Icotrokinra

Bengaluru: Johnson & Johnson said on Friday its experimental psoriasis drug met the main goal of a late-stage study, as the once-daily pill helped patients achieve clear or almost clear skin. The drugmaker has been working on more convenient treatment options as its injectable psoriasis drug Stelara, which gained over $10 billion in sales last year, faces stiff competition from cheaper rivals. J&J said last month it expects the drug, icotrokinra , to generate sales of $700 million in 2028. BTIG analyst Julian Harrison expects icotrokinra to "complement rather than disrupt" market leaders, including J&J's Tremfya and AbbVie's Skyrizi. Icotrokinra helped 66 per cent of patients with scalp psoriasis and 77 per cent of those with genital psoriasis achieve significantly clear skin compared to 11 per cent and 21 per cent success rate in patients on placebo, respectively, J&J said. The drug was administered to patients 12 years and older with at least moderate plaque psoriasis affecting "high-impact" areas, including the scalp and genitals, for 16 weeks. Plaque psoriasis, an immune-mediated condition characterized by thick, scaly patches or plaques, is the most common type of psoriasis. Psoriasis is estimated to affect more than 7.5 million adults in the United States. The study enrolled 311 patients, who were randomly chosen to receive either icotrokinra or placebo for a period of 16 weeks. J&J is developing the drug with partner Protagonist Therapeutics. Icotrokinra is designed to block a protein, IL-23, involved in inflammatory responses and is being tested as a potential treatment for other inflammatory conditions, such as ulcerative colitis. In a separate late-stage study last year, the drug showed significant skin clearance in patients with moderate-to-severe plaque psoriasis. (Reporting by Mariam Sunny and Padmanabhan Ananthan in Bengaluru; Editing by Vijay Kishore and Shinjini Ganguli)

66% of patients with scalp psoriasis and 77% with genital psoriasis treated with investigational icotrokinra achieved site-specific clear or almost clear skin at Week 16 Icotrokinra continues to demonstrate a standout combination of significant skin clearance (IGA 0/1) and a favorable safety profile in a once daily pill SPRING HOUSE, PA, USA I May 9, 2025 I Johnson & Johnson (NYSE: JNJ ) today announced new data from the Phase 3 ICONIC-TOTAL a study investigating icotrokinra (JNJ-2113), the first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor. The study evaluated adults and adolescents 12 years of age and older with body surface area as low as 1% and at least moderate plaque psoriasis (PsO) affecting high-impact skin sites. Data presented at the 2025 Society for Investigative Dermatology (SID) Annual Meeting show 57% of patients treated with once daily icotrokinra achieved the study’s primary endpoint with an Investigator’s Global Assessment (IGA) b score of 0/1 (clear or almost clear skin) and a ≥2-grade improvement from baseline at Week 16 compared to 6% of patients receiving placebo (P<0.001). 1 Icotrokinra demonstrated high rates of skin clearance in patients with scalp psoriasis as 66% achieved a scalp-specific Investigator’s Global Assessment (ss-IGA) c score of 0/1 compared to 11% receiving placebo (P<0.001) at Week 16. At the same time point, among patients with genital psoriasis, 77% treated with icotrokinra achieved a static Physician’s Global Assessment of Genitalia (sPGA-G) d score of 0/1 compared to 21% receiving placebo (P<0.001). i In the smaller subset of patients with hand/foot psoriasis, treatment with icotrokinra showed a numerically higher rate of skin clearance at Week 16 with 42% achieving a hand and/or foot Physician’s Global Assessment (hf-PGA) e score of 0/1 compared to 26% receiving placebo. “While plaque psoriasis can appear in any location on the body, most high-impact skin sites affect areas critical for mobility, personal care, and intimacy, and can be very challenging to treat effectively. Notably, almost 80% of psoriasis patients experience scalp involvement,” said Melinda Gooderham, MSc, MD, FRCPC, SKiN Centre for Dermatology, Queen’s University, and Probity Medical Research, Peterborough, ON, Canada and ICONIC-TOTAL study investigator. f “Results from the ICONIC-TOTAL study demonstrate impressive rates of skin clearance in these difficult-to-treat areas and show the potential for treatment with icotrokinra to offer patients a novel therapeutic option that aligns with their treatment needs and preferences.” Icotrokinra demonstrated a favorable safety profile. A similar proportion of patients experienced adverse events (50% and 42%) and serious adverse events (0.5% and 1.9%) in icotrokinra and placebo respectively through Week 16, with no new safety signals identified. 