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 :

» 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...

» Study Indicates Scleroderma Mortality Rates Being Underestimated

patients have a significantly reduced life expectancy that is most likely being underestimated, delegates have heard. Most studies on scleroderma survival are based on prevalent cohorts, where no limit is placed on disease duration at the time of...

» When Our Antibodies Turn On Us

More than 32 million Americans harbor potentially toxic proteins that can attack body tissues and lead to autoimmune diseases such as Lupus and , according to a new study. This is the first accurate estimate of the frequency of the proteins, called...

» 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...

» Pulsed High-Dose Corticosteroids Combined With Low-Dose Methotrexate in Severe Localized Scleroderma

Alexander Kreuter, MD; Thilo Gambichler, MD; Frank Breuckmann, MD; Sebastian Rotterdam, MD; Marcus Freitag, MD; Markus Stuecker, MD; Klaus Hoffmann, MD; Peter Altmeyer, MDArch Dermatol. 2005;141:847-852Objective: To evaluate the efficacy of pulsed...

» Pulmonary Arterial Hypertension: Bridging The Present To The Future

The past decade has witnessed extensive progress in basic and clinical research in the field of pulmonary hypertension (PH), a group of chronic conditions characterised by high pressure in the pulmonary circulation. National and international PH...