GLPG1205 shows reduction in lung volume decline over 26 weeks vs placebo when measured with novel volumetric CT analysis in IPF patients

The PINTA trial (NCT03725852) was a double-blind placebo (PBO)-controlled study of GLPG1205 in 68 IPF patients. At 26 weeks, patients randomised to GLPG1205 showed a numerically smaller decline in FVC (primary outcome). We explored use of automated CT analysis as an alternative endpoint. CT scans were uploaded to the Qureight platform to allow real-time quantification and longitudinal assessment of change in lung (LUNG8) and airway (AIR8) volumes.1 43 patients with at least two scans 26 weeks apart were included for analysis. After quality control, 42 were suitable for LUNG8 and 41 for AIR8. Statistical analysis was performed with python, power analysis with R-package Superpower. A significant difference in lung volume change over 26 weeks was found (GLPG1205=+1.51% vs PBO=–4.48%, p=0.027). There was no significant difference in standardised airway volume change between groups (GLPG1205=–0.57% vs PBO=0.26%, p=0.85), Fig 1. The estimated effect size in lung volume (0.71) implies that n=36 per group is sufficient to achieve 80% power. Our data further support that GLPG1205 slows reduction in lung volume over time compared to PBO in IPF. Novel imaging quantification software may provide alternative trial endpoints allowing for smaller trial sizes. These will require standardised imaging protocols and power calculations. 1. Roberts M. ERS 2021, OA3951 Funding: Galapagos, Qureight