NEW BRUNSWICK (dpa-AFX) - Drug major Johnson & Johnson (JNJ) announced Monday positive one-year results from the Phase 3 FUZION study, which showed TREMFYA (guselkumab) maintained or improved fistula remission through 48 weeks in adults with inflammatory bowel disease Crohn's disease or CD.
According to the company, TREMFYA (guselkumab) is the only IL-23 to deliver durable fistula remission through 48 weeks in Crohn's disease with perianal fistula.
Crohn's disease is a chronic inflammatory condition of the gastrointestinal tract with no known cause, but the disease is associated with abnormalities of the immune system that could be triggered by a genetic predisposition, diet, or other environmental factors.
JNJ-developed TREMFYA is the first fully-human, dual-acting monoclonal antibody designed to neutralize inflammation at the cellular source.
In the FUZION randomized, placebo-controlled, double-blind, multicenter, Phase 3 study, the efficacy and safety of TREMFYA is evaluated in adults with Crohn's disease with perianal fistula.
In the Phase 3 study, the company noted that combined fistula remission, which incorporates both clinical and radiologic assessment, was maintained or improved in both TREMFYA maintenance regimens through Week 48. This includes an increase from 28% at Week 24 to 35% at Week 48 in the 100 mg dose group.
Laurent Peyrin-Biroulet, study investigator, stated, 'Perianal fistula remain one of the most debilitating complications of Crohn's disease, where achieving durable disease control beyond symptom improvement is a challenge. The latest findings from the FUZION study, which is the first of its kind in 20 years, shows that patients treated with TREMFYA maintained or improved upon the clinical benefits observed at Week 24, providing encouraging evidence for its use in this patient population.'
The company added that safety findings through Week 48 were consistent with the well-established safety profile of TREMFYA in Crohn's disease.
Johnson & Johnson previously shared Week 24 results from FUZION, which showed that in the overall study population at Week 24, 28% of patients receiving TREMFYA 100 mg q8w and 27% receiving TREMFYA 200 mg q4w achieved combined fistula remission compared with 10% receiving placebo.
Johnson & Johnson maintains exclusive worldwide marketing rights to TREMFYA, manufactured by its unit Janssen Biotech, Inc.
In pre-market activity on the NYSE, JNJ shares were trading at $253.06, down 0.99 percent.
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