▎WuXiEdited by Kant Content Team

Recently, Johnson & Johnson announced positive topline results from its pivotal Phase 3 study, ICONIC-LEAD. The potential "first-in-class" IL-23 receptor (IL-23R) targeted antagonistic peptide icotrokinra (JNJ-2113) met the dual primary endpoints of the trial, significantly improving symptoms in adult and adolescent patients aged 12 years and older with moderate to severe plaque psoriasis (PsO).According to the press release, icotrokinra is the first targeted oral peptide in development aimed at blocking IL-23R.

Analysis shows that once-daily icotrokinra significantly improved skin conditions in patients with moderate to severe plaque psoriasis.At week 16, 64.7% of patients in the icotrokinra group achieved an Investigator Global Assessment (IGA) score of 0/1 (clear or almost clear skin), and 49.6% of patients achieved at least a 90% improvement in the Psoriasis Area and Severity Index (PASI 90)., while the values for these two indicators in the placebo group were only 8.3% and 4.4%, respectively.To theAt 24 weeks, the patient remission rate further increased, with 74.1% of patients achieving an IGA score of 0/1 and 64.9% of patients achieving PASI 90.

In terms of safety, the data showed consistency with the previous Phase 2 studies (FRONTIER 1 and 2).At week 16, the incidence of adverse events (AE) in the icotrokinra group and placebo group was similar, at 49.3% and 49.1%, respectively, with no significant difference in the proportion of treatment-emergent adverse events (TEAE).

Moreover, the topline results of another Phase 3 study, ICONIC-TOTAL, also demonstrated that the trial met its primary endpoint. At week 16, once-daily icotrokinra showed significantly superior efficacy compared to placebo, with a notably higher proportion of patients achieving an IGA score of 0/1. The full results of ICONIC-LEAD and ICONIC-TOTAL are currently being compiled and are planned for presentation at upcoming medical conferences, with subsequent submission to relevant regulatory authorities.

IL-23 plays a key role in the pathogenic T-cell activation in moderate to severe plaque PsO and is fundamental to inflammatory responses in PsO and other dermatologic, rheumatologic, and IL-23-mediated gastrointestinal diseases.Icotrokinra can bind to IL-23R with single-digit picomolar affinity and exerts potent selective inhibition of IL-23 signaling in human T cells.In 2017, Janssen Biotech and Protagonist Therapeutics reached a nearly $1 billion collaboration agreement to jointly develop oral therapies targeting IL-23R.

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References:

[1] Icotrokinra delivered an industry-leading combination of significant skin clearance with demonstrated tolerability in a once daily pill in Phase 3 topline results. Retrieved November 19, 2024 from https://www.prnewswire.com/news-releases/icotrokinra-delivered-an-industry-leading-combination-of-significant-skin-clearance-with-demonstrated-tolerability-in-a-once-daily-pill-in-phase-3-topline-results-302309034.html

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