Johnson & Johnson Announces Positive Phase 2b Results for Oral IL-23R-Targeted Peptide Icotrokinra in Ulcerative Colitis

Mar 12, 2025 09:24 CST Updated 09:24

Johnson & Johnson

Medical Device R&D and Manufacturer

｜Edited by the Peptide Biotech Content Team

March 202510DayJohnson & Johnson announced positive topline results from the ANTHEM-UC study, a Phase 2b trial of icotrokinra (JNJ-2113) in adult patients with moderate to severe active ulcerative colitis (UC). Icotrokinra is the first targeted oral peptide that selectively blocks the IL-23 receptor. The study met the primary endpoint of clinical response across all evaluated dose groups of icotrokinra and demonstrated clinically meaningful differences compared to placebo at Week 12 for key secondary endpoints (clinical remission, symptomatic remission, and endoscopic improvement).

In the ANTHEM-UC study (n=252), three once-daily doses of icotrokinra were tested, and all doses met the primary endpoint of clinical response at week 12. At week 12, the response rate was 63.5% for patients receiving the highest dose of icotrokinra, compared to 27% in the placebo group (p<0.001). In a cross-comparison with other drugs targeting the same pathway, the response rate of icotrokinra (adjusted for the placebo group) was higher than that of other monoclonal antibodies and comparable to the JAK inhibitor Rinvoq (upadacitinib).

Icotrokinra was co-discovered and developed by Protagonist and Johnson & Johnson under a licensing and collaboration agreement. Johnson & Johnson retains exclusive global rights to develop icotrokinra through Phase 2 clinical trials and beyond, as well as to commercialize compounds arising from the research conducted under the agreement for a broad range of indications.

AboutJNJ-2113

JNJ-2113 is a first-in-class oral peptide IL-23R antagonist that binds to the IL-23 receptor with high affinity. It can be absorbed through oral administration, selectively blocking IL-23 signaling and the production of downstream inflammatory cytokines. The IL-23/IL-23R signaling pathway plays a crucial role in the pathogenesis of immune-mediated inflammatory diseases, including psoriasis, psoriatic arthritis, and inflammatory bowel disease.

AboutJohnson & Johnson

Johnson & Johnson, founded in 1886, is one of the most comprehensive healthcare product enterprises with a wide range of business operations globally, covering medical technology and innovative pharmaceuticals. Headquartered in New Brunswick, New Jersey, USA, Johnson & Johnson successfully completed the spin-off of its consumer health business in 2023 and announced a brand renewal. The company integrated its two major businesses, medical technology and innovative pharmaceuticals, under the Johnson & Johnson name, marking a new chapter in the company's century-long history.

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