The Janssen Pharmaceutical Companies of Johnson & Johnson have released positive topline results from a Phase 2b clinical trial called FRONTIER 1. The trial evaluated the efficacy of a novel oral interleukin-23 receptor (IL-23R) antagonist peptide called JNJ-2113 in adult patients with moderate-to-severe plaque psoriasis (PsO). The trial successfully met all primary and secondary efficacy endpoints, showing that a higher proportion of patients treated with JNJ-2113 achieved significant improvement in their skin lesions compared to those who received a placebo. The improvements were measured using the Psoriasis Area and Severity Index (PASI), specifically PASI 75, PASI 90, and PASI 100, which indicate different levels of improvement.
JNJ-2113 is an oral therapy that effectively blocks the IL-23 signaling pathway and reduces the production of inflammatory cytokines. This pathway plays a critical role in the development of immune-mediated inflammatory diseases, including psoriasis. The positive results from the Phase 2b trial support the progression of JNJ-2113 into Phase 3 clinical development for the treatment of moderate-to-severe plaque psoriasis in adult patients.
Plaque psoriasis is a condition characterized by the overproduction of skin cells, resulting in inflamed and scaly plaques that can cause discomfort and itching. It affects millions of people globally, with a significant portion of cases considered moderate to severe. Existing treatments for psoriasis often involve injectable biologics. The development of an oral therapy like JNJ-2113, which directly targets the IL-23 receptor, offers potential advantages in terms of patient preference and convenience.
The discovery and development of JNJ-2113, previously known as PN-235, stemmed from a license and collaboration agreement between Protagonist Therapeutics and Janssen Biotech, Inc. Janssen has exclusive worldwide rights to develop JNJ-2113 in Phase 2 clinical trials and beyond, as well as to commercialize other compounds resulting from the collaboration for various indications. The agreement, established in 2017, aimed to facilitate the discovery and development of innovative compounds, leading to the creation of JNJ-2113.
These positive results represent a significant advancement in the treatment of moderate-to-severe plaque psoriasis. The development of JNJ-2113 as an oral therapy specifically targeting the IL-23 pathway offers potential benefits in terms of patient preference and treatment accessibility. Further research in Phase 3 clinical trials will provide more insights into the efficacy and safety of JNJ-2113 for psoriasis patients.