1 “When plaque psoriasis affects sensitive areas of the body, patients often experience unique challenges that can have a profound impact on their daily lives,” said Liza O’Dowd, MD, Vice President, Immunodermatology Disease Area Lead, Johnson & Johnson Innovative Medicine. “These new findings build upon the impressive scalp psoriasis results seen in ICONIC-LEAD and strengthen the breadth of data demonstrating the potential for icotrokinra to shift the treatment paradigm in moderate-to-severe plaque psoriasis, by offering a combination of skin clearance and favorable safety in a once daily pill.” Editor’s notes: a.      ICONIC-TOTAL is a Phase 3 randomized controlled trial (RCT) evaluating the efficacy and safety of icotrokinra compared with placebo for the treatment of plaque PsO in 311 participants (icotrokinra=208; placebo=103) with at least moderate severity affecting special areas (e.g., scalp, genital and/or hands and feet) with overall IGA score of 0 or 1 with at least a 2-grade improvement as the primary endpoint. b.      The IGA is a five-point scale with a severity score ranging from 0 to 4, where 0 indicates clear, 1 is minimal, 2 is mild, 3 is moderate, and 4 indicates severe disease. 2 c.      The ss-IGA is a five-point scale where scalp lesions are assessed in terms of clinical signs of redness, thickness, and scaliness on a severity score ranging from 0 to 4, where 0 indicates absence of disease, 1 is very mild, 2 is mild, 3 is moderate and 4 indicates severe disease. d.      The sPGA-G is a six-point scale used to evaluate the severity of genital psoriasis at a given time point ranging from 0 to 5, where 0 indicates clear, 1 is minimal, 2 is mild, 3 is moderate, 4 is severe and 5 indicates very severe disease. 3 e.      The Physician’s Global Assessment of Psoriasis on the Hands and/or Feet (hf-PGA) assesses the severity of hand and foot psoriasis using a 5-point scale to score the plaques on the hands and feet as: clear (0), almost clear (1), mild (2), moderate (3) and severe (4). 4 f.       Dr. Melinda Gooderham is a paid consultant for Johnson & Johnson. She has not been compensated for any media work. About the ICONIC Clinical Development Program The pivotal Phase 3 ICONIC clinical development program of icotrokinra (JNJ-2113) in adult and adolescent individuals with moderate-to-severe plaque PsO was initiated with two studies in Q4 2023 – ICONIC-LEAD and ICONIC-TOTAL – pursuant to the license and collaboration agreement between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., a Johnson & Johson company. 5 ICONIC-LEAD ( NCT06095115 ) is a randomized controlled trial (RCT) to evaluate the efficacy and safety of icotrokinra compared with placebo in participants with moderate-to-severe plaque PsO, with PASI 90 and IGA score of 0 or 1 with at least a 2-grade improvement as co-primary endpoints. 6 ICONIC-TOTAL ( NCT06095102 ) is a RCT to evaluate the efficacy and safety of icotrokinra compared with placebo for the treatment of PsO in participants with at least moderate severity affecting special areas (e.g., scalp, genital, and/or hands and feet) with overall IGA score of 0 or 1 with at least a 2-grade improvement as the primary endpoint. 7 Other Phase 3 studies in the development program include ICONIC-ADVANCE 1 ( NCT06143878 ) and ICONIC-ADVANCE 2 ( NCT06220604 ), which are evaluating the efficacy and safety of icotrokinra compared with both placebo and deucravacitinib in adults with moderate-to-severe plaque PsO. 8,9 ICONIC-ASCEND will evaluate the efficacy and safety of icotrokinra compared with placebo and ustekinumab in participants with moderate-to-severe plaque psoriasis. ICONIC-PsA 1 ( NCT06878404 ) and ICONIC-PsA 2 ( NCT06807424 ) will evaluate the efficacy and safety of icotrokinra compared to placebo in participants with active psoriatic arthritis. 