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 :

» New Genetic Path Targeted For Scleroderma Therapy

A genetic pathway previously known for its role in embryonic development and cancer has been identified as a target for systemic sclerosis, or scleroderma, therapy. The finding, discovered by a cross-disciplinary team led by John Varga, MD, John and...

» 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...

» Endothelin Drugs Benefit Those With Pulmonary Hypertension

Breaking news from has reported that recent research to block the effects of endothelin, a powerful substance that constricts blood vessels and stimulates cell growth, has led to successful treatment of and provides hope for treating other chronic...

» Cancer Drug May Also Work for Scleroderma

A drug used to treat cancer may also be effective in diseases that cause scarring of the internal organs or skin, such as pulmonary fibrosis or Scleroderma.The drug, with the generic name bortezomib, stopped the production of fibrotic proteins in...

» Xerostomia one of the Sjögren’s Syndrome Symptoms

“The American Health Institute spent $8 million for a research diagnosis of Sjögren syndrome in several countries as an important disease with high impact on society,” he told The Capital Dr. Ricardo Bazet, ophthalmologist, director of Rosario...

» Enhanced Survival Found With Early Detection of Scleroderma-Associated PAH

Early detection of incident systemic sclerosis–associated enhanced survival in a prospective cohort study of 131 patients from the multicenter PHAROS, according to data presented at the annual meeting of the American College of Rheumatology.The...