On 30 November, Galapagos reported positive topline results from its Phase IIA PINTA clinical trial investigating the use of 100mg GLPG1205 for the treatment of idiopathic pulmonary fibrosis (IPF).
The 26-week study was conducted in 68 randomised patients and demonstrated that the GLPG1205 treatment arm had a smaller decline in forced vital capacity (FVC). Notably, this study was not powered to show statistical significance. GLPG1205 is an oral GPR84 inhibitor that has shown favourable efficacy in IPF animal models and safety in healthy volunteers. Additionally, the PINTA study was conducted accounting for patients on the current standards of care. Though this is a promising result in a disease with high unmet clinical need, the real test for the drug will come in the form of larger trials and subsequent statistical evaluation.
Per the company statement, Galapagos will be undertaking a Phase IIB dose-ranging study based on these study results. However, the IPF disease space has been challenging for drug developers for several reasons. Many promising candidates were based on animal model data (the bleomycin mouse model) but have not shown sufficient efficacy in subsequent human clinical trials, highlighting a key challenge facing pharmaceutical companies in IPF: imperfect animal models do not accurately represent human disease, leading to a high failure rate for drug development. In some cases, the efficacy seen in pre-clinical animal studies has yet to translate to human subjects. Additionally, other well-known immunology therapies, such as Enbrel (entanercept), have not shown efficacy in IPF patients.
Of the manufacturers hoping to enter the IPF disease though, Galapagos is in a strong position as the company has another agent in development for IPF. GLPG1690/ziritaxestat is an oral autotaxin inhibitor being jointly developed by Gilead and Galapagos and is expected to be one of the first pipeline agents launched in the next five to ten years. Moving forward, being able to demonstrate GLPG1205’s efficacy as a monotherapy or in combination with standard care will be hugely instrumental in distinguishing Galapagos’ position as a leader in the IPF disease space.