Johnson & Johnson (JNJ.US) oral IL-23R antagonist achieves positive key results in two Phase III studies.

On November 18th, Johnson & Johnson (JNJ.US) announced that the Phase III ICONIC-LEAD study of the oral IL-23R antagonist Icotrokinra (JNJ-2113) for the treatment of plaque psoriasis (PsO) had achieved positive key results. This is the first oral IL-23R targeted drug to successfully complete Phase III studies. The ICONIC-LEAD study is a global, multicenter, randomized, double-blind, placebo-controlled clinical trial (n=684, including 66 adolescents), evaluating the safety and efficacy of Icotrokinra compared to placebo in patients aged 12 and older with moderate to severe plaque psoriasis. In this study, the safety data of Icotrokinra was consistent with the results observed in previous Phase II studies (FRONTIER 1 and FRONTIER 2 studies). The proportion of patients experiencing adverse events (AE) in the Icotrokinra group and placebo group was similar, with 49.3% and 49.1% of patients experiencing treatment-emergent adverse events (TEAE) at week 16. In addition, the Phase III ICONIC-TOTAL study of Icotrokinra for the treatment of plaque psoriasis at specific sites (scalp, genitalia, and/or palms and soles of the feet) also yielded positive results. The results showed that at week 16 of treatment, the proportion of patients achieving an IGA score of 0/1 was higher in the Icotrokinra group compared to the placebo group. Johnson & Johnson stated that detailed data from these two studies will be presented at an upcoming medical conference, and they plan to submit them to regulatory authorities.