Johnson & Johnson (J&J) has announced positive phase 3 results for Tremfya (guselkumab) in adult patients with moderately to severe active Crohn’s disease (CD).
The company’s GALAXI programme, comprising of three studies, GALAXI 1, 2 and 3, has been evaluating the safety and efficacy of Tremfya in comparison to Stelara (ustekinumab).
Affecting an estimated three million people in the US and four million people across Europe, CD is one of the two main forms of inflammatory bowel disease (IBD), a chronic, inflammatory gastrointestinal (GI) condition that results in prolonged inflammation and damage to the GI tract.
Already approved to treat active psoriatic arthritis and moderate-to-severe plaque psoriasis, Tremfya works by blocking IL-23 and inhibiting the release of cytokines and chemokines that cause inflammation.
The two confirmatory studies, GALAXI 2 and 3, evaluated maintenance doses of 100mg every eight weeks and 200mg every four weeks in patients with CD and met the composite co-primary endpoints compared to placebo.
When compared to Stelara, both doses demonstrated significant and clinically meaningful superiority in all pooled endoscopic endpoints, including endoscopic response, endoscopic remission, clinical remission and endoscopic response and deep remission, at 48 weeks.
In addition, the safety profile observed in the GALAXI programme was consistent with previous trials in already-approved indications and earlier IBD.
David Lee, global therapeutic area head, immunology, J&J Innovative Medicine, commented: “These findings demonstrate the promise of Tremfya for patients living with moderately to severely active CD compared to conventional and advanced therapies.”
“These results… offer the possibility of Tremfya as a future-first advanced therapy or after failure of other advanced therapies that may deliver the lasting remission patients deserve to relieve the burden of disease,” said lead study investigator Remo Panaccione, professor of medicine, University of Calgary.
The results follow J&J’s recent submission of applications to the European Medicines Agency to expand the marketing authorisation application for Tremfya to include adult patients with moderately to severely active ulcerative colitis and moderately to severely active CD, along with regulatory applications seeking approval of Tremfya to treat adults with moderately to severely active UC in countries or regions including the US.