Galapagos announces ISABELA Phase 3 program in IPF - Seite 2

Galapagos will present three abstracts on GLPG1690 at the American Thoracic Society Meeting in San Diego in May 2018.

About GLPG1690
GLPG1690 is a small molecule, selective autotaxin inhibitor which is fully proprietary to Galapagos. Galapagos identified the autotaxin target using its proprietary target discovery platform and developed molecule GLPG1690 as an inhibitor of this target. Oral investigational drug GLPG1690 showed 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. GLPG1690 appeared to halt disease progression as measured by FVC at 12 weeks and was well-tolerated by IPF patients in the FLORA Phase 2a trial reported in August 2017. Galapagos received orphan drug designation for GLPG1690 in IPF from the U.S. Food & Drug Administration (FDA) and European Commission (EC). GLPG1690 is an investigational drug and its efficacy and safety have not been established.

Preliminary information for patients and healthcare professionals to be found at www.isabelastudies.com. For more information about GLPG1690: www.glpg.com/glpg-1690.

About IPF
IPF is a chronic, relentlessly progressive fibrotic disorder of the lungs that typically affects adults over the age of 40. IPF affects approximately 200,000 patients in the United States and Europe and, as such, we have received orphan designation for our product candidate GLPG1690 in IPF from the European Commission and from the FDA. The clinical prognosis of patients with IPF is poor, as survival at diagnosis is two to four years. Currently, no medical therapies have been found to cure IPF. The medical treatment strategy aims to slow disease progression and improve 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 mild to moderate IPF. Both Esbriet and Ofev have been shown to slow the rate of functional decline in IPF and are gaining ground as the standard of care worldwide. Combined sales of both drugs reached $1.1 billion in 2016, with 74% of global revenues being in the United States. These regulatory approvals represent a major breakthrough for IPF patients; yet neither drug improves lung function, and the disease in most patients on these therapies continues to progress. Moreover, the adverse effects associated with these therapies are considerable (e.g., diarrhea, liver function test abnormalities with Ofev, nausea and rash with Esbriet). Therefore, there is still a large unmet medical need as IPF remains a major cause of morbidity and mortality. We estimate global sales of approved IPF drugs will grow to nearly $5 billion in 2025.