Actelion Fibrosis Drug Doesn't Meet Key Endpoint PDF Print E-mail
Monday, 01 March 2010 11:24
Actelion Ltd today announced the initial results of BUILD-3, a clinical study evaluating the safety and efficacy of Bosentan in patients suffering from idiopathic pulmonary fibrosis. While there was a consistent trend in favour of Bosentan, the primary endpoint, reduction in morbidity/mortality, was not met (p=0.21). The well characterized safety profile of Bosentan was confirmed.

Bosentan is an orally available dual Endothelin receptor antagonist, already approved worldwide for the treatment of pulmonary arterial hypertension under the brand name Tracleer. In the European Union and in other territories, Tracleer is also approved for the reduction of new digital ulcers in patients with Systemic Scleroderma.

Jean-Paul Clozel, M.D. and Chief Executive Officer of Actelion commented: "We are naturally disappointed with this outcome. While in BUILD-3 there is a consistent trend in favour of Bosentan, these findings do not support initiating regulatory proceedings."

Jean-Paul  Clozel continued: "We remain  convinced that Endothelin receptors are important  targets for potential future treatments in this poorly understood and rapidly  progressing form of pulmonary fibrosis.  The results of BUILD-3 suggest that a more complete blockade of both endothelin receptors - as potentially achieved with macitentan - might be needed."

The 150 patient exploratory studies with Actelion's highly potent, tissue-targeting Endothelin receptor antagonist, macitentan, is currently enrolling patients with idiopathic pulmonary fibrosis. The study is expected to be fully enrolled later this year and report data in second half of 2011.

Sources: PR Inside, MarketWatch
 
More articles :

» No Exercise Benefit with Bosentan in Systemic Sclerosis

Treatment with the endothelin receptor antagonist bosentan () failed to improve exercise capacity in patients with systemic sclerosis, a randomized trial found. After one year of treatment, there was a nonsignificant mean change in the six-minute...

» Joint Involvement And Aggressive Systemic Sclerosis

Clinical joint involvement is strikingly common in patients with systemic sclerosis () and is associated with a more active and severe disease phenotype, according to an analysis of the world’s largest systemic sclerosis (SSc) registry. proved to...

» Pulmonary Arterial Hypertension Occurrence After Liver Transplant in Systemic Sclerosis

E. Koumakis, J. Wipff, A. Kahan, Y. AllanoreReceived on January 12, 2010; accepted in revised form on April 20, 2010.Clin Exp Rheumatol 2010: 28 (Suppl. 58): S53-S54.© Copyright CLINICAL AND EXPERIMENTAL RHEUMATOLOGY 2010.E. Koumakis, J. Wipff, A....

» Therapies for Scleroderma-related Pulmonary Arterial Hypertension

Paul M. HassounPosted: 08/20/2009; Expert Rev Resp Med. 2009;3(2):187-196. © 2009 Expert Reviews Ltd.Pulmonary arterial hypertension (PAH), a common complication of systemic sclerosis, carries a very severe prognosis and is one of the leading...

» New Formulation of PAH Medication Is Now Available

Epoprostenol for Injection, an improved formulation of epoprostenol that is stable at room temperature, is now commercially available, according to the drug's maker, Actelion Pharmaceuticals US, Inc., of South San Francisco, Calif.The product is...

» Survival in Pulmonary Hypertension Associated With the Scleroderma Spectrum of Diseases

Stephen C. Mathai, Laura K. Hummers, Hunter C. Champion, Fredrick M. Wigley, Ari Zaiman, Paul M. Hassoun, and Reda E. GirgisObjective. Pulmonary hypertension (PH) is an important cause of mortality in systemic sclerosis (SSc), where it can be...

Add comment

Do feel free to leave your comments, as they would add value and knowledge to the community. However, please refrain from making any disparaging, uninformed, or unrelated comments. Thanks :)

Security code
Refresh