GLPG1690 is a selective autotaxin inhibitor discovered by Galapagos and aimed at idiopathic pulmonary disease (IPF). In the FLORA Phase 2a study in IPF patients, Galapagos reported a halt in disease progression, target engagement, and favorable safety and tolerability.
In April 2018, Galapagos announced the design of a worldwide Phase 3 program to evaluate GLPG1690 in patients with idiopathic pulmonary fibrosis. 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.
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.
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