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 :

» Biomarkers Predict Lung Decline in Systemic Sclerosis

Predicting risk of pulmonary fibrosis and pulmonary hypertension is an urgent priority in systemic sclerosis. Lung function often declines rapidly in the first years after diagnosis, and interstitial lung disease (ILD), although highly variable in...

» Scientists Identify Agent That Can Block Fibrosis of the Skin and Lungs

Researchers at the have identified an agent that in lab tests protected the skin and lungs from fibrosis, a process that can ultimately end in organ failure and even death because the damaged tissue becomes scarred and can no longer function...

» November Is Pulmonary Hypertension Awareness Month

November is Pulmonary Hypertension Awareness Month. Pulmonary hypertension means increased blood pressure in the blood vessels in the lungs. This can cause shortness of breath, extreme tiredness, fainting, or dizziness, and can lead to more severe...

» Scleroderma Patients At Greater Risk Of Myocardial Infarction Within First Year

According to the first large population-based cohort study of its kind, patients with Systemic Sclerosis or were found to be at a greater than eightfold increased risk of having an acute (MI) during their first year after diagnosis. After that...

» Long-Term Outcomes of Scleroderma Renal Crisis

In a previous study. researchers sought to describe the medical history of a group of patients with Scleroderma Renal Crisis who had been treated with ACE inhibitors. The following is essentially a summary of that study, which was conducted by...

» Systemic Sclerosis Patients Treated With Oral Treprostinil Diethanolamine

Patients with effectively absorbed oral treprostinil diethanolamine, which produced a temporal association with improved cutaneous perfusion and temperature, according to study results. In a dual-center, open-label, phase 1 study, researchers...