Workflow
J&J Oral Psoriasis Drug Meets Primary Goal in Late-Stage Study
J&JJ&J(US:JNJ) ZACKSยท2025-05-12 13:15

Core Insights - Johnson & Johnson (J&J) announced positive results from the phase III ICONIC-TOTAL study for its investigational oral peptide, icotrokinra, aimed at treating plaque psoriasis in patients with moderate severity affecting sensitive areas [1][7]. Study Results - The study met its primary endpoint, with 57% of patients treated with icotrokinra achieving significant skin clearance compared to only 6% in the placebo group, as measured by the Investigator's Global Assessment (IGA) [2]. - In specific subgroups, 66% of patients with scalp psoriasis achieved clear or almost clear skin with icotrokinra versus 11% in the placebo group; 77% of patients with genital psoriasis achieved significant clearance compared to 21% in the placebo group; and 42% of patients in the hand/foot subgroup achieved clearance compared to 26% in the placebo group [4]. Stock Performance - Year to date, J&J's shares have increased nearly 7%, contrasting with a 6% decline in the industry [5]. Development and Collaboration - Icotrokinra is being developed in collaboration with Protagonist Therapeutics, with J&J holding exclusive worldwide rights for development beyond phase II studies [7]. - The ICONIC-TOTAL study is part of a broader late-stage ICONIC clinical program evaluating icotrokinra for psoriasis and psoriatic arthritis [8]. Additional Studies and Comparisons - J&J and Protagonist have reported positive results from two other phase III studies, ICONIC-ADVANCE 1 and 2, which demonstrated icotrokinra's superiority over Bristol Myers' psoriasis drug, Sotyktu [9]. - A phase III ICONIC-ASCEND study has been initiated to compare icotrokinra with J&J's own drug Stelara, aiming to provide a more convenient treatment option [10]. Market Potential - J&J believes icotrokinra has the potential to achieve peak non-risk-adjusted operational sales of $5 billion, with ongoing exploration of its use in inflammatory bowel disease [11].