) recently announced that it will initiate a phase III
development program with its clostridium difficile-associated
diarrhea (CDAD) candidate, cadazolid.
The multi-center, randomized, double-blind studies will
evaluate the safety and efficacy of cadazolid (250 mg,
administered orally, twice daily) as compared to
) Vancocin (125 mg, administered orally, four times daily) in
CDAD patients for 10 days.
This program comprises two similar studies which will evaluate
whether the clinical response of cadazolid is non-inferior to
Vancocin in CDAD patients and whether administration of cadazolid
is superior to Vancocin in sustained clinical response. Enrolment
of 1250 patients globally for the program is expected to start at
the end of 2013.
The decision to advance the candidate into late-stage
development was based on an exploratory phase II dose-finding
study. Cadazolid was studied in a phase II multi-center,
double-blind, randomized, active reference, parallel group,
therapeutic exploratory study. Three doses of cadazolid
(administered orally, twice daily) were evaluated for efficacy,
safety and tolerability for 10 days with Vancocin as an active
reference (125 mg administered orally, four times daily).
Results showed that the effect of all doses of cadazolid were
either numerically similar or better than Vancocin on primary
endpoints, which included CDAD cure rates as well as sustained
Earlier this month, Actelion was in the news when it presented
encouraging efficacy data on its pulmonary arterial hypertension
(PAH) candidate, Opsumit at the European Society of Cardiology
from a pivotal phase III study, SERAPHIN.
Actelion currently carries a Zacks Rank #1 (Strong Buy). Other
stocks that look equally attractive in the pharma space include
Biogen Idec Inc
AFFYMETRIX INC (AFFX): Free Stock Analysis
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