Thursday, Johnson & Johnson (NYSE:JNJ) released topline data from the pivotal Phase 3 GRAVITI investigational study of Tremfya (guselkumab) subcutaneous (SC) induction therapy in adult patients with moderately to severely active Crohn's disease.

The study met both co-primary endpoints, achieving statistically significant and clinically meaningful outcomes for clinical remission and endoscopic response at Week 12.

All remaining multiplicity-controlled secondary endpoints at Week 12, Week 24 and Week 48 were statistically significant compared to placebo.

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GRAVITI adds to the results demonstrated in GALAXI 2 and GALAXI 3, the first-ever double-blind registrational head-to-head clinical trials to demonstrate superiority versus Stelara (ustekinumab) in key endoscopic endpoints in Crohn's disease, which together show the potential of Tremfya to become the only IL-23 inhibitor to offer both SC or IV induction options.

Safety data from GRAVITI were consistent with the well-characterized safety profile of Tremfya in its approved indications.

A separate Johnson & Johnson study evaluating the efficacy and safety of Tremfya SC induction therapy in ulcerative colitis is ongoing.

Tremfya is approved for the treatment of adults with moderate-to-severe plaque psoriasis who are candidates for injections or pills (systemic therapy) or phototherapy (treatment using ultraviolet light) and for the treatment of adult patients with active psoriatic arthritis.

Price Action: JNJ shares are up 1.12% at $147.29 at last check Thursday.

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