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news.Gilead Sciences has initiated Athena-1, a Phase IV, randomized, double-blind, placebo-controlled study evaluating Letairis in patients with pulmonary arterial hypertension demonstrating a sub-optimal response to sildenafil monotherapy.
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Athena-1 is the first of several Phase IV Letairis (ambrisentan 5mg and 10mg tablets) studies Gilead plans to initiate in 2008 and 2009. Letairis is currently approved as a once-daily treatment for pulmonary arterial hypertension (PAH) (WHO Group 1) in patients with WHO functional class II or III symptoms to improve exercise capacity and delay clinical worsening.
Norbert Bischofberger, executive vice president of R&D and chief scientific officer at Gilead, said: “The PAH research community has made great progress over the last several decades in developing therapies for patients, including establishing an understanding of the role of therapies targeting different disease pathways. With our Phase IV program, we hope to contribute to the growing body of knowledge about this disease.”