Galapagos reports positive topline results with GLPG1205 in IPF patients in PINTA Proof-of-Concept trial
- Placebo-adjusted improvement in forced vital capacity (FVC) decline of 42mL across treatment groups at 26 weeks
- Correlation between FVC decline and pulmonary lobar volume change observed, as measured by functional respiratory imaging (FRI)
- GLPG1205 planned to progress to dose finding Phase 2b study
Mechelen, Belgium; 30 November 2020, 22.01 CET; Galapagos NV (Euronext & NASDAQ: GLPG) announces positive topline results with its investigational GPR84 antagonist GLPG1205 in Proof-of-Concept Phase 2 trial in idiopathic pulmonary fibrosis (IPF) patients.
The PINTA trial was a randomized, double-blind, placebo-controlled trial investigating a 100mg once-daily oral dose of GLPG1205. The study recruited and included a total of 68 IPF patients. Participants were administered drug candidate or placebo (2:1 randomization) for 26 weeks and could remain on their standard of care as background therapy, i.e. nintedanib, pirfenidone or neither. The primary objective of the trial was to assess the change from baseline in FVC (in mL) over 26 weeks compared to placebo. Other measures included safety, tolerability, time to major events, changes in functional exercise capacity, quality of life, pharmacokinetics, pharmacodynamics and FRI.
At week 26, patients receiving GLPG1205 on top of standard of care showed a smaller FVC decline, with a difference of 42mL versus placebo on top of standard of care (-76mL on placebo; -34mL on treatment). The study was not powered to show statistical significance. The FVC trend was consistent across the three treatment strata. In addition, the change in pulmonary lobar volume, as measured by FRI, correlates with the FVC decline observed.
No relevant safety signals were observed for GLPG1205 alone and on top of pirfenidone. The most frequently reported adverse events on GLPG1205 alone were gastrointestinal disorders, especially nausea. In the treatment arm of GLPG1205 on top of nintedanib, a higher rate of early discontinuations and high grade TEAEs were observed. In the arm of the study with GPLG1205 on top of nintedanib, there was one death due to an exacerbation of IPF, which was determined to be unrelated to study treatment.
Based on the results of this trial, Galapagos plans to progress GLPG1205 in a dose finding Phase 2b trial.
The full results of the PINTA trial will be submitted to a future medical conference and peer-reviewed medical journals.
“Keeping in mind the limitations of this early clinical study, the PINTA study with GLPG1205 is a positive trial. The consistent changes observed across treatment strata, using different analytical methods, including FRI, are very encouraging. While we need to understand more about long-term tolerability of the drug, the PINTA results warrant further investigation,” said Prof. Dr. Toby Maher, Professor of Medicine at Keck School of Medicine, University of Southern California.