Protagonist Therapeutics announced that data from its Phase 2b ANTHEM-UC study evaluating icotrokinra in ulcerative colitis will be presented at the United European Gastroenterology Week 2025 in Berlin, Germany. The presentation, scheduled for October 7, 2025, will provide 12-week results from the randomized, double-blind, placebo-controlled, dose-ranging trial in patients with moderately to severely active ulcerative colitis.
Trial Design and Presentation Details
Dr. Maria Abreu from Cedars-Sinai Medical Center will present the findings during the "Advanced Therapies in Ulcerative Colitis" session. The presentation, titled "Icotrokinra, a Targeted Oral Peptide that Selectively Blocks Il-23 Receptor Activation, in Moderately to Severely Active Ulcerative Colitis: Week 12 Results from the Phase 2b, Randomized, Double-Blind, Placebo-Controlled, Treat-Through, Dose-Ranging Anthem-UC Trial," is scheduled for 3:06 PM - 3:18 PM CET in the Helsinki Room.
The ANTHEM-UC study represents a significant milestone for icotrokinra, which is described as a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor (IL-23R). The treat-through design and dose-ranging approach of the trial aims to establish optimal dosing parameters for this novel therapeutic approach.
Drug Development Partnership
Icotrokinra, formerly known as JNJ-2113, emerged from a collaboration between Protagonist Therapeutics and J&J Innovative Medicines (formerly Janssen Biotech). Following joint discovery by scientists from both companies under their IL-23R collaboration agreement, Protagonist was primarily responsible for development through Phase 1, with J&J assuming responsibility for Phase 2 and beyond development activities.
The compound is currently licensed to J&J Innovative Medicines, and Protagonist submitted a New Drug Application (NDA) for icotrokinra to the FDA in July 2025, indicating the advanced stage of development for this oral IL-23R antagonist.
Broader Pipeline Context
Beyond icotrokinra, Protagonist Therapeutics maintains a diverse pipeline of peptide-based therapeutics. The company has another advanced candidate, rusfertide, a hepcidin mimetic currently in Phase 3 development for polycythemia vera. Rusfertide is being co-developed and will be co-commercialized with Takeda Pharmaceuticals under a worldwide collaboration agreement established in 2024, with an NDA submission expected by the end of 2025.
The company's preclinical programs include IL-17 oral peptide antagonist PN-881, obesity triple agonist peptide PN-477, and an oral hepcidin program, demonstrating the breadth of Protagonist's proprietary discovery platform in addressing various therapeutic areas.
Clinical Significance
The upcoming presentation of ANTHEM-UC data represents a critical juncture for oral IL-23R antagonist therapy in inflammatory bowel disease. The IL-23 pathway has emerged as an important therapeutic target in ulcerative colitis, and the development of an oral formulation could offer significant advantages over existing injectable biologics targeting this pathway.
The complete data update promised in the presentation will provide the medical community with comprehensive insights into icotrokinra's efficacy and safety profile in the challenging patient population of moderately to severely active ulcerative colitis.
