Galapagos Initiates Phase IIa Study


Galapagos NV recently announced the start of its exploratory Phase IIa study with GLPG1690 in idiopathic pulmonary fibrosis (IPF) patients, named FLORA, 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 12 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 preclinical 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.

IPF is a chronic, relentlessly progressive fibrotic disorder of the lungs that typically affects adults over the age of 40. According to an April 2013 GlobalData EpiCast report, the prevalence of IPF is <30 per 100,000 persons in both Europe and the US, and as such, IPF is considered a rare disease. The clinical prognosis of patients with IPF is poor as the median survival at diagnosis is 2 to 5 years. Currently, no medical therapies have been found to cure IPF. The medical treatment strategy aims to slow the disease progression and improve the quality of life. Lung transplantation may be an option for appropriate patients with progressive disease and minimal comorbidities.

Regulatory agencies have approved Esbriet (pirfenidone) and Ofev (nintedanib) for the treatment of IPF. Both pirfenidone and nintedanib have been shown to slow the rate of lung function decline in IPF and are likely to become the standard of care worldwide. These regulatory approvals represent a major breakthrough for IPF patients; yet neither drug improves lung function, and the disease continues to progress in the majority of patients despite treatment. Moreover, the adverse effects associated with these therapies include diarrhea, liver function test abnormalities with nintedanib, nausea, and rash with pirfenidone. Therefore, there is still a large unmet medical need as IPF remains a major cause of morbidity and mortality.

Galapagos is a clinical-stage biotechnology company specialized in the discovery and development of small molecule medicines with novel modes of action. Our maturing pipeline comprises Phase II, Phase I, preclinical candidates and discovery studies in cystic fibrosis, inflammation, fibrosis, osteoarthritis, and other indications. We have discovered and developed filgotinib: in collaboration with Gilead we aim to bring this JAK1-selective inhibitor for inflammatory indications to patients all over the world. Galapagos is focused on the development and commercialization of novel medicines that will improve people’s lives. The Galapagos group, including fee-for-service subsidiary Fidelta, has approximately 440 employees, operating from its Mechelen, Belgium headquarters and facilities in The Netherlands, France, and Croatia. For more information, visit www.glpg.com.