Actelion Ltd. (ALIOF) announced top-line data from the randomized, multi-center, double-blind, placebo-controlled phase III GRIPHON study (n=1,156) on selexipag for pulmonary arterial hypertension (PAH). The candidate met the primary efficacy endpoint with high statistical significance. Selexipag was well tolerated in the patients.
This study showed that treatment with selexipag (dosage increment from 200 mcg to 1600 mcg twice daily) reduced the risk of a morbidity/mortality event by 39% compared to placebo. The efficacy profile of the candidate was consistent across five key patient subgroups − age, gender, WHO Functional Class, PAH etiology and background PAH therapy.
In this study, the company used individualized uptitration of selexipag (the maintenance dose of selexipag to be decided based on the patient’s tolerability). The process was successful and a consistent result was achieved across the entire dose range.
Meanwhile, Actelion is working on strengthening its pipeline. The company has another candidate, cadazolid, in phase III study. Actelion is developing cadazolid for the treatment of clostridium difficile associated diarrhea (:CDAD). Results from the cadazolid study should be out by early 2016. Cadazolid has Qualified Infectious Disease Product (:QIDP) designation in the U.S. along with fast track status.
Some drugs approved for the treatment of PAH are Bayer’s (BAYRY) Adempas and Gilead’s (GILD) Letairis.
We are encouraged by the positive data on selexipag in the pivotal study. The successful development of selexipag will further strengthen Actelion’s PAH franchise.
Actelion carries a Zacks Rank #3 (Hold). A better-ranked stock in the health care sector is ANI Pharmaceuticals, Inc. (ANIP) carrying a Zacks Rank #1 (Strong Buy). Gilead also carries a Zacks Rank #1.