JNJ-2113: A Promising Oral Treatment for Moderate-to-Severe Psoriasis Shows Positive Phase 2b Results

A recent publication in the New England Journal of Medicine highlighted the positive results from the Phase 2b FRONTIER 1 clinical trial of JNJ-2113, an oral peptide that selectively targets the IL-23 receptor. This innovative treatment has shown promise for patients suffering from moderate-to-severe plaque psoriasis (PsO), a condition characterized by an overactive immune system that accelerates skin cell growth, leading to inflammation and the formation of plaques and scales on the skin.

The FRONTIER 1 trial was a significant milestone in PsO research, demonstrating that JNJ-2113 met its primary endpoint, which was a substantial reduction in the Psoriasis Area and Severity Index score (PASI 75 response) at Week 16. Notably, 79% of the patients in the highest tested dose group showed this improvement. Moreover, 40.5% of patients achieved a PASI 100 response, and 45.2% achieved an Investigator's Global Assessment (IGA) score of 0, indicating clear skin.

The study also reported improvements in Patient Reported Outcomes, showing that patients who received JNJ-2113 experienced a significant reduction in disease-related symptoms by Week 16. This was assessed using the Psoriasis Symptoms and Signs Diary (PSSD), which measures the severity of symptoms like itch, skin tightness, and pain associated with PsO.

In terms of safety, the rates of adverse events were comparable between the JNJ-2113 and placebo groups, with no observed relationship between the dose of JNJ-2113 and the occurrence of adverse events or serious adverse events. The most common adverse events included COVID-19 infection, nasopharyngitis, and upper respiratory tract infection, among others.

Furthermore, JNJ-2113 was associated with lower serum levels of human beta-defensin 2 (hBD-2), an indicator of inhibition of the IL-17/IL-23 axis, which is a key pathway in the inflammatory response associated with PsO.

The potential of JNJ-2113 extends beyond PsO, as the compound may also be effective in treating other IL-23-mediated diseases. The Phase 2b ANTHEM-UC study has been initiated to evaluate the safety and effectiveness of JNJ-2113 in participants with ulcerative colitis, another condition influenced by the IL-23 pathway.

The Phase 3 ICONIC clinical development program for JNJ-2113 in adult and adolescent patients with moderate-to-severe plaque PsO has already begun, with studies ICONIC-LEAD and ICONIC-TOTAL launched in Q4 2023. These studies aim to further evaluate the safety and efficacy of JNJ-2113.

The development of JNJ-2113 represents a significant step forward in the treatment of PsO, offering a potential oral therapeutic option that could improve both clinical outcomes and the quality of life for patients. With ongoing research and clinical trials, the future of PsO treatment looks promising.