Galapagos NV announces ISABELA Phase 3 program in IPF
Galapagos NV 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 and Market Authorization Application submissions in respectively the USA and EU.The global Phase 3 program is expected to consist of two identically designed trials, ISABELA 1 and ISABELA 2. These will enroll patients diagnosed with IPF on top of their local standard of care, whether or not they were previously or currently are treated with Esbriet(and Ofev. Recruitment will be worldwide, with a significant proportion of patients in the USA and Europe. This Phase 3 program is expected to start dosing in the second half of 2018.