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 :

» PUVA Therapy In The Treatment of Localized Scleroderma

In localized , disease activity would tend to stop spontaneously over time. Treatment is important to reduce disabilities caused by the active phases of disease. According to , there are three treatments used in the treatment of localized...

» Preterm Delivery a Risk in Systemic Sclerosis

Many women with systemic sclerosis can have successful pregnancies, but the rates of preterm birth, low birth weight, and intrauterine growth restriction are approximately twice as high in these women compared to the general population of pregnant...

» Methotrexate Effective In Juvenile Localized Scleroderma

is effective in when given with a short course of steroids, an Italian randomized study confirmed.Among children ages 6 to 17 receiving methotrexate, 67.4% completed the yearlong trial without flaring, compared with 29.2% of those given placebo...

» The Heart In Scleroderma

Just as can affect multiple organ systems, the cardiac manifestations of the disease are diverse. Although only relatively recently recognized, the heart is a major organ involved in Scleroderma and the presence of cardiac involvement generally...

» Scientists and Clinicians Address Diagnosis and Treatment for Autoimmune and Autoinflammatory Diseases

Autoimmune and autoinflammatory diseases are a major health issue. The National Institutes of Health reports that up to 23.5 million Americans are afflicted. The American Autoimmune Related Diseases Association reports the number is closer to 50...

» Is Pulmonary Arterial Hypertension Really a Late Complication of Systemic Sclerosis?

Eric Hachulla, MD, PhD; David Launay, MD, PhD; Luc Mouthon, MD, PhD; Olivier Sitbon, MD, PhD; Alice Berezne, MD; Loïc Guillevin, MD; Pierre-Yves Hatron, MD; Ge´rald Simonneau, MD; Pierre Clerson, MD; and Marc Humbert, MD, PhD;Pulmonary arterial...