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.
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.
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.
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
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