Johnson & Johnson Achieves Phase II Success for Oral Peptide in Psoriasis Treatment

Johnson & Johnson has recently reported positive one-year data from the Phase IIb FRONTIER 2 trial for their investigational peptide, JNJ-2113, which is being studied for the treatment of moderate-to-severe plaque psoriasis. The data was shared at the American Academy of Dermatology’s Annual Meeting. The results showed that a significant percentage of patients treated with the highest dosage of JNJ-2113 maintained a substantial improvement in their skin condition, as measured by the Psoriasis Area and Severity Index (PASI). Notably, the treatment was well-tolerated, with serious side effects being rare.

At the 52-week mark, 76.2% of patients on the 100-mg, twice-daily dosage maintained a PASI-75 response, which indicates a 75% improvement from baseline. This is a slight decrease from the 78.6% PASI-75 response observed at 16 weeks. The treatment also sustained higher PASI-100 responses, which suggest a 100% improvement, at a stable rate of 40.5% from weeks 16 to 52 across all treatment groups. Additionally, the PASI-90 response, indicating a 90% improvement, rose from 59.5% at 16 weeks to 64.3% at 52 weeks.

The treatment's safety profile was also a highlight of the study, with JNJ-2113 demonstrating a good overall tolerance. While 58.6% of patients experienced adverse events, only 4% had serious side effects, which were found to be unrelated to the treatment.

JNJ-2113 is an oral peptide therapeutic that targets the IL-23 receptor to reduce inflammation and potentially address the root cause of plaque psoriasis. The development of this treatment is a collaboration between Johnson & Johnson and Protagonist Therapeutics, who first partnered in 2017 and have since amended their agreement to advance the development of oral IL-23 receptor agonists. Johnson & Johnson is leading the ongoing Phase III ICONIC program, which includes the ICONIC-ADVANCE 2 study. This study aims to enroll approximately 675 patients and will compare JNJ-2113 with Bristol Myers Squibb’s Sotyktu.

The positive results from the Phase IIb FRONTIER 2 trial are a step forward for JNJ-2113, especially considering the initial disappointment from the Phase IIb FRONTIER 1 study results released in July 2023. The new data suggest that JNJ-2113 could offer a novel, durable, and convenient treatment option for patients with psoriasis, addressing a significant unmet need in the field.