Icotrokinra meets primary endpoint of clinical response in ulcerative colitis study and shows potential to transform the treatment paradigm for patients
Johnson & Johnson (JNJ) announced positive topline results from the Phase 2b ANTHEM-UC study of icotrokinra (JNJ-2113), the first investigational targeted oral peptide that selectively blocks the IL-23 receptor, in adults with moderately to severely active ulcerative colitis.
The study met its primary endpoint with a clinical response rate of 63.5% for patients treated with the highest dose at Week 12 versus 27% for placebo. Additionally, 30.2% of patients achieved clinical remission at Week 12 compared to 11.1% in the placebo group. Both response and remission rates continued to improve through Week 28.
The trial involved 252 participants, testing three doses of once-daily icotrokinra. The drug demonstrated a favorable safety profile, with adverse events rates similar between treatment and placebo groups.
Johnson & Johnson (JNJ) ha annunciato risultati positivi preliminari dallo studio di Fase 2b ANTHEM-UC su icotrokinra (JNJ-2113), il primo peptide orale mirato in fase di sperimentazione che blocca selettivamente il recettore IL-23, in adulti con colite ulcerosa moderatamente a gravemente attiva.
Lo studio ha raggiunto il suo obiettivo primario con un tasso di risposta clinica del 63,5% per i pazienti trattati con la dose più alta alla Settimana 12 rispetto al 27% del gruppo placebo. Inoltre, il 30,2% dei pazienti ha raggiunto la remissione clinica alla Settimana 12 rispetto all'11,1% nel gruppo placebo. Sia i tassi di risposta che quelli di remissione hanno continuato a migliorare fino alla Settimana 28.
Lo studio ha coinvolto 252 partecipanti, testando tre dosi di icotrokinra assunta una volta al giorno. Il farmaco ha dimostrato un profilo di sicurezza favorevole, con tassi di eventi avversi simili tra i gruppi di trattamento e placebo.
Johnson & Johnson (JNJ) anunció resultados positivos preliminares del estudio de Fase 2b ANTHEM-UC sobre icotrokinra (JNJ-2113), el primer péptido oral dirigido en investigación que bloquea selectivamente el receptor IL-23, en adultos con colitis ulcerosa de moderada a grave actividad.
El estudio cumplió su objetivo primario con una tasa de respuesta clínica del 63.5% para los pacientes tratados con la dosis más alta a la Semana 12, en comparación con el 27% del grupo placebo. Además, el 30.2% de los pacientes logró la remisión clínica a la Semana 12 en comparación con el 11.1% en el grupo placebo. Tanto las tasas de respuesta como las de remisión continuaron mejorando hasta la Semana 28.
El ensayo involucró a 252 participantes, probando tres dosis de icotrokinra administrada una vez al día. El fármaco mostró un perfil de seguridad favorable, con tasas de eventos adversos similares entre los grupos de tratamiento y placebo.
존슨앤존슨 (JNJ)은 이코트로킨라 (JNJ-2113)에 대한 2b상 ANTHEM-UC 연구에서 긍정적인 초기 결과를 발표했습니다. 이 약물은 IL-23 수용체를 선택적으로 차단하는 첫 번째 연구 중인 경구용 펩타이드로, 중등도에서 중증의 활동성 궤양성 대장염 환자에게 사용됩니다.
이 연구는 12주 차에 가장 높은 용량으로 치료받은 환자들에서 임상 반응률 63.5%를 기록하며 주요 목표를 달성했으며, 위약 그룹은 27%였습니다. 또한, 30.2%의 환자가 위약 그룹의 11.1%와 비교하여 12주 차에 임상적 관해를 달성했습니다. 반응 및 관해 비율은 28주 차까지 계속 개선되었습니다.
이 시험에는 252명이 참여했으며, 하루 한 번 이코트로킨라의 세 가지 용량을 시험했습니다. 이 약물은 치료 그룹과 위약 그룹 간의 부작용 발생률이 유사하여 우호적인 안전성 프로필을 보여주었습니다.
Johnson & Johnson (JNJ) a annoncé des résultats préliminaires positifs de l'étude de phase 2b ANTHEM-UC sur icotrokinra (JNJ-2113), le premier peptide oral ciblé en cours d'investigation qui bloque sélectivement le récepteur IL-23, chez des adultes atteints de colite ulcéreuse modérément à sévèrement active.
