After a phase 3 trial flop, Galapagos’ JAK1 preferential inhibitor filgotinib won't be launching in Crohn’s disease anytime soon.
The drug, branded as Jyseleca in Europe, has had a rough go of it over the last few years. After losing most of its Gilead Sciences partnership and failing to net a U.S. approval thanks to testicular toxicity concerns, the drug's future rests on launches outside the States.
Now, Jyseleca has flopped a pivotal study in Crohn's disease, Galapagos reports.
The trial, which tested the medicine as an induction and maintenance therapy in both biologic-naïve and biologic-experienced patients with moderate to severe Crohn’s disease, found that both patient cohorts on the induction side failed to achieve clinical remission and an endoscopic response. The trial, therefore, missed this co-primary endpoint.
The drug fared better in the maintenance phase of the study, with 43.8% of patients on 200 mg Jyseleca achieving clinical remission compared with the placebo group’s 26.4%. Also in the maintenance phase, 30.4% of patients achieved an endoscopic response, compared with 9.4% on placebo, at week 58. Jyseleca hit its co-primary endpoint in the maintenance phase of the study.
Galapagos is “very disappointed with this outcome,” Daniele D’Ambrosio, M.D., therapeutic area head of immunology, said in a statement. Still, the company remains “fully committed” to the drug in its approved indications and remains on track to kickoff a phase 3 study in axial spondylarthritis, a type of arthritis, this year.
Galapagos' drug already carries approvals in Europe, Great Britain and Japan to treat certain patients with rheumatoid arthritis and ulcerative colitis. While a launch in Crohn’s has long been a goal for Galapagos and prior partners, the latest trial results show a swing and a miss.
While the data won't enable a Crohn's application in Europe, the company will analyze the full results to gain “valuable insights to guide future research efforts,” D’Ambrosio added.
This is only the latest blow to the drug. Late last year, the European Medicines Agency’s safety committee recommended limited use of a group of oral JAK inhibitors, including Jyseleca, in certain at-risk patients.
Even before that, the FDA rejected the drug in August 2020, and Gilead scaled back a Galapagos partnership later in the year.
AbbVie previously had a collaboration with Galapagos on filgotinib, but it walked away in 2015 to focus on Rinvoq.