Actelion reports new study justifies further investigation of bosentan

New York, May 23 - Actelion Ltd. said new data indicates further investigation into the safety and efficacy of bosentan is justified.

Findings from the Build program (Bosentan Use in Interstitial Lung Disease) presented at the American Thoracic Society conference showed benefits for time to death and disease progression in patients suffering from idiopathic pulmonary fibrosis.

Morbidity and mortality were secondary endpoints of the phase 3 study.

As previously communicated in November 2005, bosentan did not have a positive effect on the six-minute walk test, which was the primary endpoint of the research, but treatment with bosentan showed a positive trend for pre-defined morbidity/mortality endpoints.

The combined incidence of disease progression or death up to 12 months was 36.1% in the placebo group versus 22.5% in the bosentan group, representing a relative risk reduction of 38%.

Actelion said a new and full analysis of the study was presented at the American Thoracic Society, included evaluation of the treatment effect of bosentan in patients who had lung biopsy as a proof of idiopathic pulmonary fibrosis. The analysis of this patient group, which was considered of special interest by the Food and Drug Administraiton, showed a significantly more pronounced treatment effect.

In these patients, the combined incidence of disease progression or death up to 12 months was 38.0% in the placebo group versus 12.2% in the bosentan group, representing a relative risk reduction of 68%.

The use of bosentan in the study was well tolerated with no unexpected adverse events.

"The unexpected and very encouraging Build-1 findings in lung-biopsy proven IPF [idiopathic pulmonary fibrosis] definitely warrant further clinical evaluation of bosentan in this indication," said Talmadge King Jr., professor of medicine at UCSF, San Francisco General Hospital and principal investigator of the Build-1 study, in a news release. "I am also encouraged to see that bosentan had a positive effect on the morbidity/mortality endpoint, mostly comprised of pulmonary function tests, which is a clinically important and robust endpoint."

Actelion said it is currently in advanced discussion with regulatory authorities to finalize the design and scope of a phase 3 mortality and morbidity study in patients with biopsy proven idiopathic pulmonary fibrosis. Enrollment is expected to start by the end of the year.

Actelion is a Basel, Switzerland-based biopharmaceutical company.

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