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ALIOF Drug to Move into Phase III - Analyst Blog
12/26/2012 1:02:00 PM
Actelion ( ALIOF ) recently announced that it is moving forward with phase III development of cadazolid in patients suffering from clostridium difficile associated diarrhea (CDAD).
The decision comes after an exploratory phase II dose-finding study was conducted. 3 doses of cadazolid (administered orally, twice-daily) were evaluated for efficacy, safety and tolerability for 10 days with ViroPharma's Vancocin (vancomycin) 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 cure rates.
The study also found that recurrence rates (a new episode of diarrhea and a positive clostridium difficile toxin test) were numerically lower for all doses of cadazolid versus Vancocin.
With these encouraging results in hand, Actelion is now moving ahead with a phase III program for this new class of antibiotics. The company intends to meet with health authorities to discuss the details of the phase III program.
Meanwhile, competition will be stiff for cadazolid. While ViroPharma already sells branded and authorized generic versions of Vancocin in the US and its territories, Optimer Pharmaceuticals' ( OPTR ) Dificid gained US Food and Drug Administration (FDA) approval in May 2011. Dificid was launched last year.
Nevertheless, we are impressed with Actelion's recent progress with its pipeline. Last week, Actelion announced positive results from a phase II study on its S1P1 modulator, ponesimod. Actelion is evaluating ponesimod as a treatment for patients suffering from moderate-to-severe chronic plaque psoriasis.
In addition, the FDA accepted Actelion's New Drug Application (NDA) for macitentan. Actelion is looking to get macitentan approved in the US as a treatment for patients suffering from pulmonary arterial hypertension (PAH).
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