GLPG1205 for idiopathic pulmonary fibrosis: a phase 2 randomised placebo-controlled trial.

Abstract

BACKGROUND:

GLPG1205 is a selective functional antagonist of G-protein-coupled receptor 84, which plays an important role in fibrotic processes. This study assessed the efficacy, safety and tolerability of GLPG1205 for treatment of idiopathic pulmonary fibrosis (IPF).

METHODS:

PINTA (ClinicalTrials.gov: NCT03725852) was a phase 2, randomised, double-blind, placebo-controlled, proof-of-concept trial. Patients with IPF were randomised 2:1 to once-daily oral GLPG1205 100 mg or placebo for 26 weeks and stratified to receive GLPG1205 alone or with local standard of care (nintedanib or pirfenidone). The primary end-point was change from baseline in forced vital capacity (FVC); other end-points were safety and tolerability, and lung volumes measured by imaging (high-resolution computed tomography). The study was not powered for statistical significance.

RESULTS:

In total, 68 patients received study medication. Least squares mean change from baseline in FVC at week 26 was -33.68 (95% CI -112.0-44.68) mL with GLPG1205 and -76.00 (95% CI -170.7-18.71) mL with placebo (least squares mean difference 42.33 (95% CI -81.84-166.5) mL; p=0.50). Lung volumes by imaging declined -58.30 versus -262.72 mL (whole lung) and -33.68 versus -135.48 mL (lower lobes) with GLPG1205 versus placebo, respectively. Treatment with GLPG1205 versus placebo resulted in higher proportions of serious and severe treatment-emergent adverse events and treatment-emergent discontinuations, most apparent with nintedanib.

CONCLUSIONS:

Treatment with GLPG1205 did not result in a significant difference in FVC decline versus placebo. GLPG1205 demonstrated a poorer safety and tolerability profile than placebo.

• Authors: Irina R Strambu, Christian A Seemayer, Liesbeth M-C A Fagard, Paul A Ford, Tom A K Van der Aa, Angela A de Haas-Amatsaleh, Vikas Modgill, Eva Santermans, Eric N Sondag, Eric G Helmer, Toby M Maher, Ulrich Costabel, Vincent Cottin
• Journal: The European respiratory journal (Eur Respir J) Vol. 61 Issue 3 (03 2023) ISSN: 1399-3003 [Electronic] England
• PMID: 36328358 (Publication Type: Randomized Controlled Trial, Clinical Trial, Phase II, Journal Article, Research Support, Non-U.S. Gov't)
• Copyright: Copyright ©The authors 2023.

Chemical References

• GLPG1205

Topics

• Humans
• Idiopathic Pulmonary Fibrosis (drug therapy)
• Lung (diagnostic imaging)
• Vital Capacity
• Double-Blind Method
• Treatment Outcome