Core Insights - Johnson & Johnson has submitted an application to the European Medicines Agency (EMA) for icotrokinra, a first-in-class investigational oral peptide targeting the IL-23 receptor for treating moderate-to-severe plaque psoriasis in patients aged 12 and older [1][2][4]. Group 1: Clinical Development and Efficacy - The application is based on data from four Phase 3 studies, including ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2, which met all primary and co-primary endpoints [1][6][8]. - Icotrokinra demonstrated significant skin clearance and a favorable safety profile, achieving co-primary endpoints of Investigator's Global Assessment (IGA) score of 0/1 and Psoriasis Area and Severity Index (PASI) 90 compared to placebo [6][7][13]. - The ICONIC-ADVANCE studies showed superiority of icotrokinra over deucravacitinib in patients with moderate-to-severe psoriasis [1][6][13]. Group 2: Safety Profile - Pooled safety data indicated that 49.1% of patients treated with icotrokinra experienced adverse events, compared to 51.9% in the placebo group, with no new safety signals identified [1][6][8]. - The safety profile of icotrokinra is considered favorable relative to comparators, supporting its potential as a treatment option [2][4]. Group 3: Future Studies and Research - Johnson & Johnson has initiated the Phase 3 ICONIC-ASCEND study, which aims to demonstrate the superiority of icotrokinra compared to the injectable biologic ustekinumab and placebo [4][10]. - Long-term data from the ICONIC development program, including at least 52 weeks of treatment, is being prepared for future presentations [6][8]. Group 4: Market Context - Plaque psoriasis affects approximately 6.4 million people in Europe and over 125 million globally, with nearly one-quarter of cases classified as moderate-to-severe [9][10]. - The burden of plaque psoriasis extends beyond physical symptoms, impacting emotional health and quality of life [9][10].

Core Insights - Johnson & Johnson has submitted a New Drug Application (NDA) for icotrokinra, a first-in-class oral peptide targeting the IL-23 receptor, aimed at treating moderate-to-severe plaque psoriasis in patients aged 12 and older [1][2][6] - The NDA is supported by data from four pivotal Phase 3 studies, demonstrating significant skin clearance and a favorable safety profile, with icotrokinra showing superiority over deucravacitinib [1][2][4] - The treatment offers a once-daily pill option, which may shift the treatment paradigm for plaque psoriasis patients [1][2][5] Phase 3 Studies Overview - The ICONIC clinical development program includes studies such as ICONIC-LEAD, ICONIC-TOTAL, ICONIC-ADVANCE 1, and ICONIC-ADVANCE 2, all of which met primary and co-primary endpoints [1][4][6] - ICONIC-LEAD involved 684 participants, showing significant improvements in skin conditions compared to placebo [3][4] - ICONIC-ASCEND is the first head-to-head study comparing icotrokinra with ustekinumab, an injectable biologic, marking a significant advancement in psoriasis research [2][4] Efficacy and Safety Data - Results from the ICONIC-ADVANCE studies confirmed icotrokinra's efficacy, achieving co-primary endpoints of Investigator's Global Assessment (IGA) score of 0/1 and Psoriasis Area and Severity Index (PASI) 90 [2][3][4] - Safety data pooled from all studies indicated a similar proportion of adverse events between icotrokinra (49.1%) and placebo (51.9%), with no new safety signals identified [1][2][4] Patient Impact and Market Potential - Approximately 8 million Americans and over 125 million people globally suffer from plaque psoriasis, with nearly one-quarter experiencing moderate-to-severe cases [5][6] - The introduction of icotrokinra could significantly improve the quality of life for patients, particularly those with difficult-to-treat areas such as the scalp and genitals [2][5][6] - The innovative oral formulation may appeal to patients seeking more convenient treatment options compared to traditional injectables [1][2][5]

Core Insights - The investigational drug icotrokinra has shown promising results in treating moderate-to-severe plaque psoriasis, with nearly half of patients achieving complete skin clearance at Week 24 in the Phase 3 ICONIC-LEAD study [1][2][4] - Johnson & Johnson is initiating the first head-to-head study comparing icotrokinra, an oral medication, to the injectable biologic ustekinumab, marking a significant step in psoriasis treatment research [1][3][4] Study Results - In the ICONIC-LEAD study, 65% of patients treated with icotrokinra achieved an Investigator's Global Assessment (IGA) score of 0/1 (clear or almost clear skin) at Week 16, with 50% achieving a Psoriasis Area and Severity Index (PASI) 90 response, compared to only 8% and 4% in the placebo group respectively [2][5] - By Week 24, 74% of patients on icotrokinra reached IGA 0/1, and 65% achieved PASI 90, with 46% achieving complete skin clearance (IGA 0) and 40% reaching PASI 100 [2][5] Safety Profile - The safety profile of icotrokinra appears favorable, with similar rates of adverse events (AEs) reported between the icotrokinra (49%) and placebo groups (49%), and no new safety signals identified [2][3] Future Studies - The positive outcomes from the ICONIC-ADVANCE studies, which also met their co-primary endpoints, have led to the initiation of the ICONIC-ASCEND study, further exploring the efficacy of icotrokinra against ustekinumab [3][4] Drug Mechanism - Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor, which is crucial in the inflammatory response associated with moderate-to-severe plaque psoriasis [1][10]