- GLPG1690 has orphan drug status in US and Europe
- Ph II results showed disease stabilization over 12 week period
- ISABELA intended to support NDA and MAA in the US and EU
Galapagos announces the design of a worldwide Phase 3 program, based on feedback from the FDA and EMA, to evaluate GLPG1690 in patients with idiopathic pulmonary fibrosis. 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 USA and EU.
ISABELA 1 and 2 are planned as confirmatory trials and will enroll a total of 1,500 IPF patients combined; patients will continue on their standard of care and will be randomized to one of two doses of the oral investigational drug GLPG1690 or placebo. The primary endpoint will be the rate of decline of FVC (in mL) until week 52. Secondary assessments will include respiratory-related hospitalizations, mortality, quality of life, safety and tolerability.
All patients will continue on their treatment until the last patient in their respective study has completed 52 weeks of treatment. Therefore, some patients will remain in the study for substantially longer than 52 weeks. This approach will allow assessment of less frequent clinical events that are otherwise difficult to assess in conventional clinical studies of one-year duration.
In Ph II trial (FLORA) results, announced in August of 2017, GLPG1690 patients experienced stabilization of the their disease and forced vital capacity (FVC). The placebo group experienced expected disease progression and decrease in FVC
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.