Johnson & Johnson (J&J) has shared positive topline results from a late-stage study evaluating a subcutaneous (SC) version of its IL-23 inhibitor Tremfya (guselkumab) in Crohn’s disease (CD).
The phase 3 GRAVITI trial has been investigating the use of Tremfya SC induction therapy in adults with moderately to severely active CD.
CD is one of the two main forms of inflammatory bowel disease, which affects approximately four million people in Europe.
Symptoms of CD vary, but often include abdominal pain and tenderness, frequent diarrhoea, rectal bleeding, weight loss and fever.
Tremfya is designed to block IL-23, an important driver of the pathogenesis of inflammatory diseases, and already holds approvals to treat specific cases of plaque psoriasis and psoriatic arthritis.
GRAVITI met both its co-primary endpoints, achieving statistically significant and clinically meaningful outcomes for clinical remission as well as endoscopic response at week 12.
All remaining multiplicity-controlled endpoints at weeks 12, 24 and 48 were also statistically significant compared to placebo, J&J said, adding that the safety data was consistent with the “well-characterised” safety profile of the therapy in its approved indications.
The results from GRAVITI build on those seen in the GALAXI 2 and GALAXI 3 trials, in which Tremfya demonstrated superiority of two SC maintenance doses versus placebo and Stelara (ustekinumab) in CD patients.
The company outlined that, together, the results from the three studies “show the potential of Tremfya to become the only IL-23 inhibitor to offer both SC or intravenous (IV) induction options”.
David Lee, global therapeutic area head, immunology, J&J Innovative Medicine, said: “The phase 3 GRAVITI study showed promising results with SC induction and provides similar clinical benefit to what was seen with IV induction in the GALAXI studies.
“Having both SC and IV induction options provides choice and versatility for patients and providers. Tremfya is poised to be the only IL-23 inhibitor to offer a full SC therapy for both induction and maintenance in CD,” Lee said.
The latest results for Tremfya come just days after J&J shared positive mid-stage data for its investigational anti-FcRn antibody nipocalimab in the chronic autoimmune condition Sjögren’s disease.