Late Breaking Abstract - ELEVATE IPF phase 2b open-label extension demonstrates durable efficacy of deupirfenidone

<bold>Background:</bold> Deupirfenidone (DPF) is a deuterated form of pirfenidone with similar pharmacodynamic effects but differentiated pharmacokinetic profile, allowing for improved efficacy and tolerability in patients with idiopathic pulmonary fibrosis (IPF). <bold>Methods:</bold> Patients completing a phase 2b, randomized-controlled (RCT) trial of DPF 550 mg TID and DPF 825 mg TID compared to placebo and pirfenidone 801 mg TID for 26 weeks were continued/assigned to either DPF 550 mg or DPF 825 mg TID open label extension (OLE). Forced vital capacity (mL) data of patients who were randomized in DPF arms, and continued in OLE to complete 52 weeks were analyzed utilizing a mixed model for repeated measures, treating time as a continuous variable. <bold>Results:</bold> In RCT, 257 patients were randomly assigned 1:1:1:1. In OLE, completion rates to 52 weeks were 88.1% (37/42) and 87.2% (34/39) for DPF 825 mg and 550 mg arms. In RCT, changes in FVC for the 550 mg and 825 mg arms were -80.7 mL (95% confidence interval (CI), -138.3, -23.1), and -21.5 mL (95% CI, -78.2, 35.1), respectively. Over 52 weeks, changes in FVC were -147.0 mL (95% CI -223.5, -70.4) and -32.8 mL (95% (CI) -107.4, 41.7) for 550 mg and 825 mg arms. The most common adverse events (AE) for 550 mg were dyspepsia (7) and upper respiratory infections (URI) (6) and for 825 mg was URI (8). <bold>Conclusions:</bold> The ongoing OLE demonstrates that DPF 825 mg TID preserves lung function over 52 weeks in patients with IPF. <fig><object-id>erj;66/suppl_69/OA4456/F1</object-id><object-id>F1</object-id><object-id>F1</object-id><graphic></graphic></fig>