▎WuXiEdited by Kant Content Team

Recently, Johnson & Johnson announced the first set of data from the long-term extension study FRONTIER 2 of the Phase 2b clinical trial FRONTIER 1 for JNJ-2113, an antagonistic peptide targeting the IL-23 receptor (IL-23R) co-developed with Protagonist Therapeutics. The results showed,JNJ-2113 Maintains High Skin Clearance Rates for 52 Weeks in Adult Patients with Moderate to Severe Plaque Psoriasis (PsO), According to a Press Release，JNJ-2113 is the first investigational targeted oral peptide designed to block IL-23R.

FRONTIER 1 Study Published in 2023ResultsDisplay,At week 16, patients receiving JNJ-2113 treatment reachedProportion of subjects with at least 75% improvement in Psoriasis Area and Severity Index (PASI)The proportion of patients achieving PASI 75 (primary endpoint), as well as PASI 90 and PASI 100, exceeded that of the placebo group.

The results of the FRONTIER 2 study announced this time show,The sustained efficacy and safety outcomes of patients receiving JNJ-2113 from Week 16 to Week 52 were consistent with the data reported in the FRONTIER 1 study.Using PASI as the evaluation criterion,The response rates in the 5 JNJ-2113 treatment groups were sustained from Week 16 through Week 52.The PASI 75 response rate was highest in the group receiving 100 mg twice daily (78.6% at Week 16 and 76.2% at Week 52).All primary and secondary endpoint results of the five JNJ-2113 treatment groups were maintained from Week 16 to Week 52.

The safety of the FRONTIER 2 study was consistent with FRONTIER 1. In the JNJ-2113 treatment group, 58.6% of patients experienced adverse events (AEs), with no evidence suggesting a dose-related increase in AEs (including gastrointestinal disturbances). The most commonly reported AEs were nasopharyngitis (18.1%), upper respiratory tract infection (9.7%), and COVID-19 (5.3%).

Currently, multiple pivotal Phase 3 clinical trials of JNJ-2113 for the treatment of moderate to severe plaque psoriasis (PsO) are underway, aiming to evaluate the safety and efficacy of JNJ-2113 as a monotherapy or in combination with the selective TYK2 inhibitor deucravacitinib in adult patients with moderate to severe plaque PsO.

In addition,The results of the FRONTIER 1 and FRONTIER 2 studies indicate that JNJ-2113 has the potential to treat other IL-23-mediated diseases.Therefore, Johnson & Johnson initiated the Phase 2b ANTHEM-UC study to evaluate the safety and efficacy of JNJ-2113 compared to placebo in patients with moderate to severe active ulcerative colitis.

IL-23 Plays a Key Role in the Pathogenic T Cell Activation in Moderate to Severe Plaque Psoriasis, and is the Basis of Inflammatory Responses in Psoriasis and Other Skin Diseases, Rheumatism, and IL-23-Mediated Gastrointestinal Diseases.JNJ-2113 can bind to IL-23R with single-digit picomolar affinity and potently inhibit IL-23 signaling in human T cells with selectivity.In 2017, Janssen Biotech reached a nearly $1 billion collaboration agreement with Protagonist Therapeutics to jointly develop oral therapies targeting IL-23R.

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