ALLSCHWIL/BASEL, SWITZERLAND – 12 January 2015 - Actelion Ltd (SIX: ATLN) announced today that Jean-Paul Clozel, Chief Executive Officer of Actelion, will present at the J. P. Morgan Healthcare Conference on January 13, 2015 at 08:00 AM Pacific Standard Time / 17:00 Hrs Central European Time at the Westin St. Francis Hotel in San Francisco, CA.
ALLSCHWIL/BASEL, SWITZERLAND – 17 March 2014 – Actelion Ltd (SIX: ATLN) today announced the results of COMPASS-2, a Phase IV, prospective, randomized, double-blind, placebo-controlled, event-driven study evaluating the effect of bosentan on the time to first morbidity or mortality event in patients with symptomatic pulmonary arterial hypertension (PAH) already treated with sildenafil.
COMPASS-2 did not meet the primary endpoint of time to first morbidity or mortality event; bosentan showed a risk reduction of 17% versus placebo (p=0.25). In an exploratory analysis, bosentan on top of sildenafil showed an improvement of 21.8 meters in 6MWD at week 16 (p=0.01). The well characterized safety profile of bosentan was confirmed and a placebo-corrected incidence of 15.4% in liver enzyme elevations (aspartate aminotransferase (AST) or alanine aminotransferase (ALT)) greater than three times the upper limit of normal was observed over a median exposure to double-blind treatment of 23 months.
Vallerie McLaughlin MD, University of Michigan, Ann Arbor, US, Chair of the COMPASS-2 Steering Committee commented; “While the observed risk reduction of 17% did not reach statistical significance, I am convinced that this study provides important information for the scientific community and we are committed to perform all the necessary analyses to fully understand the outcome of the study.”
Alessandro Maresta MD, Vice President, Head of Global Medical Affairs, Actelion commented; “The completion of the COMPASS-2 study has been a significant effort in a changing PAH environment and shows our commitment to ongoing clinical research in PAH. We acknowledge that taking part in research is one of the most important ways to advance scientific knowledge, and we thank the investigators, their staff and all the patients for their participation in this long-term study.”
Full data from this study will be made available through scientific disclosure at upcoming congresses and peer-reviewed publications