Galapagos has tested its filgotinib – JAK1 inhibitor – in a phase 2 study, for the patients with Chron’s disease, and it has published the results in The Lancet. Filgotinib is an investigational drug and its efficacy and safety have not been established.
Filgotinib could represent the first new oral treatment for CD in many years. Phase 3 study has now been kicked off with the compound, said Dr Séverine Vermeire, who describes the study in the publication.
Fitzroy was the first double-blind, placebo-controlled study to use centrally read endoscopies to ensure the selective recruitment of patients with active disease including mucosal ulceration, said Dr Vermiere.
The Lancet also published an editorial that highlights the Fitzroy study and results: “There are several strengths in this well-designed trial. The use of a number of clinical, endoscopic, and biochemical endpoints ensures robustness of benefit of treatment and provides strong support for further investigation of this therapeutic mechanism. The requirement of endoscopically active disease at randomization and use of central readers to adjudicate eligibility and efficacy increased the clarity in the efficacy signal and reduced the potential of bias,” said Dr Ashwin Ananthakrishnan in a comment in the same issue of The Lancet.
Galapagos and Gilead are working together on developing filgotinib in inflammatory indications. The team will also market it together once approved.
As a part of the teamwork, Gilead is working on a Phase 3 study of filgotinib in rheumatoid arthritis in August, another Phase 3 study in CD in November and the a Phase 2b/3 program in ulcerative colitis in December.