10,11 About Plaque Psoriasis Plaque psoriasis (PsO) is a chronic immune-mediated disease resulting in overproduction of skin cells, which causes inflamed, scaly plaques that may be itchy or painful. 12 It is estimated that 8 million Americans and more than 125 million people worldwide live with the disease. 13 Nearly one-quarter of all people with plaque PsO have cases that are considered moderate to severe. 14 On Caucasian skin, plaques typically appear as raised, red patches covered with a silvery white buildup of dead skin cells or scale. 14 On skin of color, the plaques may appear darker and thicker and more of a purple, gray or dark brown color. 15 Plaques can appear anywhere on the body, although they most often appear on the scalp, knees, elbows, and torso. 15 Living with plaque PsO can be a challenge and impact life beyond a person’s physical health, including emotional health, relationships, and handling the stressors of life. 15 Psoriasis on highly visible areas of the body or sensitive skin, such as the scalp, hands, feet, and genitals, can have an increased negative impact on quality of life. 15,16 About Icotrokinra (JNJ-77242113, JNJ-2113) Investigational icotrokinra is the first targeted oral peptide designed to selectively block the IL-23 receptor, 17 which underpins the inflammatory response in moderate-to-severe plaque PsO, ulcerative colitis and offers potential in other IL-23-mediated diseases. 18,19 Icotrokinra binds to the IL-23 receptor with single-digit picomolar affinity and demonstrated potent, selective inhibition of IL-23 signaling in human T cells. 20 The license and collaboration agreement established between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., a Johnson & Johnson company, in 2017 enabled the companies to work together to discover and develop next-generation compounds that ultimately led to icotrokinra. 21 Icotrokinra was jointly discovered and is being developed pursuant to the license and collaboration agreement between Protagonist and Johnson & Johnson. Johnson & Johnson retains exclusive worldwide rights to develop icotrokinra in Phase 2 clinical trials and beyond, and to commercialize compounds derived from the research conducted pursuant to the agreement against a broad range of indications. 22,23,24 Icotrokinra is being studied in the pivotal Phase 3 ICONIC clinical development program in moderate-to-severe plaque psoriasis and active psoriatic arthritis and the Phase 2b ANTHEM-UC study in moderately to severely active ulcerative colitis. About Johnson & Johnson At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com/ or at www.innovativemedicine.jnj.com . Follow us at @JNJInnovMed. Janssen Research & Development, LLC and Janssen Biotech, Inc. are Johnson & Johnson companies. 1 Gooderham, M.J. et al. Phase 3 results from an innovative trial design of treating plaque psoriasis involving difficult-to-treat, high-impact sites with icotrokinra, a targeted oral peptide that selectively inhibits the IL-23–receptor. Presented at the 2025 Society for Investigative Dermatology (Abstract #LB1142). May 2025. 2 Simpson E, Bissonnette R, Eichenfield LF, et al. The validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD™): The development and reliability testing of a novel clinical outcome measurement instrument for the severity of atopic dermatitis [published online April 25, 2020]. J Am Acad Dermatol. doi: 10.1016/j.jaad.2020.04.104. Accessed April 2025. 3 Merola JF, Bleakman AP, Gottlieb AB, et al. The Static Physician’s Global Assessment of Genitalia: a clinical outcome measure for the severity of genital psoriasis. J Drugs Dermatol. 2017;16(8):793-799 4 Goldblum O, et al. Validation of the physician’s global assessment of psoriasis of the hands and/or feet as a clinical endpoint. J Am Acad Dermatol. 2013:68(4)Supplement1:AB218. 5 Protagonist Therapeutics. Press release. Protagonist announces advancement of JNJ-2113 across multiple indications. Available at: https://www.accesswire.com/791174/protagonist-announces-advancement-of-jnj-2113-across-multiple-indications. Accessed May 2025. 6 Clinicaltrials.gov. A study of JNJ-2113 in adolescent and adult participants with moderate-to-severe plaque psoriasis (ICONIC-LEAD). Identifier NCT06095115. https://classic.clinicaltrials.gov/ct2/show/NCT06095115. Accessed May 2025. 