Icotrokinra delivered an industry-leading combination of significant skin clearance with demonstrated tolerability in a once daily pill in Phase 3 topline results
Johnson & Johnson (NYSE: JNJ) announced positive Phase 3 topline results for icotrokinra (JNJ-2113), a first-in-class oral peptide targeting IL-23 receptor for moderate to severe plaque psoriasis. The drug met its co-primary endpoints, with 64.7% of patients achieving clear/almost clear skin (IGA 0/1) and 49.6% achieving PASI 90 at week 16, compared to 8.3% and 4.4% on placebo. Results improved at week 24, with 74.1% achieving IGA 0/1 and 64.9% reaching PASI 90. Safety profile aligned with Phase 2 studies, showing similar adverse events between treatment and placebo groups.
Johnson & Johnson (NYSE: JNJ) ha annunciato risultati positivi della fase 3 per icotrokinra (JNJ-2113), un peptide orale innovativo che agisce sul recettore IL-23 per la psoriasi a placche da moderata a grave. Il farmaco ha raggiunto i suoi obiettivi primari, con il 64,7% dei pazienti che ha ottenuto una pelle chiara/quasi chiara (IGA 0/1) e il 49,6% che ha raggiunto un PASI 90 alla settimana 16, rispetto all'8,3% e al 4,4% nel gruppo placebo. I risultati sono migliorati alla settimana 24, con il 74,1% che ha raggiunto l'IGA 0/1 e il 64,9% che ha ottenuto un PASI 90. Il profilo di sicurezza è in linea con gli studi di fase 2, mostrando eventi avversi simili tra i gruppi di trattamento e placebo.
Johnson & Johnson (NYSE: JNJ) anunció resultados positivos de fase 3 para icotrokinra (JNJ-2113), un péptido oral de primera clase que se dirige al receptor IL-23 para la psoriasis en placas de moderada a grave. El fármaco cumplió con sus objetivos primarios, con un 64.7% de los pacientes logrando piel clara/casi clara (IGA 0/1) y un 49.6% alcanzando PASI 90 a la semana 16, en comparación con el 8.3% y el 4.4% en el grupo placebo. Los resultados mejoraron en la semana 24, con un 74.1% logrando IGA 0/1 y un 64.9% alcanzando PASI 90. El perfil de seguridad fue coherente con los estudios de fase 2, mostrando eventos adversos similares entre los grupos de tratamiento y placebo.
존슨앤존슨 (NYSE: JNJ)은 중증의 판상 건선 치료를 위한 IL-23 수용체를 겨냥한 첫 번째 경구 펩타이드인 이코트로킨라 (JNJ-2113)의 3상 긍정적인 최종 결과를 발표했습니다. 이 약물은 64.7%의 환자가 깨끗한/거의 깨끗한 피부 (IGA 0/1)를 달성하고 49.6%가 16주 차에 PASI 90에 도달했습니다. 이는 각각 위약군의 8.3% 및 4.4%에 비해 높은 수치입니다. 결과는 24주 차에 개선되어 74.1%가 IGA 0/1을 달성하고 64.9%가 PASI 90에 도달했습니다. 안전 프로필은 2상 임상 시험과 일치하여 치료 그룹과 위약 그룹 간의 부작용이 유사하게 나타났습니다.
Johnson & Johnson (NYSE: JNJ) a annoncé des résultats positifs de phase 3 pour icotrokinra (JNJ-2113), un peptide oral de première classe ciblant le récepteur IL-23 pour le psoriasis en plaques modéré à sévère. Le médicament a atteint ses objectifs primaires, avec 64,7% des patients atteignant une peau claire/ presque claire (IGA 0/1) et 49,6% atteignant un PASI 90 à la semaine 16, comparé à 8,3% et 4,4% dans le groupe placebo. Les résultats se sont améliorés à la semaine 24, avec 74,1% atteignant IGA 0/1 et 64,9% atteignant PASI 90. Le profil de sécurité était en ligne avec les études de phase 2, montrant des événements indésirables similaires entre les groupes de traitement et de placebo.
Johnson & Johnson (NYSE: JNJ) hat positive Ergebnisse der Phase 3 für icotrokinra (JNJ-2113) bekannt gegeben, ein erstes oral verabreichtes Peptid, das auf den IL-23-Rezeptor abzielt und für moderate bis schwere plaque Psoriasis eingesetzt wird. Das Medikament hat seine primären Endpunkte erreicht, wobei 64,7% der Patienten klare/fast klare Haut (IGA 0/1) erzielten und 49,6% bei Woche 16 PASI 90 erreichten, im Vergleich zu 8,3% und 4,4% unter Placebo. Die Ergebnisse verbesserten sich in Woche 24, mit 74,1% die IGA 0/1 erreichten und 64,9% PASI 90 erfuhren. Das Sicherheitsprofil stimmte mit den Phase-2-Studien überein und wies ähnliche unerwünschte Ereignisse zwischen den Behandlungs- und Placebogruppen auf.
