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, Non-invasive Test May Help Diagnose Pulmonary Hypertension in Scleroderma

In patients with Systemic Sclerosis (SSc) – or – a condition called pulmonary hypertension (PH) is a leading cause of death. Having PH means the blood pressure between the heart and lungs is elevated.The Need for New Tests for PH in SScThe...

» Early Detection and Management of Pulmonary Arterial Hypertension

The long-term prognosis for patients with pulmonary arterial hypertension (PAH) remains poor, despite advances in treatment options that have been made in the past few decades. Recent evidence suggests that World Health Organization functional class...

» The Impact Of Art On Wellbeing In Autoimmune Disease

An innovative Newcastle research project is measuring the impact of creating art on the symptoms and overall wellbeing of people living with an autoimmune illness.A team at the University of Newcastle, in conjunction with the at John Hunter...

» Cell Therapy Yields Promising Results For Scleroderma Treatment

Cytori Therapeutics, Inc. provided preliminary data from a study evaluating a potential treatment for Scleroderma based on the company's cell therapy. The investigator-funded, open-label, pilot study is being conducted on patients with Cutaneous...

» arGentis Issued Key Patent Related to Treating Fibrosing Diseases by Induction of Immune Tolerance

arGentis Pharmaceuticals, LLC today announced the issuance of United States patent 7,718,765, entitled “Methods for Treating Fibrosing Diseases by Induction of Immune Tolerance." The issued patent, based on the seminal research of Arnold E....

» Lower Extremity Ulcers in Systemic Sclerosis: Features and Response to Therapy

Victoria K. Shanmugam, MBBS, MRCP; Patricia Price, PhD; Christopher E. Attinger, MD; Virginia D. Steen, MD Non-digital lower extremity ulcers are a difficult to treat complication of scleroderma that is often refractory to therapy. They are a...