Phase 4 Actelion Review Misses Major Endpoint

Actelion Actelion announced nowadays that a phase four review with its blockbuster drug bosentan (Tracleer) had failed to meet its main endpoint.

The COMPASS-2 trial was a prospective, randomized, double-blind, placebo-controlled trial evaluating the result of bosentan on the time to very first confirmed event in patients with symptomatic pulmonary arterial hypertension (PAH) previously receiving treatment with sildenafil.

According to the firm, a 17% danger reduction in the principal endpoint of the time to initial event did not reach statistical significance (p=.25). Actelion reported that an exploratory examination showed a significant increase in the 6 minute strolling distance in the mixture group and “and a placebo-corrected incidence of 15.four%” in elevated liver enzymes above 23 months of treatment method.

The press release quoted the University of Michigan’s Vallerie McLaughlin, chair of the trial’s steering committee: “While the observed threat reduction of 17% did not reach statistical significance, I am convinced that this review supplies crucial data for the scientific local community and we are committed to execute all the needed analyses to totally comprehend the end result of the review.”

The company said that the total final results of the review will be presented at potential congresses and in peer-reviewed publications.

John Ryan, a pulmonary hypertension expert at the University of Utah, presented the following viewpoint:

“The COMPASS-2 trial assessed the efficacy of a common clinical practice, namely the addition of bosentan (an endothelia receptor antagonist, ERA) to sufferers with pulmonary arterial hypertension (PAH) already taking sildenafil (phosphodiesterase five inhibitor, PDE5i). The security and benefit (or otherwise) of this mixture treatment has been largely unknown. But because this illness process can advance so quickly with a limited life expectancy, if patients are deemed to be failing monotherapy with clinical deterioration, most PAH providers are aggressive in adding on a 2nd agent. For that reason the COMPASS-2 trial represents a marked advance in our information of the merits of dual treatment. Searching forward, it will be critical to complete similar combination trials with the other classes of agents accessible, especially ERAs and the new soluble guanylate cyclase stimulators (riociguat being the only currently available agent).”

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