Where do we go from here? Clinical drug development in idiopathic pulmonary fibrosis.

Despite the recent success of the nintedanib and pirfenidone programmes [1, 2], idiopathic pulmonary fibrosis (IPF) remains a high-risk disease area for drug development. There are no adequate preclinical models in which to test potential compounds, and no established early clinical development pathway on which to make quick decisions regarding potential efficacy [3]. The historical approach in IPF of moving compounds directly from phase 1 safety and tolerability studies into large phase 2 studies with clinical end-points required major commitments from sponsors and research subjects. Now, with effective therapies reducing the frequency and responsiveness of clinical end-points, sponsors may decide that IPF is too costly a disease to invest in.