By Anna Bratulic
Johnson & Johnson’s icotrokinra met the primary endpoint of a Phase IIb ulcerative colitis (UC) study, building on its recent success in psoriasis. The IL-23-blocking oral peptide could also boost the company’s efforts to stay ahead in immunology as Stelara (ustekinumab) stares down biosimilar competition.
In the ANTHEM-UC study, J&J tested three once-daily doses of icotrokinra and found that the highest one led to a clinical response in 63.5 per cent of patients after 12 weeks, compared to just 27 per cent for placebo. The drug also showed “meaningful differences” on secondary measures like clinical remission, with 30.2 per cent of patients on the highest dose achieving remission versus 11.1 per cent for placebo. J&J said the benefits kept improving through week 28, with a favourable safety profile.
The trial enrolled 252 patients with moderately to severely active UC who’d had an inadequate response or intolerance to conventional therapy. More ANTHEM-UC results will be shared at upcoming medical congresses.
“These impressive findings show the potential of icotrokinra to transform the treatment paradigm… by offering a distinctive combination of therapeutic benefit, tolerability, and convenience with a once-daily oral treatment,” said gastroenterology disease area lead at J&J, Esi Lamousé-Smith in a release recently.
The icotrokinra results complement J&J’s recent efforts to strengthen its IL-23 lineup, including September’s FDA approval of Tremfya (guselkumab) for UC with intravenous induction and subcutaneous maintenance, and a pending application for a fully subcutaneous regimen. According to data presented last month, Tremfya’s SC induction demonstrated significantly higher rates of clinical remission (27.6% vs 6.5%) and response (65.6% vs 34.5%) versus placebo at week 12 in the Phase III ASTRO trial.
Both icotrokinra and Tremfya are being positioned to help offset expected revenue declines from Stelara, which saw a 4.6 per cent global sales drop in 2024 as biosimilars enter the market.
The UC data for icotrokinra follows its strong showing in psoriasis at the American Academy of Dermatology (AAD) meeting over the weekend. The ICONIC-ADVANCE 1 and 2 trials not only met their primary endpoints of achieving clear or nearly clear skin, but also demonstrated superiority to Bristol Myers Squibb’s oral TYK2 inhibitor Sotyktu (deucravacitinib).
