JanssenJohnson & 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.

Janssen's Tremfya

Tremfya (guselkumab) won FDA approval for adult patients with active psoriatic arthritis in 2020.

The placebo-controlled double-blind study’s primary endpoint was the change from baseline CDAI scores at week 12.

“We look forward to sharing the comprehensive GALAXI 1 48-week results at an upcoming scientific medical meeting while we continue to progress and enroll patients in the pivotal Phase 3 GALAXI 2 and 3 studies,” said Dr. Jan Wehkamp, vice president, gastroenterology disease area leader at Janssen Research & Development, in a statement.

The GALAXI 1 study focused on CD who had an inadequate response/intolerance to conventional therapies such as corticosteroids or immunosuppressives or biologics such as TNF antagonists or vedolizumab.

“Overall, the unmet medical need for patients around the world with immune- and autoimmune-mediated inflammatory diseases is still very high,” said Wehkamp in an October interview with Drug Discovery & Development. “So, we aren’t stopping.”

Janssen is continuing to enroll individuals in the Phase 3 GALAXI 2 and 3 studies.