7 Clinicaltrials.gov. A study of JNJ-2113 for the treatment of participants with plaque psoriasis involving special areas (scalp, genital, and/or palms of the hands and the soles of the feet) (ICONIC-TOTAL). Identifier NCT06095102. https://classic.clinicaltrials.gov/ct2/show/NCT06095102. Accessed May 2025. 8 Clinicaltrials.gov. A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis. Identifier NCT06143878. https://clinicaltrials.gov/study/NCT06143878?term=jnj-77242113&rank=10. Accessed May 2025. 9 Clinicaltrials.gov. A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2). Identifier NCT06220604. https://clinicaltrials.gov/study/NCT06220604. Accessed May 2025. 10 Clinicaltrials.gov. A Study to Evaluate the Efficacy and Safety of JNJ-77242113 (Icotrokinra) in Biologic-naïve Participants With Active Psoriatic Arthritis (ICONIC-PsA 1). Identifier NCT06878404. https://clinicaltrials.gov/study/NCT06878404 11 A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced Participants With Active Psoriatic Arthritis (ICONIC-PsA 2). Identifier NCT06807424. https://clinicaltrials.gov/study/NCT06807424 12 National Psoriasis Foundation. About Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis. Accessed May 2025. 13 National Psoriasis Foundation. Psoriasis Statistics. Available at: https://www.psoriasis.org/content/statistics. Accessed May 2025. 14 National Psoriasis Foundation. Plaque Psoriasis. Available at: https://www.psoriasis.org/plaque/.Accessed May 2025. 15 National Psoriasis Foundation. Life with Psoriasis. Available at: https://www.psoriasis.org/life-with-psoriasis/. Accessed May 2025. 16 National Psoriasis Foundation. High Impact Sites. Available at: https://www.psoriasis.org/high-impact-sites/. Accessed May 2025. 17 Bissonnette R, et al. Data presentation. A phase 2, randomized, placebo-controlled, dose-ranging study of oral JNJ-77242113 for the treatment of moderate-to-severe plaque psoriasis: FRONTIER 1. Presented at WCD 2023, July 3-8. 18 Razawy W, et al. The role of IL‐23 receptor signaling in inflammation‐mediated erosive autoimmune arthritis and bone remodeling. Eur J Immunol. 2018 Feb; 48(2): 220–229. 19 Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124. 20 Pinter A, et al. Data Presentation. JNJ-77242113 Treatment Induces a Strong Systemic Pharmacodynamic Response Versus Placebo in Serum Samples of Patients with Plaque Psoriasis: Results from the Phase 2, FRONTIER 1 Study. Presented at EADV 2023, October 11-14. 21 Johnson & Johnson. Press release. Janssen enters into worldwide exclusive license and collaboration agreement with Protagonist Therapeutics, Inc. for the oral Interlukin-23 receptor antagonist drug candidate for the treatment of Inflammatory Bowel Disease. Available at: https://www.jnj.com/media-center/press-releases/janssen-enters-into-worldwide-exclusive-license-and-collaboration-agreement-with-protagonist-therapeutics-inc-for-the-oral-interlukin-23-receptor-antagonist-drug-candidate-for-the-treatment-of-inflammatory-bowel-disease. Accessed May 2025. 22 Protagonist Therapeutics. Press release. Protagonist Therapeutics announces amendment of agreement with Janssen Biotech for the continued development and commercialization of IL-23 antagonists. Available at: https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-amendment-of-agreement-with-janssen-biotech-for-the-continued-development-and-commercialization-of-il-23-antagonists-301343621.html. Accessed May 2025. 23 Protagonist Therapeutics. Press release. Protagonist Reports positive results from Phase 1 and pre-clinical studies of oral Interleukin-23 receptor antagonist JNJ-2113. Available at: https://www.prnewswire.com/news-releases/protagonist-reports-positive-results-from-phase-1-and-pre-clinical-studies-of-oral-interleukin-23-receptor-antagonist-jnj-2113-301823039.html. Accessed May 2025. 24 Protagonist Therapeutics. Press release. Protagonist Therapeutics announces positive topline results for Phase 2b FRONTIER 1 clinical trial of oral IL-23 receptor antagonist JNJ-2113 (PN-235) in psoriasis. Available at: https://www.prnewswire.com/news-releases/protagonist-therapeutics-announces-positive-topline-results-for-phase-2b-frontier-1-clinical-trial-of-oral-il-23-receptor-antagonist-jnj-2113-pn-235-in-psoriasis-301764181.html. Accessed May 2025 . SOURCE: Johnson & Johnson