NEW BRUNSWICK (dpa-AFX) - Johnson & Johnson (JNJ) announced Monday positive topline results from ANTHEM-UC, a Phase 2b study of icotrokinra (JNJ-2113), the first investigational targeted oral peptide that selectively blocks the IL-23 receptor, in adults with moderately to severely active ulcerative colitis (UC).
The study met its primary endpoint of clinical response in all icotrokinra dose groups evaluated and demonstrated clinically meaningful differences versus placebo in key secondary endpoints of clinical remission, symptomatic remission and endoscopic improvement at Week 12.
The topline results show investigational targeted oral peptide icotrokinra achieved clinical remission rates up to 30.2% at Week 12 and a favorable safety profile in Phase 2b ANTHEM-UC study.
The clinical response and remission rates continued to improve through Week 28, building on strong data recently reported for the plaque psoriasis Phase 3 program.
Icotrokinra demonstrates potential to offer therapeutic benefit and tolerability with a once daily oral treatment.
In the ANTHEM-UC study, three doses of once daily icotrokinra were tested with all meeting the primary endpoint of clinical response at Week 12. A response rate of 63.5% for patients treated with the highest dose of icotrokinra was achieved at Week 12 versus 27% for placebo.
Further, 30.2% of patients treated with the highest dose of icotrokinra demonstrated clinical remission at Week 12 versus 11.1% of patients who received placebo. Remission and response rates continued to improve through Week 28.
Icotrokinra was well tolerated with proportions of participants reporting one or more adverse events (AEs) being similar between the icotrokinra dose groups and the placebo group.
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