Protagonist Announces New Icotrokinra Data in Ulcerative Colitis and Plaque Psoriasis Presented at Two Recent Medical Conferences
Protagonist (NASDAQ:PTGX) reported updated clinical data for icotrokinra presented October 2025 showing sustained benefit across ulcerative colitis and plaque psoriasis studies. In Phase 2b ANTHEM-UC, icotrokinra 400 mg QD produced 31.7% clinical remission and 38.1% endoscopic improvement at Week 28 versus placebo 9.5% and 11.1%, respectively. Results support Phase 3 ICONIC-UC and Phase 2b/3 ICONIC-CD protocols initiated by Johnson & Johnson. In Phase 3 ICONIC-TOTAL, site-specific psoriasis clearance was high and durable: 72% scalp ss-IGA 0/1, 85% genital sPGA-G 0/1, and overall 67% IGA 0/1 maintained through Week 52, with similar safety profiles through Week 52 versus Week 16.
Protagonist (NASDAQ:PTGX) ha riportato dati clinici aggiornati per icotrokinra presentati ottobre 2025, mostrando beneficio sostenuto nei studi su colite ulcerosa e psoriasi a placche. Nella fase 2b ANTHEM-UC, icotrokinra 400 mg QD ha prodotto 31.7% remissione clinica e 38.1% miglioramento endoscopico a Settimana 28 rispetto al placebo 9.5% e 11.1%, rispettivamente. I risultati supportano i protocolli di Fase 3 ICONIC-UC e di Fase 2b/3 ICONIC-CD avviati da Johnson & Johnson. Nella Fase 3 ICONIC-TOTAL, la clearance della psoriasi specifica del sito è stata alta e duratura: 72% scalp ss-IGA 0/1, 85% genital sPGA-G 0/1, e complessivamente 67% IGA 0/1 mantenuti fino a Settimana 52, con profili di sicurezza simili fino a Settimana 52 rispetto a Settimana 16.
Protagonist (NASDAQ:PTGX) informó datos clínicos actualizados para icotrokinra presentados en octubre de 2025, mostrando beneficio sostenido en los estudios de colitis ulcerosa y psoriasis en placas. En la fase 2b ANTHEM-UC, icotrokinra 400 mg QD produjo 31.7% remisión clínica y 38.1% mejoría endoscópica en la Semana 28 frente a placebo 9.5% y 11.1%, respectivamente. Los resultados respaldan los protocolos de Fase 3 ICONIC-UC y Fase 2b/3 ICONIC-CD iniciados por Johnson & Johnson. En la Fase 3 ICONIC-TOTAL, la aclaramiento de la psoriasis específico del sitio fue alto y duradero: 72% scalp ss-IGA 0/1, 85% genital sPGA-G 0/1, y en conjunto 67% IGA 0/1 se mantuvo hasta la Semana 52, con perfiles de seguridad similares hasta la Semana 52 frente a la Semana 16.
프로타고니스트 (NASDAQ:PTGX)가 icotrokinra에 대한 업데이트된 임상 데이터를 2025년 10월 발표했으며 궤양성 대장염 및 플라크성 건선 연구에서 지속적인 이점을 보였습니다. 2b 단계 ANTHEM-UC에서 icotrokinra 400 mg QD는 주 28에 임상 관해 31.7% 및 내시경적 개선 38.1%를 기록했고, 위약은 각각 9.5% 및 11.1%였습니다. 결과는 Johnson & Johnson이 시작한 3상 ICONIC-UC 및 2b/3 ICONIC-CD 프로토콜을 지지합니다. 3상 ICONIC-TOTAL에서 부위별 건선 제거가 높고 지속적이었습니다: 72% 두피 ss-IGA 0/1, 85% 생식기 sPGA-G 0/1, 그리고 전체적으로 67% IGA 0/1가 52주까지 유지되었으며 16주 대비 52주에서도 안전성 프로파일이 유사했습니다.
Protagonist (NASDAQ:PTGX) a rapporté des données cliniques mises à jour pour icotrokinra présentées en octobre 2025, montrant un bénéfice soutenu dans les études sur la colite ulcéreuse et le psoriasis en plaques. Dans la phase 2b ANTHEM-UC, icotrokinra 400 mg/j a produit 31,7% de rémission clinique et 38,1% d'amélioration endoscopique à la semaine 28 par rapport au placebo 9,5% et 11,1%, respectivement. Les résultats soutiennent les protocoles de phase 3 ICONIC-UC et de phase 2b/3 ICONIC-CD lancés par Johnson & Johnson. Dans la phase 3 ICONIC-TOTAL, l'élimination spécifique au site du psoriasis était élevée et durable : 72% scalp ss-IGA 0/1, 85% genital sPGA-G 0/1, et globalement 67% IGA 0/1 maintenus jusqu'à la semaine 52, avec des profils de sécurité similaires jusqu'à la semaine 52 par rapport à la semaine 16.
