Galapagos, a clinical-stage biotech that specializes in the discovery and development of small molecule medicines with novel modes of action, recently initiated an exploratory Phase 2a clinical trial (FLORA) with its lead drug candidate GLPG1690 for the treatment of patients with idiopathic pulmonary fibrosis (IPF).
FLORA is a randomized, double-blind, placebo-controlled trial testing the tolerability, safety, pharmacodynamics, and pharmacokinetics of GLPG1690 in 24 patients with IPF for a treatment period of 12 weeks. The drug is given once daily orally.
GLPG1690 is a selective autotaxin inhibitor that was demonstrated in a Phase 1 study in healthy human volunteers to have a favorable safety and tolerability profile. Autotaxin plays an important role in the production of the bioactive lipid lysophosphatific acid (LPA), which in turn controls several cellular activities. Both autotaxin and LPA have been suggested to be involved in asthma, fibrosis, and lung disease.
In the FLORA trial, target engagement will be assessed by measuring LPA levels in the plasma and bronchoalveolar lavage fluid, at baseline and through the 12 weeks of treatment. Secondary endpoints of FLORA include changes in disease biomarkers, the evaluation of lung function, and patients’ quality of life.
“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,” said Dr. Piet Wigerinck, chief scientific officer of Galapagos, in a recent press release.
“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,” Wigerinck said.
Galapagos is planning to complete patient enrollment before the end of 2016, and top-line data from FLORA is expected to be released in the second quarter of 2017.
IPF is a chronic disease that currently has no cure. It is characterized by a progressive decline in lung function. The term pulmonary fibrosis means scarring of lung tissue, and is the cause of worsening dyspnea (shortness of breath). Fibrosis is usually associated with a poor clinical prognosis. IPF belongs to a large group of more than 200 lung diseases known as interstitial lung diseases (ILDs), characterized by the involvement of the lung interstitium.