Mixed results seen in Actelion clazosentan trial; cerebral vasospasm reduced with no overall clinical effect

By Lisa Kerner

Charlotte, N.C., June 19 - Actelion Ltd. said preliminary analysis of the dose-finding study Conscious-1 indicate that all three doses of IV clazosentan tested (15, 5 and 1 mg/hour) have reached statistical significance versus a placebo.

However, the significant reduction in cerebral vasospasm did not translate into an overall clinical benefit as measured by a secondary endpoint of occurrence of morbidity/mortality up to week six.

The trial reached the primary endpoint of a reduction in the occurrence of moderate or severe cerebral vasospasm measured by cerebral angiography at day nine post-aneurysm rupture.

The most significant effect was seen at the 15 mg/hour dose, according to a company news release.

Additionally, treatment with clazosentan was associated with more adverse events than the placebo.

"A full data analysis and consultation with clinical experts is essential to better understand the apparent disconnect in this study between the significant reduction in cerebral vasospasm and clinical outcome assessed by the endpoint chosen," head of clinical development Isaac Kobrin said in the release.

"This full data analysis will determine the future development path."

The Conscious-1 study (Clazosentan to Overcome Neurological iSChemia and Infarct OccUrring after Subarachnoid hemorrhage) was a multi-center, international, double-blind, randomized, placebo-controlled, parallel group, dose-finding study of 413 patients.

Actelion is a biopharmaceutical company based in Allschwil, Switzerland.

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