J&J/Protagonist's icotrokinra promising in phase 3 psoriasis trial

Johnson & Johnson (J&J) and Protagonist Therapeutics have unveiled promising data from their collaborative research on an investigational oral peptide intended for treating plaque psoriasis. The results, presented at the American Academy of Dermatology (AAD) annual conference, highlight the potential of icotrokinra (JNJ-2113) in managing this challenging skin condition. The phase 3 ICONIC-LEAD study assessed the efficacy of icotrokinra in individuals aged 12 and older with moderate-to-severe plaque psoriasis, showing significant skin improvement.

Plaque psoriasis, a chronic immune-mediated skin disorder, affects an estimated 125 million individuals globally. It results in red, scaly, and sometimes painful skin patches that can occur anywhere on the body. The condition stems from complex immune system interactions, notably involving the IL-23 receptor, which icotrokinra targets to mitigate the disease's effects.

The ICONIC-LEAD study revealed that after 16 weeks of treatment, 65% of participants receiving daily doses of icotrokinra achieved either clear or almost clear skin according to the Investigator's Global Assessment (IGA), while 50% showed a 90% improvement in the Psoriasis Area and Severity Index (PASI 90). This is in stark contrast to the placebo group, where only 8% reached the IGA benchmark and 4% achieved PASI 90. The benefits of icotrokinra continued to increase at the 24-week mark, with 74% of treated patients achieving an IGA score of zero or one, and 65% reaching PASI 90. Additionally, 46% achieved complete skin clearance (IGA zero), with 40% reaching PASI 100.

Dr. Robert Bissonnette from Innovaderm Research, who participated in the study, noted the promising nature of these results, emphasizing icotrokinra’s potential as a once-daily oral treatment that combines effective skin clearance with a favorable safety profile.

Further data from the ICONIC-ADVANCE 1 and 2 studies were also shared. These studies are comparing icotrokinra to both a placebo and deucravacitinib, another treatment for moderate-to-severe plaque psoriasis. Importantly, a groundbreaking head-to-head study has commenced, aiming to establish the superiority of icotrokinra, an oral treatment, over injectable biologics, which are commonly used in psoriasis management.

Icotrokinra is the result of a joint discovery and development effort between Protagonist Therapeutics and J&J, under a licensing and collaboration agreement. This partnership grants J&J exclusive rights to advance icotrokinra through mid-stage clinical trials and beyond, as well as to commercialize the drug for a wide range of indications based on the research outcomes.

This development adds a new dimension to the management of plaque psoriasis, offering hope for a treatment that is not only effective but also more convenient for patients compared to injectable options. The ongoing studies and the strategic collaboration between J&J and Protagonist Therapeutics could pave the way for innovative treatments that improve the quality of life for millions of people affected by psoriasis and similar inflammatory conditions. As research continues, the potential of icotrokinra to transform psoriasis care is eagerly anticipated by the medical community.