Johnson & Johnson’s Janssen division (NYSE:JNJ) has released topline results from the Phase 2 GALAXI 1 clinical study testing the potential of TREMFYA (guselkumab) in patients with moderately to severely active Crohn’s disease (CD).
The study found that nearly two-thirds (65%) of TREMFYA (guselkumab) recipients achieved clinical remission at week 48. The trial used the Crohn’s Disease Activity Index [CDAI]<150) to verify that benchmark.
The study provided the first long-term data testing guselkumab as a potential CD treatment in the U.S.
Guslkumab selectively inhibits the p19 subunit of interleukin IL-23.
Guselkumab is now FDA approved for moderate-to-severe plaque psoriasis and active psoriatic arthritis, but not yet for Crohn’s disease.
Tremfya (guselkumab) won FDA approval for adult patients with active psoriatic arthritis in 2020.
The placebo-controlled double-blind stu…