Design of phase 2 study of TAS-115, a novel oral multi-kinase inhibitor, in patients with idiopathic pulmonary fibrosis

Abstract

BackgroundTAS-115, a novel multi-kinase inhibitor, demonstrated antifibrotic effects in vitro and in vivo. MethodsThis is an open-label, intra-patient comparison, exploratory phase 2 study of TAS-115 to evaluate the efficacy and safety in idiopathic pulmonary fibrosis (IPF) patients when orally administered at 200 mg once daily on a 5-day on and 2-day off regimen for 13 weeks. This study consists of three cohorts: previously treated with pirfenidone (Cohort P, n = 20), with nintedanib (Cohort N, n = 20), and treatment naïve (Cohort U, n = 10). Male or female patients aged ≥40 to <80 years who were diagnosed with IPF in the preceding five years and having a percent predicted forced vital capacity (%FVC) decline of ≥5% within the previous 6 months were enrolled in this study. The primary endpoint is change in the slope of %FVC decline at Week 13 from baseline. Key secondary endpoints are safety, change in FVC from baseline, proportion of the %FVC responders and change in percent predicted diffusing capacity of the lung carbon monoxide from baseline, which are assessed at Weeks 6, 13 and 26. ResultsEnrollment of 45 patients was completed in July 2019. Results will be reported in 2021. DiscussionThis trial is intended to demonstrate the clinical efficacy of TAS-115 in IPF patients who have not responded to pirfenidone or nintedanib, as well as in those who are pirfenidone/nintedanib treatment naïve. The safety and tolerability in this population will be assessed. Trial registrationJapicCTI-183898.