Efficacy, Safety, and Tolerability of GLPG1205 for Idiopathic Pulmonary Fibrosis Treatment

Idiopathic pulmonary fibrosis (IPF) is a severe lung disease that affects the tissue surrounding the air sacs in the lungs. It causes the lung tissue to become thickened and scarred, making it hard for the lungs to work correctly. This results in breathing difficulties and reduced oxygen levels in the body. The exact cause of pulmonary fibrosis is often unknown (idiopathic), but it can be linked to certain environmental exposures, genetics, and autoimmune disorders. Unfortunately, there is no cure for pulmonary fibrosis, but treatments like medication and oxygen therapy can help manage symptoms and improve the patient's quality of life.

Clinical Trial

GLPG1205 is a selective functional antagonist of G-protein-coupled receptor 84 (GPR84). GPR84 plays a crucial role in fibrotic processes, making it an attractive target for IPF treatment. The PINTA trial was conducted to assess the efficacy, safety, and tolerability of GLPG1205 for IPF. The PINTA trial was a phase 2, randomized, double-blind, placebo-controlled, proof-of-concept study.

Sixty-eight patients diagnosed with IPF participated in the trial. They were randomly divided into two groups, with two-thirds receiving once-daily oral GLPG1205 at a dosage of 100 mg and the remaining third receiving a placebo for 26 weeks. Additionally, the patients were stratified to receive GLPG1205 either as a monotherapy or in combination with other standard-of-care treatments for IPF, such as nintedanib or pirfenidone.

The study's primary endpoint was to measure the change from baseline in forced vital capacity (FVC), which is a critical measure of lung function. Secondary endpoints included safety and tolerability assessments and measurements of lung volumes using high-resolution computed tomography (HRCT) imaging.

Results

GLPG1205 did not demonstrate a significant difference in FVC decline compared to the placebo. Both groups showed a decrease in lung function over 26 weeks. Treatment with GLPG1205 was associated with a poorer safety and tolerability profile compared to the placebo. Patients receiving GLPG1205 experienced a higher proportion of severe treatment-emergent adverse events, leading to more treatment-emergent discontinuations, particularly when combined with nintedanib.

Conclusion

While the results of the PINTA trial were disappointing, it is essential to recognize that clinical research is an iterative process. Not all trials yield positive outcomes, and these findings will provide valuable insights for future research on IPF treatments. As scientists continue to unravel the complexities of IPF, new therapeutic targets may emerge, offering hope for improved outcomes and enhanced quality of life for individuals living with this challenging lung disease.
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