Janssen Announces Positive One-Year Data from Phase 2b Trial of Oral IL-23R Antagonist JNJ-2113 in Moderate-to-Severe Plaque Psoriasis

March 8, 2024Johnson & Johnson announced the first batch 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.

Results Show JNJ-2113 Maintained High Skin Clearance Rates for 52 Weeks in Adult Patients with Moderate to Severe Plaque Psoriasis (PsO). JNJ-2113 is the first investigational targeted oral peptide designed to block IL-23R.

The FRONTIER 1 study published in 2023ResultsThe results showed that at Week 16, the proportion of patients receiving JNJ-2113 who achieved at least a 75% improvement in the Psoriasis Area and Severity Index (PASI) (PASI 75, primary endpoint), as well as the proportions of patients achieving PASI 90 and PASI 100, exceeded those in the placebo group.

The results of the FRONTIER 2 study, released this time, show that the sustained efficacy and safety outcomes from week 16 to week 52 in patients treated with JNJ-2113 are consistent with the data reported in the FRONTIER 1 study. Using PASI as the evaluation criterion, the response rates of the five JNJ-2113 treatment groups remained consistent from week 16 to week 52, with the highest PASI 75 response rate observed in the group receiving 100 mg twice daily (78.6% at week 16 and 76.2% at week 52). The primary secondary endpoint results of all five JNJ-2113 treatment groups also remained consistent 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 that the increase in AEs (including gastrointestinal disturbances) was dose-related. The most commonly reported AEs were nasopharyngitis (18.1%), upper respiratory tract infection (9.7%), and COVID-19 (5.3%).

AboutPlaque PsoriasisPsoriasis

Plaque psoriasis is an immune disease where skin cells are overproduced, leading to inflammatory, scaly plaques that may cause itching or pain. It is estimated that more than 125 million people worldwide suffer from this condition. Among all plaque psoriasis patients, nearly a quarter have moderate to severe cases.

AboutJNJ-2113

JNJ-2113 is a novel oral IL-23R antagonistic peptide that can be absorbed orally and binds to IL-23R with high affinity. The IL-23/IL-23R signaling pathway plays a crucial role in the pathogenesis of immune-mediated inflammatory diseases, including psoriasis. JNJ-2113 can selectively and potently block the IL-23 signaling pathway and the production of downstream inflammatory cytokines.

About Johnson & Johnson

Johnson & Johnson was founded in 1886 and is one of the most comprehensive healthcare enterprises globally, with a wide range of business operations across three major fields: medical devices, pharmaceuticals, and consumer products. Headquartered in New Brunswick, New Jersey, USA, the company has over 260 operating companies in more than 60 countries and regions worldwide, with more than 130,000 employees globally. In 2020, its global revenue reached $82.6 billion, with global R&D investment amounting to $12.2 billion.