Johnson & Johnson (J&J) has announced promising topline results for icotrokinra, an investigational oral peptide targeting the IL-23 receptor, from the Phase 2b ANTHEM-UC study.
The study focused on adults with moderately to severely active ulcerative colitis and met its primary endpoint of clinical response across all icotrokinra dose groups.
It showed significant differences compared to placebo in key secondary endpoints, including clinical remission, symptomatic remission, and endoscopic improvement at Week 12.
Icotrokinra is the first targeted oral peptide designed to block the IL-23 receptor, which plays a role in inflammatory responses in conditions like ulcerative colitis and plaque psoriasis.
The drug binds to the IL-23 receptor with high affinity, demonstrating potent inhibition of IL-23 signalling in human T cells.
It was jointly discovered and developed under collaboration between Protagonist Therapeutics and Janssen Biotech, a Johnson & Johnson company, initiated in 2017.
Under the agreement, J&J holds exclusive worldwide rights to develop icotrokinra in Phase 2 trials and beyond, with plans to commercialise compounds for various indications.
Icotrokinra is also being studied in the Phase 3 ICONIC programme for moderate-to-severe plaque psoriasis and active psoriatic arthritis.
Johnson & Johnson immunology, gastroenterology disease area lead, vice president Esi Lamousé-Smith said: “These impressive findings show the potential of icotrokinra to transform the treatment paradigm for people living with ulcerative colitis by offering a distinctive combination of therapeutic benefit, tolerability, and convenience with a once-daily oral treatment.
“With over a quarter century of innovation in inflammatory bowel disease, coupled with our deep expertise in the IL-23 pathway, we are excited about these results and the groundbreaking potential of icotrokinra in the treatment of immune-mediated diseases.”
ANTHEM-UC is a multicentre, randomised, placebo-controlled, dose-ranging clinical trial evaluating the efficacy and safety of icotrokinra in 252 patients.
The study tested three doses of icotrokinra were tested, all achieving the primary endpoint of clinical response at Week 12.
The highest dose group showed a 63.5% response rate compared to 27% for placebo.
In addition, 30.2% of patients on the highest dose achieved clinical remission at Week 12 versus 11.1% on placebo.
In the study, Icotrokinra was well tolerated, with adverse event rates similar between icotrokinra and placebo groups.
