

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

The bleeding and the release of a vasoconstrictor, endothelin, by the neighboring vascular endothelium, causes many patients to experience vasospasm (constriction of arteries in the brain). This diminishes blood flow to the brain and as a consequence, about one third of patients experience worsening of their neurological condition. Patients with thick and diffuse blood clots are at a significantly higher risk of experiencing cerebral vasospasm. Today, patients with vasospasm are typically treated with hemodynamic therapy, or more invasive neurovascular intervention such as balloon angioplasty or intra-arterial administration of vasodilators.

References

• Macdonald R L, et al. Stroke. 2012; 43(6):1463-9.
• Macdonald R L, et al. The Lancet. Neurology, 2011; 10(7):618-625.
• Macdonald R L, et al. Stroke 2008; 39:3015-3021.
• Vajkoczy P, et al. Journal of Neurosurgery 2005; 103:9-17.
• Roux S. et al. J Pharmacol Exp Ther 1997; 283:1110-1118.

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Headquartered in Switzerland - a biotech-hub of Europe - Idorsia is specialized in the discovery and development of small molecules, to transform the horizon of therapeutic options. Idorsia has a broad portfolio of innovative drugs in the pipeline, an experienced team, a fully-functional research center, and a strong balance sheet - the ideal constellation to bringing R&D efforts to business success.