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.
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 (pirfenidone) and Ofev (nintedanib). 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.
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.
“We are gratified to have feedback on the registrational Phase 3 program from both the FDA and EMA in a broad IPF population. ISABELA is aimed at providing information to support application for a broad label in IPF patients, potentially including monotherapy and add-on. We look forward to starting ISABELA 1 and 2 trials to provide robust answers on efficacy and safety of GLPG1690, an investigational IPF treatment with an innovative mode of action,” said Dr. Walid Abi-Saab, Chief Medical Officer. “Today’s announcement also marks another landmark in our company’s development; we will initiate our first Galapagos-sponsored Phase 3 development program.”
Galapagos will present three abstracts on GLPG1690 at the American Thoracic Society Meeting in San Diego in May 2018.