Icotrokinra Shows Promising Skin Improvement and Safety in Phase 3 Trials

Johnson & Johnson (NYSE: JNJ) has revealed encouraging topline findings from the ICONIC-LEADa study, a crucial Phase 3 trial evaluating icotrokinra (JNJ-2113). This compound is the first targeted oral peptide designed to selectively inhibit the IL-23 receptor in individuals aged 12 and older who suffer from moderate to severe plaque psoriasis (PsO). The Phase 3 trial successfully achieved its co-primary endpoints, including the Psoriasis Area and Severity Index (PASI) 90b and Investigator's Global Assessment (IGA) scores of 0/1c at the 16-week mark, with response rates continuing to show improvement up to week 24.

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Once-daily icotrokinra demonstrated notable skin improvement compared to placebo in adults and teenagers suffering from moderate to severe plaque psoriasis. By week 16, almost two-thirds (64.7%) of individuals receiving icotrokinra achieved IGA scores of 0/1 (indicating clear or almost clear skin), while 49.6% attained PASI 90; in contrast, these figures for the placebo group were 8.3% and 4.4%, respectively.1 Response rates continued to rise by week 24, with 74.1% of icotrokinra-treated patients reaching IGA scores of 0/1 and 64.9% achieving PASI 90.1 Safety results were in line with those observed in the Phase 2 FRONTIER 1 and 2 trials, showing comparable occurrences of adverse events (AEs) between the icotrokinra and placebo groups, with 49.3% and 49.1% of patients, respectively, reporting treatment emergent adverse events (TEAEs) at week 16. 

Additionally, favorable topline outcomes from the Phase 3 ICONIC-TOTALd study indicated that the once-daily dosage of icotrokinra successfully met the primary goal of achieving IGA scores of 0/1 at week 16 when compared to placebo. Detailed findings from ICONIC-LEAD and ICONIC-TOTAL are being compiled for forthcoming medical conferences and will be submitted to health authorities shortly.

“We are thrilled to observe remarkable Phase 3 findings with once-daily icotrokinra treatment, consistent with our Phase 2 trial of this pioneering targeted oral peptide that specifically inhibits the IL-23 receptor,” stated Liza O’Dowd, Vice President and Lead of the Immunodermatology Disease Area at Johnson & Johnson Innovative Medicine. “A significant number of patients dealing with moderate to severe plaque psoriasis qualify for, yet do not receive, advanced treatment options. Icotrokinra holds the promise of providing a once-daily oral therapy that may meet the needs and preferences of individuals affected by plaque psoriasis.”

Further investigations within the Phase 3 ICONIC clinical development program are ongoing, encompassing ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2, which will assess the safety and effectiveness of icotrokinra against both placebo and deucravacitinib in moderate to severe plaque psoriasis. The Phase 3 ICONIC-PsA initiative, focusing on psoriatic arthritis, is set to commence in early 2025.

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According to the data provided by the Synapse Database, As of November 25, 2024, there are 10 investigational drugs for the IL-23R target, including 16 indications, 14 R&D institutions involved, with related clinical trials reaching 31, and as many as 2277 patents.

Icotrokinra is a synthetic peptide drug that targets IL-23R and is being developed for the treatment of a variety of therapeutic areas, including immune system diseases, skin and musculoskeletal diseases, other diseases, and digestive system disorders.