Phase 3 IPF Program Design Revealed by Galapagos

This morning, Galapagos announced the design of its global Phase 3 program of GLPG1690 in patients with idiopathic pulmonary fibrosis (IPF).

The worldwide program is based on feedback from both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA), and is expected to consist of a pair of identically designed trials — ISABELA 1 and ISABELA 2 – both of which will enroll patients diagnosed with IPF on top of their local standard of care.

Approximately 1,500 patients will be recruited for the trials, primarily in the US and Europe, whether or not they were previously or are currently being treated with pirfenidone (Esbriet) or nintedanib (Ofev). Dosing is expected to be initiated in the second half of 2018.

"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 in a press release.

GLPG1690 is a small molecule, selective autotaxin inhibitor, developed after Galapagos identified the autotaxin target using its proprietary target discovery platform. ISABELA 1 and 2 are planned as confirmatory trials; patients will continue their standard of care and will be randomized to 1 of 2 doses of either the oral investigational drug GLPG1690 or placebo. The rate of decline of forced vital capacity (FVC) (in mL) until week 52 will serve as the trial’s primary endpoint, and secondary assessments will include respiratory-related hospitalizations, mortality, quality of life, safety and tolerability.

At present, pirfenidone and nintedanib are the only approved therapies intended specifically to treat mild to moderate IPF. Both have demonstrated the ability to slow the rate of functional decline in IPF, however, neither drug improves lung function, and the disease in most patients administered these therapies continues to progress. Moreover, the adverse effects (AEs) associated with these therapies are considerable.

In the video below, Albert Rizzo, M.D. of the Christiana Care Pulmonary and Critical Care Medicine Section discusses previous, current and emerging therapies for idiopathic pulmonary fibrosis.

For more on IPF and other rare diseases, follow Rare Disease Report on Facebook and Twitter.