Galapagos NV has announced the start of its exploratory Phase 2a study with GLPG1690 in idiopathic pulmonary fibrosis (IPF) patients, named FLORA. FLORA is a randomized, double-blind, placebo-controlled study investigating a once daily oral dose of GLPG1690 administered for 12 weeks in 24 IPF patients.
Primary objectives of the study are to assess safety, tolerability, pharmacokinetics and pharmacodynamics of GLPG1690 in an IPF patient population. Target engagement will be measured by LPA in plasma and bronchoalveolar lavage fluid, both at baseline and through twelve weeks of treatment.
Secondary objectives include the evaluation of lung function, changes in disease biomarkers and quality of life. Galapagos expects to complete patient recruitment before end 2016, and to report topline results in Q2 2017. GLPG1690 is a small molecule inhibitor of autotaxin and fully proprietary to Galapagos.
"We identified the autotaxin target using our proprietary target discovery platform and developed
molecule GLPG1690 as an inhibitor of this target. GLPG1690 shows promising results in relevant
pre-clinical models for IPF, and there is growing evidence in scientific literature that autotaxin plays a role in this disease.
We are pleased to be able to investigate the effect of GLPG1690 in IPF patients and look forward to seeing the results in the first half of next year,” said Dr Piet Wigerinck, Chief Scientific Officer of Galapagos.