NEJM Reports JNJ-2113 Efficacy and Safety in Phase 2b Psoriasis Trial

Protagonist Therapeutics has reported that its drug candidate, JNJ-2113, has successfully met all primary and secondary goals in a Phase 2b clinical trial for treating moderate-to-severe plaque psoriasis. The oral peptide inhibitor of the IL-23 receptor demonstrated significant efficacy and is now being tested in Phase 3 trials within the ICONIC-program.

The Phase 2b FRONTIER 1 trial, published in the New England Journal of Medicine, involved 255 participants who were randomly assigned to six treatment groups. The study aimed to evaluate the drug's efficacy and safety, with the primary endpoint being a 75% reduction in Psoriasis Area and Severity Index score (PASI-75) at Week 16. The highest dose of JNJ-2113 resulted in a 79% PASI-75 response rate at Week 16. Additionally, 59.5% of patients achieved a PASI-90 response, and 40.5% achieved a PASI-100 response.

JNJ-2113 also showed a positive impact on Investigator's Global Assessment (IGA) scores, with 64.3% of patients at the highest dose achieving a score of 0/1, indicating cleared or minimal skin lesions. Improvements in Patient-Reported Outcomes were noted, as measured by the Psoriasis Symptoms and Signs Diary and the Dermatology Life Quality Index.

Furthermore, JNJ-2113 was associated with reduced serum levels of human beta-defensin 2 (hBD-2), a biomarker of disease activity, with the lowest levels observed at the 100 mg twice-daily dose. The safety profile of JNJ-2113 was comparable to placebo, with a similar proportion of patients experiencing adverse events.

Protagonist's President and CEO, Dinesh V. Patel, expressed satisfaction with the clinical success of JNJ-2113 and its potential to address unmet needs in psoriasis and other IL-23 pathway mediated diseases. The drug is also being studied in a Phase 2b ANTHEM-UC trial for ulcerative colitis.

Plaque psoriasis is a condition that affects millions of people globally, with a significant portion experiencing moderate-to-severe symptoms that can greatly impact their daily life. The positive results from the NEJM publication and the ongoing clinical trials are promising for the future treatment of this condition.

Protagonist Therapeutics is a biopharmaceutical company that develops peptide-based new chemical entities, with rusfertide and JNJ-2113 being in advanced stages of clinical development. The company has a collaboration agreement with Johnson & Johnson for the development and commercialization of JNJ-2113, which is being further studied in a range of indications.