J&J and Protagonist Therapeutics are collectively developing icotrokinra, which is poised to be an immunology blockbuster. Image credit: Emily frost / Shutterstock.
Johnson & Johnson (J&J) and Protagonist Therapeutics’s joint interleukin-23 (IL-23) inhibitor, icotrokinra, has met the primary endpoint in a Phase IIb study in patients with moderately to severely active ulcerative colitis (UC).
J&J conducted the ANTHEM-UC trial (NCT06049017) of icotrokinra, an investigational targeted oral peptide that selectively blocks the IL-23 receptor, which reported a clinical response rate of 63.5% in patients treated with the highest dose of icotrokinra after 12 weeks compared to 27% in the placebo arm, measured on the Mayo Score / Disease Activity Index (DAI).
The study also met a key secondary endpoint, with 30.2% of patients in the high-dose group achieving clinical remission compared to 11.1% of placebo patients. Remission and response continued to improve through week 28.
Other endpoints included symptomatic remission and endoscopic improvement.
The ANTHEM-UC study evaluated three doses of once-daily icotrokinra, with the drug being well tolerated by the proportion of patients reporting one or more adverse events (AEs) being similar between the icotrokinra and placebo groups. Full data from the study will be presented at upcoming medical congresses.
Dr Esi Lamousé-Smith, vice president, gastroenterology disease area lead, Immunology, J&J, said: “These impressive findings show the potential of icotrokinra to transform the treatment paradigm for people living with UC 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.”
The therapy is being developed as part of a licence and collaboration agreement, which was established between Janssen Biotech, now J&J Innovative Medicine, and Protagonist Therapeutics in 2017. Protagonist’s stock, listed on the Nasdaq market, rose 45.89% on the news. J&J’s stock, listed on the New York Stock Exchange (NYSE), saw a minor 1.38% rise after the data was announced.
GlobalData predicts that icotrokinra will reach blockbuster status in 2029, with the drug forecast to generate sales of $2.19bn in 2030.
GlobalData is the parent company of Clinical Trials Arena.
The IL-23 market is heavily populated with several blockbuster drugs, including AbbVie’s Skyrizi (risankizumab-rzaa). J&J is already a big name in the space with blockbuster therapies Stelara (ustekinumab), an IL-12 and IL-23 inhibitor, and Tremfya (guselkumab), an IL-23 inhibitor.
Stelara sales are now dropping as the biosimilar market opens up. Meanwhile, Tremfya could be poised to take its place as the company’s flagship immunology product. The therapy received approval from the US Food and Drug Administration (FDA) for use in UC on 11 September 2024. It first gained approval in the US in July 2017 for plaque psoriasis and received approval for psoriatic arthritis in July 2020. J&J is hoping for approval for Tremfya in Crohn’s disease after a positive Phase III programme.
Tremfya is a subcutaneous therapy administrated at week 0, week 4 and every 8 weeks after. Meanwhile, icotrokinra is an oral tablet that is dosed once daily.
J&J recently released data from a Phase III programme of icotrokinra in plaque psoriasis, meeting the co-primary endpoints in both studies. The pill is set to be put up against Stelara in another Phase III trial. In November 2024, the Phase III ICONIC-LEAD trial of icotrokinra in plaque psoriasis also met its primary endpoint.
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