- Met co-primary endpoints in Phase 3 ICONIC-LEAD trial
- 74.1% of patients achieved clear/almost clear skin at week 24
- 64.9% of patients achieved PASI 90 at week 24
- Safety profile consistent with Phase 2 studies
- Met primary endpoint in ICONIC-TOTAL study
- 49.3% of participants experienced treatment emergent adverse events
Insights
The Phase 3 trial results for icotrokinra represent a significant breakthrough in psoriasis treatment. The 74.1% IGA 0/1 response rate and 64.9% PASI 90 achievement at week 24 are remarkably strong efficacy metrics that position this drug competitively in the psoriasis market. The oral administration route provides a notable advantage over existing injectable biologics.
The safety profile appears favorable, with TEAEs comparable to placebo (
This development could reshape JNJ's position in the $26 billion global psoriasis market. The oral administration advantage could help capture market share from injectable biologics like Humira and Stelara. The comprehensive clinical program, including special areas treatment and psoriatic arthritis studies, suggests a broad commercial strategy.
The impressive efficacy data, combined with the convenience of oral administration, positions icotrokinra as a potential market leader. This could significantly impact JNJ's immunology portfolio, especially as biosimilar competition increases for their existing products. The inclusion of adolescent patients also opens additional market opportunities.
Icotrokinra (JNJ-2113), a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor, met its co-primary endpoints in patients with moderate to severe plaque psoriasis
Comprehensive results are being prepared for presentation at upcoming medical congresses
Once daily icotrokinra showed significant skin clearance versus placebo in adults and adolescents with moderate to severe plaque psoriasis. At week 16, nearly two-thirds (
Furthermore, positive topline results from the Phase 3 ICONIC-TOTALd study showed once daily icotrokinra met the primary endpoint of IGA of 0/1 at week 16 compared to placebo.4 Comprehensive results from ICONIC-LEAD and ICONIC-TOTAL are being prepared for presentation at upcoming medical congresses and will be shared with health authorities in planned submissions.
"We are excited to see impressive Phase 3 results with once-daily icotrokinra treatment aligned with our Phase 2 study of this first-in-class targeted oral peptide that selectively blocks the IL-23 receptor," said Liza O'Dowd, Vice President, Immunodermatology Disease Area Lead, Johnson & Johnson Innovative Medicine. "The majority of people living with moderate to severe plaque psoriasis are eligible for, but are still not receiving, advanced therapies. Icotrokinra has the potential to offer once-daily oral therapy that could help address the needs and preferences of people living with plaque psoriasis."
Other studies in the Phase 3 ICONIC clinical development program are ongoing, including ICONIC-ADVANCE 1 and ICONIC-ADVANCE 2, which will evaluate the safety and efficacy of icotrokinra compared with both placebo and deucravacitinib in moderate to severe plaque PsO. The Phase 3 ICONIC-PsA program which will investigate icotrokinra in psoriatic arthritis will be initiated in the beginning of 2025.
Editor's notes:
a. ICONIC-LEAD is a randomized controlled trial (RCT) to evaluate the safety and efficacy of icotrokinra compared with placebo in participants 12 years of age or older with moderate to severe plaque PsO, with the higher efficacy bar of PASI 90 and IGA score of 0/1 with at least a 2-grade improvement as co-primary endpoints. ICONIC-LEAD enrolled 66 adolescent patients.
b. The PASI score grades the amount of surface area on each body region that is covered by psoriasis plaques and the severity of plaques for their redness, thickness and scaliness.5 PASI 90 corresponds to an improvement of >=
c. The IGA is a five-point scale with a severity ranging from 0 to 4, where 0 indicates clear, 1 is minimal, 2 is mild, 3 is moderate, and 4 indicates severe disease.6
d. ICONIC-TOTAL 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.
