Swiss biopharmaceutical company Actelion Ltd (ALIOF.PK) on Monday said an exploratory phase II study with macitentan in patients with idiopathic pulmonary fibrosis or IPF did not meet its primary endpoint of forced vital capacity. The company added that the efficacy data is not supportive to initiate a Phase III study.
However, the MUSIC (Macitentan USe in an Idiopathic pulmonary fibrosis Clinical) study showed a promising long-term safety and tolerability profile of the drug.
The double-blind, randomized, placebo controlled, multicenter study evaluated the efficacy and safety of the 10 milligram dose of macitentan or placebo in 178 patients with IPF.
Pulmonary fibrosis is a progressive and usually fatal disease which may arise idiopathically or in association with underlying diseases like systemic sclerosis.
The company noted that no difference was being observed in the study between placebo and macitentan with regard to liver enzyme elevations.
Actelion added that it will analyze the study data in detail to understand certain observations in favor of macitentan such as reduced cough and fewer reported cases of pulmonary hypertension.
The company said it will present full study data through scientific publications, following discussions with clinical experts, and will decide on potential future exploratory efforts.
Macitentan is also currently being investigated in a Phase III study (SERAPHIN) designed to evaluate its safety and efficacy in patients with pulmonary arterial hypertension through the primary endpoint of morbidity and all-cause mortality.
Actelion Chief Executive Officer Jean-Paul Clozel said, "The 10 mg dose of macitentan is the higher of two doses under evaluation in our ongoing Phase III SERAPHIN study in pulmonary arterial hypertension. I expect this event-driven morbidity / mortality study with over 740 patients to report in the first half of 2012."
Actelion is currently trading at 32.94 Swiss Francs in Zurich, up 0.44 francs or 1.35 percent. In the U.S., the shares closed at $40.65 on Friday.
by RTT Staff Writer
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