Phase 3 study of ambrisentan terminated for idiopathic pulmonary fibrosis (IPF)
Gilead Sciences announced it is stopping ARTEMIS-IPF, the company's ongoing Phase 3 clinical trial of ambrisentan in patients with idiopathic pulmonary fibrosis (IPF), due to lack of efficacy. This decision follows an interim analysis of unblinded efficacy and safety data by the study's Data Monitoring Committee (DMC) and review of those data by Gilead, which did not show evidence of a treatment benefit in the group of patients randomized to receive ambrisentan.
Ambrisentan is an endothelin receptor antagonist that is selective for the endothelin type-A (ETA) receptor. Activation of the ETA receptor by endothelin, a small peptide hormone, leads to vasoconstriction (narrowing of blood vessels) and cell proliferation. It is currently marketed (as Letairis) and approved in the U.S. for the treatment of pulmonary arterial hypertension (WHO Group 1) in patients with WHO class II or III symptoms to improve exercise capacity and delay clinical worsening.
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