September 27, 2010 | by Actelion Pharmaceuticals Ltd
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September 27, 2010, Actelion Ltd (SIX: ATLN) announced today the initial results of CONSCIOUS-2 a clinical 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).
The primary endpoint showed a non-significant relative risk reduction of 17 percent in favor of clazosentan (p=0.1). The safety profile of clazosentan in CONSCIOUS-2 was comparable to previous studies with the compound in this disease.
Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion commented: "These are, of course, disappointing results. Having embarked upon such a complex study, both in terms of design and execution, I must commend the exceptional efforts of all involved delivering a high-quality study.”
Jean-Paul Clozel continued: “Actelion will continue to focus on growing its existing business. With four marketed products, Actelion is generating the necessary revenues to continue to invest appropriately in clinical studies for our more than 10 development compounds.”
In regards to the ongoing CONSCIOUS-3 study in patients with aSAH that underwent coiling to secure their aneurysm, Actelion will discuss the appropriate course of action with the Steering Committee. The company will provide an update on the clazosentan development program in its upcoming Q3 reporting, scheduled for Thursday, 21 October 2010.
About CONSCIOUS-2
CONSCIOUS-2 (Clazosentan to Overcome Neurological iSChemia and Infarct OccUrring after Subarachnoid hemorrhage) investigated the potential 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.
CONSCIOUS-2 was a global study which concluded enrollment with over 1,150 patients with aSAH and aneurysmal surgical clipping, from more than 100 centers. Patients were randomized 2:1 to receive either 5 mg/h of clazosentan, or placebo.
Contact
Roland Haefeli Vice President, Head of Investor Relations & Public Affairs Actelion Pharmaceuticals Ltd Gewerbestrasse 16 CH-4123 Allschwil T.: 061 565 62 62 F.: 0650 624 69 36 I.: www.actelion.com
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Conclusion of this article: « CONSCIOUS-2 study with clazosentan does not meet primary endpoint »
Source: Actelion Pharmaceuticals Ltd, Press release