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Actelion Conscious-2 study misses primary endpoint

Actelion has released the initial results of Conscious-2 (Clazosentan to Overcome Neurological iSChemia and Infarct OccUrring after Subarachnoid hemorrhage) study evaluating the safety and efficacy of Clazosentan in reducing vasospasm-related morbidity and all-cause mortality in clipped patients following aneurysmal subarachnoid hemorrhage (aSAH).

Conscious-2 primary endpoint showed a non-significant relative risk reduction of 17% in favor of Clazosentan and the safety profile of Clazosentan in Conscious-2 was comparable to previous studies with the compound in this disease.

Conscious-2 investigated the clinical benefits of Clazosentan through the primary endpoint of vasospasm-related morbidity and all-cause mortality, which includes neurological deterioration, new brain infarcts, introduction of vasospasm rescue therapy, or death from any cause.

Actelion CEO Jean-Paul Clozel said that with four marketed products, Actelion is generating the necessary revenues to continue to invest appropriately in clinical studies for more than 10 development compounds.

With regard to the ongoing Conscious-3 study in patients with aSAH that underwent coiling to secure their aneurysm, Actelion is edxpected to discuss the appropriate course of action with the Steering Committee.