Protagonist (NASDAQ:PTGX) meldete aktualisierte klinische Daten für icotrokinra, die im Oktober 2025 vorgestellt wurden, und zeigten einen anhaltenden Nutzen in Studien zu Colitis ulcerosa und Plaque-Psoriasis. In der Phase-2b ANTHEM-UC führte icotrokinra 400 mg QD zu 31,7% klinischer Remission und 38,1% endoskopischer Verbesserung in Woche 28 gegenüber Placebo 9,5% bzw. 11,1%. Die Ergebnisse unterstützen die Protokolle der Phase-3 ICONIC-UC und der Phase-2b/3 ICONIC-CD, initiiert von Johnson & Johnson. In Phase 3 ICONIC-TOTAL war die ksite-spezifische Psoriasis-Beseitigung hoch und dauerhaft: 72% scalp ss-IGA 0/1, 85% genital sPGA-G 0/1, und insgesamt 67% IGA 0/1 wurden bis Woche 52 beibehalten, mit ähnlichen Sicherheitsprofilen bis Woche 52 gegenüber Woche 16.
Protagonist (NASDAQ:PTGX) أبلغ عن بياناتٍ سريرية محدثة لـ icotrokinra قدَّمت في أكتوبر 2025، تُظهر فائدة مستمرة عبر دراسات التهاب القولون التقرحي والصدفية اللويحية. في المرحلة 2b ANTHEM-UC، أدى icotrokinra 400 mg يوميًا إلى 31.7% استقرار سريري و38.1% تحسن تنظيرياً في الأسبوع 28 مقارنةً بالدواء الوهمي 9.5% و11.1% على التوالي. تدعم النتائج بروتوكولات المرحلة 3 ICONIC-UC والمرحلة 2b/3 ICONIC-CD التي بدأت من Johnson & Johnson. في المرحلة 3 ICONIC-TOTAL، كان إزالة الصدفية المرتبطة بالموقع عالية ودائمة: 72% فروة الرأس ss-IGA 0/1، 85% الأجهزة التناسلية sPGA-G 0/1، وبشكل عام 67% IGA 0/1 مُحافظ عليها حتى الأسبوع 52، مع ملفات أمان مشابهة حتى الأسبوع 52 مقارنةً بالأسبوع 16.
Protagonist（NASDAQ:PTGX）公布了 icotrokinra 的更新临床数据，于 2025 年 10 月披露，显示在溃疡性结肠炎和斑块型银屑病研究中取得持续收益。在 2b 期 ANTHEM-UC 中，icotrokinra 400 mg QD 在第 28 周达到 31.7% 临床缓解 和 38.1% 内镜改善，对比安慰剂分别为 9.5% 与 11.1%。结果支持 Johnson & Johnson 启动的 3 期 ICONIC-UC 和 2b/3 ICONIC-CD 协议。在 3 期 ICONIC-TOTAL 中，部位特异性的银屑病清除高且持久：头皮 ss-IGA 0/1 72%、生殖部位 sPGA-G 0/1 85%，总体 IGA 0/1 67% 持续至第 52 周，且与第 16 周相比，第52周的安全性特征相似。
- ANTHEM-UC clinical remission of 31.7% at Week 28
- ANTHEM-UC endoscopic improvement of 38.1% at Week 28
- ICONIC-TOTAL overall IGA 0/1 of 67% maintained to Week 52
- High site-specific clearance: 72% scalp and 85% genital IGA 0/1
- Johnson & Johnson initiated ICONIC-UC Phase 3 and ICONIC-CD Phase 2b/3 protocols
- None.
Insights
Icotrokinra shows durable clinical activity in UC and high clearance rates in difficult psoriasis sites, supporting late‑stage development.
All reported
Risks and dependencies include reproducibility across larger populations and durability beyond the reported windows; safety was described as unchanged through
Concrete near‑term items to watch are topline results from the planned Phase 3 ICONIC‑UC and Phase 2b/3 ICONIC‑CD programs and full safety tables over the course of the next 12–36 months; also monitor interim readouts and regulatory briefing timelines that will follow those trials.
Icotrokinra demonstrated clinically meaningful outcomes at Week 28 in the Phase 2b ANTHEM-UC study in ulcerative colitis, with
Updated ANTHEM-UC data support Phase 3 clinical development of icotrokinra in both moderately to severely active ulcerative colitis and Crohn's disease
In areas of high impact,
Further,
NEWARK, CALIFORNIA / ACCESS Newswire / October 27, 2025 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") today announced new data from two studies of icotrokinra, a first-in-class investigational targeted oral peptide that precisely blocks the IL-23 receptor, presented at two recent medical conferences.
Week 28 data from the Phase 2b ANTHEM-UC study of icotrokinra will be presented at the 2025 American College of Gastroenterology Annual Scientific Meeting (ACG), demonstrating sustained and clinically meaningful results, with all doses (100 mg, 200 mg and 400 mg) showing higher rates of clinical response a , clinical remission b , endoscopic improvement c and histologic-endoscopic mucosal improvement (HEMI) d at Week 28 compared to placebo. [1] These outcomes build on Week 12 data that was recently presented at United European Gastroenterology (UEG) Week 2025.
