JNJ-2113, the First Oral IL-23R Antagonist Co-Developed by Janssen and Protagonist Therapeutics, Achieves Positive Topline Results in Phase IIb Trial for Moderate-to-Severe Plaque Psoriasis

On March 7, Protagonist Therapeutics announced positive results from the Phase IIb FRONTIER 1 study of JNJ-2113, an IL-23 receptor antagonist developed in collaboration with Janssen Pharmaceuticals, a Johnson & Johnson company, for the treatment of moderate to severe plaque psoriasis, meeting the primary endpoint.

FRONTIER 1 is a randomized, multicenter, double-blind, placebo-controlled Phase IIb study. A total of 255 patients were enrolled to receive JNJ-2113 orally three times daily or twice daily. The primary endpoint was the proportion of patients achieving PASI-75 (at least 75% improvement in the Psoriasis Area and Severity Index) at week 16.

Results showed that, compared with the placebo group, the proportion of PASI-75 patients significantly increased in all JNJ-2113 treatment groups at different doses, with a clear dose-response observed within an eight-fold dose range. Moreover, the drug was well-tolerated, and the incidence of adverse events in the treatment groups showed no significant difference compared to the placebo group; specific data will be disclosed at a medical conference in Q2 2023.

JNJ-2113 is an oral IL-23 receptor antagonist. In May 2017, Janssen and Protagonist Therapeutics entered into an exclusive license collaboration agreement to jointly develop an oral IL-23 receptor antagonist. In December 2021, Protagonist and Janssen decided to designate PN-235 as the candidate drug.

According to the agreement, if JNJ-2113 enters Phase III research and achieves the primary endpoint, Protagonist will receive milestone payments of $50 million and $115 million. In total, Protagonist is eligible to receive up to $855 million in milestone payments and tiered royalties on global net sales of the drug.

Currently, Johnson & Johnson has two IL-23 pathway products: ustekinumab, an anti-IL-12/IL-23 monoclonal antibody, and guselkumab, an anti-IL-23 monoclonal antibody. Among them, ustekinumab has shown very robust performance, steadily increasing, with sales reaching $9.723 billion in 2022, just a step away from becoming a $10 billion blockbuster. For the IL-23 pathway, Johnson & Johnson's development strategy is to develop oral IL-23 receptor antagonists and other oral products targeting the IL-23 pathway based on the company’s existing assets, aiming to further improve patient compliance.

Dr. Dinesh V. Patel, President and Chief Executive Officer of Protagonist Therapeutics, said, "JNJ-2113 is the first and only oral IL-23 receptor antagonist in its class, with the potential to serve as an oral targeted treatment for plaque psoriasis, further highlighting the strength of our innovative peptide technology. Based on the above data, we look forward to JNJ-2113 advancing into Phase III registrational studies for plaque psoriasis as soon as possible."

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