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Idiopathic pulmonary disease

Galapagos is committed to establishing itself as valued scientific partner in the race to combat idiopathic pulmonary fibrosis (IPF). We have growing pipeline of new molecules with distinct mode of action which are moving rapidly in clinical development. Our most advanced molecule GLPG1690 is an oral, once daily autotaxin inhibitor for which we are preparing our first Phase 3 studies: the largest clinical program ever undertaken in IPF.

GLPG1690
In April 2018, we announced the design of this worldwide Phase 3 program to evaluate GLPG1690 in IPF patients. The planned ISABELA Phase 3 program with GLPG1690 is intended to support both New Drug Application (NDA) and Market Authorization Application (MAA) submissions in respectively the US and EU. It is expected that the ISABELA studies sponsored by Galapagos will start in the 2nd half of 2018. In the FLORA Phase 2a study in IPF patients, Galapagos reported a halt in disease progression, target engagement, and favorable safety and tolerability. GLPG1690 is fully proprietary to Galapagos and has been granted orphan status in Europe and the US. Preliminary information about the ISABELA studies to be found at www.isabelastudies.com.

GLPG1205

In July 2018, we announced the design for the PINTA Phase 2 trial with GLPG1205 in IPF.  First dosing of an IPF patient is expected in the second half of 2018. GLPG1205 is a GPR84 inhibitor discovered by Galapagos and fully proprietary to Galapagos. GLPG1205 showed a reduction in signs and symptoms in IPF animal models and has shown favorable tolerability in healthy volunteers and ulcerative colitis patients in previous trials.


Related publications

A randomized, placebo-controlled, double blind Phase IIaclinical trial to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of 12 weeks of treatment of an autotaxininhibitor (GLPG1690) in individuals with Idiopathic Pulmonary Fibrosis, ATS 2018

Assessment of the effects of GLPG1690 in idiopathic pulmonary disease (IPF) patients using functional respiratory imaging (FRI), ATS 2018

Pharmacodynamics and Pharmacokinetics of the Autotaxin Inhibitor GLPG1690 in the FLORA Trial: A Randomized, Placebo-Controlled, Double Blind Phase IIa Clinical Trial of 12 Weeks in Individuals, ATS 2018

Safety, tolerability, pharmacokinetics, and pharmacodynamics of GLPG1690, a novel autotaxin inhibitor, to treat idiopathic pulmonary fibrosis (FLORA): a phase 2a randomised placebo-controlled trial, The Lancet Respiratory Medicine, May 2018
 

Autotaxin Inhibitor GLPG1690 Affects TGFβ-induced Production of the Pro-Fibrotic Mediators CTGF, IL-6 and ET-1 in Fibroblasts, ATS 2017

Discovery of GLPG1690, a First-in-Class Autotaxin Inhibitor Undergoing Clinical Evaluation for the Treatment of Idiopathic Pulmonary Fibrosis, Journal of Medical Chemistry, April 2017

Strong reversal of the lung fibrosis disease signature by autotaxin inhibitor GLPG1690 in a mouse model for IPF, ERS 2016

 Favorable human safety, PK/PD of the autotaxin inhibitor GLPG1690, a potential new treatment in IPF, ATS 2016

 Pharmacological profile and efficacy of GLPG1690, a novel autotaxin inhibitor for the treatment of IPF, ATS 2016

Discovery of GLPG1690: a first-in-class autotaxininhibitor in clinical development for the treatment of IPF at 251st American Chemical Society National Meeting 2016

Poster on pre-clinical data with GLPG1690 at ERS 2015

Oral presentation on pre-clinical data with GLPG1690 at ERS 2015