L'étude a atteint son objectif principal avec un taux de réponse clinique de 63,5% pour les patients traités avec la dose la plus élevée à la semaine 12, contre 27% pour le groupe placebo. De plus, 30,2% des patients ont atteint une rémission clinique à la semaine 12 contre 11,1% dans le groupe placebo. Les taux de réponse et de rémission ont continué à s'améliorer jusqu'à la semaine 28.
L'essai a impliqué 252 participants, testant trois doses d'icotrokinra administrées une fois par jour. Le médicament a montré un profil de sécurité favorable, avec des taux d'événements indésirables similaires entre les groupes de traitement et de placebo.
Johnson & Johnson (JNJ) gab positive vorläufige Ergebnisse aus der Phase 2b-Studie ANTHEM-UC zu icotrokinra (JNJ-2113), dem ersten experimentellen gezielten oralen Peptid, das selektiv den IL-23-Rezeptor blockiert, bei Erwachsenen mit mäßig bis schwer aktiver Colitis ulcerosa bekannt.
Die Studie erreichte ihr primäres Ziel mit einer klinischen Ansprechrate von 63,5% für Patienten, die die höchste Dosis in der Woche 12 erhielten, im Vergleich zu 27% in der Placebogruppe. Darüber hinaus erreichten 30,2% der Patienten in der Woche 12 eine klinische Remission im Vergleich zu 11,1% in der Placebogruppe. Sowohl die Ansprech- als auch die Remissionsraten verbesserten sich bis zur Woche 28 weiter.
Die Studie umfasste 252 Teilnehmer und testete drei Dosen von einmal täglich verabreichtem icotrokinra. Das Medikament zeigte ein günstiges Sicherheitsprofil, mit ähnlichen Raten unerwünschter Ereignisse zwischen den Behandlungs- und Placebogruppen.
- Phase 2b trial met primary endpoint with 63.5% clinical response rate vs 27% placebo
- Achieved 30.2% clinical remission rate vs 11.1% placebo at Week 12
- Response and remission rates continued improving through Week 28
- Favorable safety profile demonstrated with adverse events similar to placebo
- Once-daily oral administration offers convenient dosing
- None.
Insights
Johnson & Johnson's announcement of positive Phase 2b results for icotrokinra in ulcerative colitis represents a significant clinical milestone with substantial commercial implications. The data is particularly impressive with
The results are compelling for three key reasons: First, icotrokinra's oral administration addresses a critical unmet need in the inflammatory bowel disease space, where current IL-23 inhibitors require injection. Patient preference for oral therapies could drive substantial market adoption if approved. Second, the continued improvement through Week 28 suggests durable efficacy, essential for chronic conditions like UC. Third, the favorable safety profile with adverse events comparable to placebo is important for long-term therapy.
The multi-indication potential across immune-mediated diseases strengthens icotrokinra's commercial prospects, building on J&J's positive psoriasis data. J&J's extensive experience in immunology and the IL-23 pathway (with Tremfya/guselkumab) provides strategic advantage for development and commercialization. While Phase 3 studies and regulatory approvals remain ahead, these robust results position icotrokinra as a potential transformative therapy that could significantly strengthen J&J's immunology franchise.
The ANTHEM-UC trial results for icotrokinra represent a potential paradigm shift in ulcerative colitis management. The
From a clinical perspective, the selective IL-23 receptor blockade mechanism is particularly promising as it targets a specific inflammatory pathway implicated in UC pathogenesis. This targeted approach, combined with oral administration, could offer significant advantages over current treatment options. The standard UC treatment paradigm currently progresses from conventional therapies to biologics (often injectable) with broader immunosuppressive effects.
The safety profile is encouraging, with adverse event rates similar to placebo – critical for chronic conditions requiring long-term management. For gastroenterologists, an oral agent with this efficacy profile and favorable safety would fill a substantial gap between conventional therapies and biologics. Patient adherence, a persistent challenge in UC management, could also improve with oral administration.
The endpoints used (clinical response, clinical remission, symptomatic remission, and endoscopic improvement) are industry-standard, clinically meaningful measures that directly correlate with patient outcomes and quality of life. While Phase 3 data will be essential for definitive evaluation, these results suggest icotrokinra could become a valuable addition to the UC treatment armamentarium.
