
Shares of Switzerland-based Actelion (SIX: ATLN), Europe’s largest biotech firm, gained 15.1% to 104.70 Swiss francs in early afternoon trading today, after the company revealed top-line results of the pivotal Phase III GRIPHON study in 1,156 patients with pulmonary arterial hypertension (PAH) with selexipag, the first selective oral prostacyclin IP receptor agonist.
Initial analysis shows that the event-driven outcome study has met its primary efficacy endpoint with high statistical significance. Selexipag decreased the risk of a morbidity/mortality event versus placebo by 39% (p<0.0001). Efficacy observed was consistent across the key subgroups; age, gender, WHO Functional Class, PAH etiology and background PAH therapy. Patients were treated for up to 4.3 years. The overall tolerability profile of selexipag in GRIPHON was consistent with prostacyclin therapies.
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