09 Dec 2020
Posted in Pharma
Galapagos Phase IIA PINTA IPF topline study results are cause for cautious optimism
Galapagos recently reported positive topline results from its Phase IIA PINTA clinical trial investigating the use of 100 mg GLPG1205 for the treatment of idiopathic pulmonary fibrosis (IPF). Although the trial had 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, according to GlobalData a leading data and analytics company.
The 26-week study was conducted in 68 randomized 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 favorable efficacy in IPF animal models and safety in healthy volunteers.
Tiffany Chan, Immunology Analyst at GlobalData, explains: “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.”
This highlights 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.
Chan adds: “Per the company statement, Galapagos will be undertaking a Phase IIB dose ranging study based on these study results. Of the manufacturers hoping to enter the IPF disease though, these results place Galapagos in a strong position as they also have 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 of care will be hugely instrumental in distinguishing Galapagos’ position as a leader in the IPF disease space.”