Galapagos NV recently announced the launch of an exploratory Phase 2a clinical trial, called FLORA, evaluating the company’s proprietary drug GLPG1690 in patients with idiopathic pulmonary fibrosis (IPF).
Esbriet (pirfenidone) and Ofev (nintedanib) are the only approved therapies for the treatment of IPF, and both have been shown to slow the progression of lung decline. Despite being the standard of IPF care worldwide, however, neither drug improves lung function, and the disease progresses in the majority of the cases. Adverse effects often associated with these two therapies include diarrhea, liver function abnormalities with nintedanib, and nausea and rash with pirfenidone.
The primary objectives of the FLORA study will be to assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of a once-daily oral dose of GLPG1690 in 24 IPF patients in a randomized, double-blind, placebo-controlled setting. The study, to be conducted for a period of 12 weeks, is recruiting patients in Europe.
GLPG1690 is a small molecule inhibitor of autotaxin, a molecule that plays an important role in the production of the bioactive lipid lysophosphatific acid (LPA), which controls several cellular activities. Both autotaxin and LPA are thought to be involved in conditions like fibrosis, asthma, and lung disease.
LPA levels in the plasma and bronchoalveolar lavage fluid will be used to measure target engagement of GLPG1690, both at baseline and across the 12 weeks of treatment. The study’s secondary objectives include assessment of lung function, changes in disease biomarkers, 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,” Piet Wigerinck, Galapagos’ chief scientific officer, said in a 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.”
Galapagos plans to conclude patient recruitment before the beginning of 2017, and to report topline results in the second quarter of that year.
More information on the FLORA trial, including how to participate at sites in Italy, the U.K. and Ukraine, is available through this link.
IPF is a chronic, progressive fibrotic disease that affects the lungs, typically in adults over age 40. According to a Global Data EpiCast Report, published in April 2013, IPF affects just under 30 in every 100,000 people in Europe and the U.S., and is considered a rare disease.
Prognosis is often poor, with median survival at diagnosis between two and five years. There are no current therapies to cure IPF, and despite medical treatments being able to slow disease progression and improve quality of life, lung transplantation may be an option for eligible patients.