High Dose of Gilead and Galapagos’ JAK-Inhibitor Filgotinib Hits the Mark in UC Study

Hit the mark

A high dose of filgotinib, the JAK1 inhibitor under long-term development by Gilead Sciences and Galapagos NV, proved effective in a Phase IIb/III study as a treatment for patients with moderately to severely active ulcerative colitis, the companies announced this morning.

The companies said a 200 mg dose of filgotinib hit the mark by achieving all primary endpoints in the study, inducing clinical remission at Week 10 and maintaining clinical remission at Week 58 in a significantly higher proportion of patients compared with placebo. But, the news was something of a mixed bag, as the companies said the low-dose treatment being assessed in the same study failed to achieve its primary endpoint of statistically significant clinical remission at Week 10.

The two companies, which last year struck a 10-year development collaboration valued at more than $5 billion, have been looking to filgotinib as a potential rival to other JAK inhibitors that currently hold a strong share of the market in several indications, including Pfizer’s Xeljanz, Eli Lilly’s Olumiant and AbbVie’s Rinvoq. Filgotinib is currently under review by the U.S. Food and Drug Administration as a potential treatment for rheumatoid arthritis. The JAK1 inhibitor is also being assessed as a potential treatment for Crohn’s disease, psoriatic arthritis, uveitis and in small bowel and fistulizing Crohn’s disease. Last year the drug failed in a late-stage lupus study.

The Phase IIb/III study looked a biologic-naïve or biologic-experienced adult patients with moderately to severely active ulcerative colitis (UC), a chronic inflammatory disease affecting the colon that often includes periods of remission and periods of active disease. With the 200mg dose, 26.1% of biologic-naïve patients achieved clinical remission at 10 weeks compared to 15.3% of placebo patients. Among biologic-experienced patients, a statistically significant higher proportion of patients achieved clinical remission at Week 10 when treated with filgotinib 200 mg, 11.5% compared to 4.2%, the companies said.

Gilead Sciences and Belgium-based Galapagos said both dose levels of filgotinib achieved the primary endpoint in this maintenance trial. At Week 58, 37.2% of biologic-naïve and biologic-experienced patients receiving filgotinib 200 mg achieved clinical remission, compared with 11.2% treated with placebo. Of patients receiving filgotinib 100 mg, 23.8% achieved clinical remission at Week 58, compared with 13.5% on placebo. Detailed results from the SELECTION trial will be submitted for presentation at a future scientific conference.

Merdad Parsey, chief medical officer for Gilead Sciences, called the Phase IIb/III results of filgotinib as an induction therapy and maintenance therapy encouraging.

 “Patients with moderate to severe ulcerative colitis can struggle to effectively manage their disease. These topline data suggest that filgotinib could play a role in helping more patients achieve a meaningful and sustained improvement in treatment response with an oral therapy,” Parsey said in a statement.

Galapagos CMO Walid Abi-Saab noted that the results from the SELECTION trial indicate filgotinib can help ulcerative colitis patients, including those refractory to treatment, as well as achieve and sustain remission for more than one year.

“We believe that the results point to an efficacy and safety profile consistent with prior studies with filgotinib, and offer a meaningful contribution to the patient data with filgotinib from other inflammatory conditions,” Abi-Saab said.

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