Actelion's macitentan meets primary endpoint in pivotal Phase III study
Actelion announced that initial analysis indicates that the pivotal, long-term, event-driven study SERAPHIN with macitentan, a novel dual endothelin receptor antagonist, in 742 patients suffering from pulmonary arterial hypertension (PAH) and treated for up to three and a half years, has met its primary endpoint.
Macitentan, at both the 3 mg and 10 mg dose, decreased the risk of a morbidity/mortality event over the treatment period versus placebo. This risk was reduced by 45 percent in the 10 mg dose group (p<0.0001). At 3 mg, the observed risk reduction was 30 percent (p=0.0108). Treatment with macitentan in the SERAPHIN study was well tolerated.
Secondary efficacy endpoints, including change from baseline to month 6 in six-minute walk-distance, change from baseline to month 6 in WHO functional class and time - over the whole treatment period - to either death due to PAH or hospitalization due to PAH, also showed a dose-dependent effect (p<0.05 for either dose). A trend in favor of 10 mg macitentan was observed on all-cause mortality (p=ns).
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