Topline results also show investigational targeted oral peptide icotrokinra achieved clinical remission rates up to
Clinical response and remission rates continued to improve through Week 28, building on strong data recently reported for the plaque psoriasis Phase 3 program
Icotrokinra demonstrates potential to offer therapeutic benefit and tolerability with a once daily oral treatment
In the ANTHEM-UC study (n=252), three doses of once daily icotrokinra were tested with all meeting the primary endpoint of clinical response at Week 12. A response rate of
Icotrokinra was well tolerated with proportions of participants reporting one or more adverse events (AEs) being similar between the icotrokinra dose groups and the placebo group.1
"These impressive findings show the potential of icotrokinra to transform the treatment paradigm for people living with ulcerative colitis by offering a distinctive combination of therapeutic benefit, tolerability, and convenience with a once-daily oral treatment," said Esi Lamousé-Smith, M.D., Ph.D., Vice President, Gastroenterology Disease Area Lead, Immunology, Johnson & Johnson. "With over a quarter century of innovation in inflammatory bowel disease, coupled with our deep expertise in the IL-23 pathway, we are excited about these results and the groundbreaking potential of icotrokinra in the treatment of immune-mediated diseases."
Comprehensive results from the ANTHEM-UC study are being prepared for presentation at upcoming medical congresses.
Editor's notes:
a. Clinical response is defined as decrease from baseline in the modified Mayo score by greater than or equal to (>=) 30 percent (%) and >=2 points, with either a >=1-point decrease from baseline in the rectal bleeding subscore or a rectal bleeding subscore of 0 or 1.
b. Clinical remission is defined as a Mayo stool frequency subscore of 0 or 1 and not increased from induction baseline, a Mayo rectal bleeding subscore of 0, and a Mayo endoscopy subscore of 0 or 1 with no friability present on the endoscopy.
About ANTHEM-UC
ANTHEM-UC (NCT06049017) is a Phase 2b multicenter, randomized, placebo-controlled, dose-ranging study to evaluate the efficacy and safety of icotrokinra (JNJ-77242113, JNJ-2113) in patients with moderately to severely active ulcerative colitis who had an inadequate response or intolerance to conventional therapy (e.g., thiopurines or corticosteroids), prior biologics (TNF antagonists or vedolizumab) and/or ozanimod or approved JAK inhibitors. The study is evaluating three once-daily dosages of icotrokinra taken orally.2
About Ulcerative Colitis
Ulcerative colitis (UC) is a chronic disease of the large intestine, also known as the colon, in which the lining of the colon becomes inflamed and develops tiny open sores, or ulcers, that produce pus and mucus. It is the result of the immune system's overactive response. Symptoms vary but may typically include loose and more urgent bowel movements, rectal bleeding or bloody stool, persistent diarrhea, abdominal pain, loss of appetite, weight loss, and fatigue.3
About Icotrokinra (JNJ-77242113, JNJ-2113)
Investigational icotrokinra is the first targeted oral peptide designed to selectively block the IL-23 receptor,4 which underpins the inflammatory response in moderate-to-severe plaque psoriasis, ulcerative colitis and offers potential in other IL-23-mediated diseases.5,6 Icotrokinra binds to the IL-23 receptor with single-digit picomolar affinity and demonstrated potent, selective inhibition of IL-23 signalling in human T cells.7 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.8 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.9,10,11
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.
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 most recent Annual Report on Form 10-K, 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.
1Data on file.
2Clinicaltrials.gov. A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis (ANTHEM-UC). Identifier NCT06049017. https://clinicaltrials.gov/study/NCT06049017?term=ANTHEM-UC&rank=1. Accessed February 2025.
3Crohn's & Colitis Foundation. What is ulcerative colitis? Available at: https://www.crohnscolitisfoundation.org/what-is-ulcerative-colitis. Accessed April 2024.
4Bissonnette 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.
5Razawy 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.
6Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124.
7Pinter 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.
8Johnson & 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.
9Protagonist 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.
10Protagonist 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.
11Protagonist 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.
Media contact:
Craig Stoltz
cstoltz@its.jnj.com
Investor contact:
Lauren Johnson
investor-relations@its.jnj.com
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SOURCE Johnson & Johnson
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