Janssen Announces Positive Topline Results from Phase III Trials of Oral IL-23 Antagonist Icotrokinra for Moderate-to-Severe Plaque Psoriasis
Johnson & Johnson
Medical Device R&D and Manufacturer
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On November 18, 2024, Johnson & Johnson announced its IL-23 oral antagonist peptide – Icotrokinra（JNJ-2113）Positive Results from Phase III ICONIC-LEAD and ICONIC-TOTAL Studies. The results show that Icotrokinra achieved the primary endpoint in moderate to severe plaque psoriasis, with industry-leading skin clearance rates and good tolerability.
Icotrokinra is the world's first oral antagonist peptide targeting IL-23, currently under co-development by Johnson & Johnson and Protagonist Therapeutics, Inc. Compared to a range of marketed IL-23 products, the most significant advantage of Icotrokinra is its oral administration. All currently marketed IL-23 products are monoclonal antibody injections that require injection. After this Phase III study met its primary endpoint, Protagonist will receive a milestone payment of $165 million.
Johnson & Johnson disclosed the results of two Phase III studies on this drug. Among them, the ICONIC-LEAD study is a Phase III multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate Icotrokinra in treating patients with moderate to severe plaque psoriasis undergoing randomized withdrawal and re-treatment.(Adults + Adolescents over 12 years old)The efficacy and safety. The treatment lasted for 156 weeks, with patients randomly assigned 1:1 to the experimental group/placebo group. In the experimental group, subjects took Icotrokinra orally once daily from weeks 0 to 24. At week 24, adult patients meeting specific criteria were re-randomized to receive either Icotrokinra or placebo, while those not meeting the criteria and all adolescent subjects continued on Icotrokinra. From week 52 onward, all subjects in the experimental group resumed Icotrokinra treatment. In the placebo group, subjects took placebo orally once daily from weeks 0 to 16, then crossed over to receive Icotrokinra and placebo starting from week 16.
The study has two primary endpoints: 1) the proportion of participants achieving IGA 0/1 with a score change >=2 at Week 16; 2) the proportion of participants achieving PASI 90 at Week 16.
The study met two primary endpoints. More data showed that by week 16, nearly two-thirds（64.7%）Subjects treated with Icotrokinra achieved IGA 0/1, with 49.6% of patients reaching PASI 90, compared to 8.3% and 4.4% in the placebo group, respectively. By week 24, symptoms continued to improve, with 74.1% of subjects treated with Icotrokinra achieving IGA 0/1 and 64.9% reaching PASI 90.
The ICONIC-TOTAL study focuses on evaluating the efficacy and safety of Icotrokinra in treating patients with moderate to severe plaque psoriasis involving special areas. The treatment lasts for 156 weeks, with participants randomly assigned to the experimental group or the placebo group, receiving once-daily oral Icotrokinra or placebo. In the experimental group, participants take Icotrokinra once daily from week 0 to week 156. In the placebo group, participants take placebo once daily from week 0 to week 16 and then switch to once-daily oral Icotrokinra starting from week 16.
The primary endpoint of the study was: the proportion of subjects with an IGA score of 0/1 and a change in score >=2 at week 16.
The study met its primary endpoint, but detailed data has not been disclosed yet.
Johnson & Johnson is an old player in the IL-23 field. Its earlier blockbuster product, ustekinumab, which targets IL-12/IL-23, generated billions in sales, while another $3 billion product, guselkumab, targets IL-23 (p19 subunit). Currently, ustekinumab is facing a patent cliff, leading to declining sales; the sales growth of guselkumab has also slowed down. Johnson & Johnson indeed needs a strong enough product to bolster its entire autoimmune segment.
References:
1.Official Websites of Various Companies
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