Johnson & Johnson Announces Phase II Clinical Data of Oral IL-23R Inhibitor JNJ-77242113 for Moderate-to-Severe Plaque Psoriasis

On July 4, Johnson & Johnson presented the Phase II FRONTIER 1 study (NCT05223868) data on the oral IL-23R inhibitor JNJ-77242113 (PN-235) for the treatment of moderate to severe plaque psoriasis at the 25th World Congress of Dermatology.

FRONTIER 1 is a randomized, double-blind, placebo-controlled Phase II clinical trial designed to evaluate the efficacy and safety of JNJ-77242113 in adult patients with moderate to severe plaque psoriasis. The study enrolled 255 participants who were randomly assigned in a 1:1:1:1:1:1 ratio to receive JNJ-77242113 (25mg QD, 50mg QD, 100mg QD, 25mg BID, 100mg BID) or placebo for 16 weeks. The primary endpoint was the proportion of patients achieving ≥75% improvement in the Psoriasis Area and Severity Index at Week 16 (PASI75).

The results showed that, at Week 16, the proportion of patients achieving PASI75 in the JNJ-77242113 treatment groups was as follows: 25mg QD 37.2%, 50mg QD 58.1%, 25mg BID 51.2%, 100mg QD 65.1%, 100mg BID 78.6%, and 9.3% in the placebo group.

The proportion of patients achieving PASI90 at Week 16 was: 25.6% in the JNJ-77242113 25mg QD group, 51.2% in the 50mg QD group, 26.8% in the 25mg BID group, 46.5% in the 100mg QD group, 59.5% in the 100mg BID group, and 2.3% in the placebo group.

In terms of safety, the proportion of patients experiencing adverse events in the JNJ-77242113 and placebo groups was comparable. The most common adverse events were COVID-19 and nasopharyngitis, with no dose-dependent trend observed.

JNJ-77242113 is an oral IL-23R inhibitor developed by Protagonist Therapeutics. In July 2021, Johnson & Johnson reached an agreement with Protagonist to co-develop three oral IL-23R inhibitors, including JNJ-77242113.

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