Actelion wins positive review for Phase III pulmonary fibrosis study

Swiss biopharmaceutical company Actelion has reported that the Independent Data and Safety Monitoring Board or DSMB has recommended continuation of the pivotal Phase III study BUILD-3, evaluating the efficacy and safety of bosentan in patients suffering from idiopathic pulmonary fibrosis.

The DSMB was mandated to perform an efficacy and futility interim analysis of 75% of events in BUILD-3 to assess whether study continuation is warranted based on the primary objective of demonstrating delayed disease worsening or death. Final study results are expected before the end of 2009.

BUILD-3 is a multicenter, double-blind, randomized, placebo-controlled, parallel group, event-driven morbidity/mortality study evaluating the safety and efficacy of bosentan 125mg bid in idiopathic pulmonary fibrosis patients. BUILD-3 enrollment was completed in November 2008 with 616 patients.

The study is randomized with two bosentan patients to one placebo patient and is planned to reach 202 events. Following the second interim analysis (75% of events) by an independent DSMB, the study continues as planned. BUILD-3 is conducted under a standard protocol assessment with the FDA.

Actelion, a biopharmaceutical company focused on the discovery, development and marketing of innovative drugs for significant unmet medical needs. Actelion’s first drug Tracleer, is marketed worldwide, including the United States (based in South San Francisco), the European Union, Japan, Canada, Australia and Switzerland.