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Filgotinib achieved all primary end points of the phase 2b/3 study in patients with moderate-to-severe ulcerative colitis.
Gilead Sciences, Inc. and Galapagos NV announced favorable topline results from a phase 2b/3 clinical trial, which assessed the safety and efficacy of investigational filgotinib in treating adult patients with moderately to severely active ulcerative colitis (UC).
Filgotinib is an oral, once-daily, selective Janus kinase 1 (JAK1) inhibitor not yet approved by the FDA for any use, though regulatory submissions of the drug for the treatment of rheumatoid arthritis are currently under review.
UC is a chronic, idiopathic inflammatory disease that negatively affects the colon, often involving both periods of remission and active disease. UC is frequently diagnosed in individuals who are of working age and may face debilitating flares in their symptoms as well as disease progression over time. Approximately 40% of patients experience an annual relapse and fail to achieve sustained remission.
“We are pleased to see that SELECTION results indicate that filgotinib can help ulcerative colitis patients, including those refractory to treatment, achieve and sustain remission for more than 1 year,” said Dr Walid Abi-Saab, chief medical officer, Galapagos. “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. We look forward to presenting more detailed results to the scientific community.”
The multi-center, randomized, double-blind, placebo-controlled, phase 2b/3 SELECTION trial evaluated the UC treatment in 1348 biologic-naÃ¯ve or biologic-experienced adult patients with moderately to severely active UC. Individuals who received 200 mg of filgotinib achieved all primary end points designated by the study, including clinical remission at week 10, and maintained clinical remission at week 58 at a significantly higher rate than placebo. Among biologic-naÃ¯ve patients, 26.1% of patients receiving filgotinib achieved clinical remission at week 10, compared with 15.3% of those receiving placebo. Among biologic-experienced patients, 11.5% of those treated with filgotinib achieved clinical remission compared with 4.2% of those treated with placebo.
At week 58, 37.2% of biologic-naÃ¯ve and biologic-experienced patients receiving filgotinib achieved clinical remission, whereas 11.2% receiving placebo achieved the same, according to the results.
The study reported low rates of severe infections, herpes zoster, venous thrombosis, pulmonary embolism, and gastrointestinal perforation in both groups during the induction and maintenance phases of the SELECTION trial. A total of 4.5% of participants receiving filgotinib experienced a serious adverse event.
“We are encouraged by the early response as an induction therapy and the durable efficacy as a maintenance therapy observed in the SELECTION trial,” said Merdad Parsey, MD, PhD, chief medical officer, Gilead Sciences. “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.”
Investigators asserted that the SELECTION trial results will be submitted for presentation at a future scientific conference.
1. Gilead and Galapagos Announce Positive Topline Results of Phase 2b/3 Trial of Filgotinib in Moderately to Severely Active Ulcerative Colitis. News Release. Gilead; May 20, 2020. Accessed May 26, 2020. https://www.gilead.com/news-and-press/press-room/press-releases/2020/5/gilead-and-galapagos-announce-positive-topline-results-of-phase-2b3-trial-of-filgotinib-in-moderately-to-severely-active-ulcerative-colitis