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.7
ICONIC-LEAD (NCT06095115) is a randomized controlled trial (RCT) to evaluate the safety and efficacy 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.8
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.9
Other Phase 3 studies in the development program include ICONIC-ADVANCE 1 (NCT06143878) and ICONIC-ADVANCE 2 (NCT06220604), which evaluate the safety and efficacy of icotrokinra compared with both placebo and deucravacitinib in adults with moderate to severe plaque PsO.10
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.11 It is estimated that eight million Americans and more than 125 million people worldwide live with the disease.12 Nearly one-quarter of all people with plaque PsO have cases that are considered moderate to severe.12 On Caucasian skin, plaques typically appear as raised, red patches covered with a silvery white buildup of dead skin cells or scale.13 On skin of color, the plaques may appear darker and thicker and more of a purple, gray or dark brown color.13 Plaques can appear anywhere on the body, although they most often appear on the scalp, knees, elbows, and torso.13 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.14 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.13,15
About Icotrokinra (JNJ-77242113, JNJ-2113)
Investigational icotrokinra is the first targeted oral peptide designed to selectively block the IL-23 receptor,3 which underpins the inflammatory response in moderate to severe plaque PsO and other IL-23-mediated diseases.16,17 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.18 The license and collaboration agreement established between Protagonist Therapeutics, Inc. and Janssen Biotech, Inc., in 2017 enabled the companies to work together to discover and develop next-generation compounds that ultimately led to icotrokinra.19 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.20,21,22
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.
Cautions Concerning Forward-Looking Statements
This press release contains "forward-looking statements" as defined in the Private Securities Litigation Reform Act of 1995 regarding icotrokinra (JNJ-2113). The reader is cautioned not to rely on these forward-looking statements. These statements are based on current expectations of future events. If underlying assumptions prove inaccurate or known or unknown risks or uncertainties materialize, actual results could vary materially from the expectations and projections of Janssen Research & Development, LLC, Janssen Biotech, Inc. and/or Johnson & Johnson. Risks and uncertainties include, but are not limited to: challenges and uncertainties inherent in product research and development, including the uncertainty of clinical success and of obtaining regulatory approvals; uncertainty of commercial success; manufacturing difficulties and delays; competition, including technological advances, new products and patents attained by competitors; challenges to patents; product efficacy or safety concerns resulting in product recalls or regulatory action; changes in behavior and spending patterns of purchasers of health care products and services; changes to applicable laws and regulations, including global health care reforms; and trends toward health care cost containment. A further list and descriptions of these risks, uncertainties and other factors can be found in Johnson & Johnson's Annual Report on Form 10-K for the fiscal year ended December 31, 2023, including in the sections captioned "Cautionary Note Regarding Forward-Looking Statements" and "Item 1A. Risk Factors," and in Johnson & Johnson's subsequent Quarterly Reports on Form 10-Q and other filings with the Securities and Exchange Commission. Copies of these filings are available online at www.sec.gov, www.jnj.com or on request from Johnson & Johnson. None of Janssen Research & Development, LLC, Janssen Biotech, Inc. nor Johnson & Johnson undertakes to update any forward-looking statement as a result of new information or future events or developments.
1 Data on file.
2 Ferris, L et al. A Phase 2b, Long-term Extension, Dose-ranging Study of Oral JNJ-77242113 for the Treatment of Moderate to Severe Plaque Psoriasis: FRONTIER 2. Oral presentation (Abstract #S026) at the American Academy of Dermatology (AAD) 2024 Annual Meeting. March 2024.
3 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.
4 Data on file.
5 Thompson Jr, D. How the Psoriasis Area and Severity Index works. Everyday Health. Available at: https://www.everydayhealth.com/psoriasis/living-with/how-the-pasi-index-works. Accessed November 2024.
6 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 November 2024.
7 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 November 2024.
8 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 November 2024.
9 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 November 2024.
10 Protagonist Therapeutics. Press release. Protagonist announces two new phase 3 ICONIC studies in psoriasis evaluating JNJ-2113 in head-to-head comparisons with deucravacitinib. Available at: https://www.accesswire.com/810075/protagonist-announces-two-new-phase-3-iconic-studies-in-psoriasis-evaluating-jnj-2113-in-head-to-head-comparisons-with-deucravacitinib. Accessed November 2024.
11 National Psoriasis Foundation. About Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis. Accessed November 2024.
12 National Psoriasis Foundation. Psoriasis Statistics. Available at: https://www.psoriasis.org/content/statistics. Accessed November 2024.
13 National Psoriasis Foundation. Plaque Psoriasis. Available at: https://www.psoriasis.org/plaque/.Accessed November 2024.
14 National Psoriasis Foundation. Life with Psoriasis. Available at: https://www.psoriasis.org/life-with-psoriasis/. Accessed November 2024.
15 National Psoriasis Foundation. High Impact Sites. Available at: https://www.psoriasis.org/high-impact-sites/. Accessed Sep November 2024.
16 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.
17 Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124.
18 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.
19 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 November 2024.
20 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 November 2024.
21 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 November 2024.
22 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 November 2024.
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SOURCE Johnson & Johnson
FAQ
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