) 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 (
) Adempas and
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.
) carrying a Zacks Rank #1 (Strong Buy). Gilead also carries a
Zacks Rank #1.
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