Galapagos and Gilead commence Phase II trial of filgotinib for uveitis


Belgian biotechnology firm Galapagos and its collaboration partner US-based Gilead Sciences have commenced a Phase II clinical trial of filgotinib to treat patients suffering from uveitis.

Developed using Galapagos’ target and drug discovery technology platform, filgotinib is a highly selective inhibitor of JAK1.

The multi-centre, randomised, double-masked, placebo-controlled Phase II trial is designed to investigate the safety and efficacy of filgotinib in 110 adults with active, non-infectious uveitis over a period of 52 weeks.

Galapagos chief medical officer Dr Walid Abi-Saab said: “We look forward to seeing the study results, which will show whether filgotinib has the potential to impact signs and symptoms of non-infectious uveitis, a group of inflammatory diseases carrying significant visual morbidities.”

"We look forward to seeing the study results, which will show whether filgotinib has the potential to impact signs and symptoms of non-infectious uveitis, a group of inflammatory diseases carrying significant visual morbidities."

The primary objective of the trial is a comparison of the efficacy and safety of filgotinib with placebo for treating non-infectious intermediate-uveitis, posterior-uveitis or pan-uveitis, while the primary outcome is the proportion of patients failing treatment at week 24.

Galapagos and Gilead partnered in December 2015 for the global development and commercialisation of filgotinib to treat inflammatory conditions.

As part of the deal, Gilead will oversee the manufacturing, marketing and sales activities, while Galapagos co-funds 20% of global development activities and holds an option to co-promote the drug in the UK, Germany, France, Italy, Spain, Belgium, the Netherlands and Luxembourg.

The firms are further evaluating filgotinib in additional Phase II trials for cutaneous lupus erythematosus, Sjögren’s syndrome, ankylosing spondylitis and psoriatic arthritis, Phase III clinical programme to treat rheumatoid arthritis, Phase IIb/III trial in ulcerative colitis and in a Phase III trial for Crohn’s disease.