Icotrokinra 400 mg once daily | Week 12 | Week 28 | Placebo (at Week 28) |
Clinical response 1 | |||
Clinical remission 1 | |||
Endoscopic improvement 1 | |||
HEMI rates 1 |
Based on results from the Phase 2b ANTHEM-UC study, Johnson & Johnson has initiated the ICONIC-UC Phase 3 protocol in adults and adolescents with moderately to severely active UC, as well as the ICONIC-CD Phase 2b/3 protocol in adults with moderate to severely active Crohn's disease.
Additionally, new long-term 52-week data from the Phase 3 ICONIC-TOTAL study e , presented last week at the 2025 Fall Clinical Dermatology Conference, show icotrokinra demonstrated high and durable rates of site-specific psoriasis clearance affecting these high-impact and difficult-to-treat areas of the body. [2]
72% of patients with scalp psoriasis achieved a scalp-specific Investigator's Global Assessment (ss-IGA) 0/1 score and57% achieved ss-IGA 0 f85% of patients with genital psoriasis achieved a Physician's Global Assessment of Genitalia (sPGA-G) 0/1 and73% achieved sPGA-G 0 g
In the smaller subset of patients with hand/foot psoriasis, treatment with icotrokinra showed a numerically higher rate of skin clearance at Week 16, which increased through Week 52 with patients achieving a hand and/or foot Physician's Global Assessment (hf-PGA) h score of 0/1 increasing from
Overall response rates among patients treated with once-daily icotrokinra were maintained through Week 52, with
"Additional data from Phase 2b ANTHEM-UC and Phase 3 ICONIC-TOTAL studies continue to show a strong durability of response and clinical benefit of icotrokinra treatment in a range of inflammatory and immunological diseases," said Dinesh V. Patel, Ph.D., President and Chief Executive Officer at Protagonist. "We are very pleased to see that the ICONIC development program now includes both ICONIC-UC, a Phase 3 study in adults with moderately to severely active UC, and ICONIC-CD, a Phase 2b/3 study in adults with moderate to severely active Crohn's disease. Our goal continues to be delivering well-differentiated oral targeted therapy treatments for patients as we continue to advance our oral peptides-based scientific and innovation leadership in the I&I field."
Editor's notes:
Clinical response was defined as a 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.
Clinical remission was defined as a stool frequency subscore of 0 or 1, a rectal bleeding subscore of 0, and an endoscopy subscore of 0 or 1.
Endoscopic improvement was defined as an endoscopy subscore of 0 or 1.
Histologic-endoscopic mucosal improvement (HEMI) was defined as histologic remission (absence of neutrophils from the mucosa in both lamina propria and epithelium, no crypt destruction, and no erosions, ulcerations, or granulation tissue according to the Geboes grading system) and endoscopic improvement (MES of 0 or 1).
ICONIC-TOTAL evaluates the efficacy and safety of icotrokinra compared with placebo in participants with at least moderate scalp, genital, and/or hand/foot PsO with once-daily icotrokinra or placebo, with placebo-to-icotrokinra transition at Week 16.
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.
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]
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]
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. [5]
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. Participants who complete the Week 28 assessments and have achieved clinical response at Week 28 and who, in the opinion of the investigator, will continue to benefit from treatment with study intervention will continue in the 48-week long term extension (LTE) period and receive the same treatment up to Week 76.
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.
About the ICONIC Clinical Development Program
The pivotal Phase 3 ICONIC clinical development program of icotrokinra (JNJ-2113) in adult and pediatric patients 12 years of age and older 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 & Johnson company.
ICONIC-LEAD ( NCT06095115 ) is a 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.
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.
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. 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.
Johnson & Johnson has also initiated the ICONIC-UC Phase 3 protocol in adults and adolescents with moderately to severely active UC as well as the ICONIC-CD Phase 2b/3 protocol in adults with moderate to severely active Crohn's disease.
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. It is estimated that 8 million Americans and more than 125 million people worldwide live with the disease. Nearly one-quarter of all people with plaque PsO have cases that are considered moderate-to-severe.Plaques typically appear as raised patches with a silvery white buildup of dead skin cells or scales.Plaques may appear red in lighter skin or more of a purple, gray or dark brown color in patients with darker skin tones. Plaques can appear anywhere on the body, although they most often appear on the scalp, knees, elbows, and torso.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. 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.
About Protagonist
Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. Two novel peptides derived from Protagonist's proprietary discovery platform are currently in advanced Phase 3 clinical development, with New Drug Application (NDA) for icotrokinra submitted to the FDA in July and in the NDA submission for rusfertide expected by end of 2025. Icotrokinra (formerly, JNJ-2113), is a first-in-class investigational targeted oral peptide that precisely blocks the Interleukin-23 receptor ("IL-23R") which is licensed to Janssen Biotech, Inc., a Johnson & Johnson company. Following icotrokinra's joint discovery by Protagonist and Johnson & Johnson scientists pursuant to the companies' IL-23R collaboration, Protagonist was primarily responsible for the development of icotrokinra through Phase 1, with Johnson & Johnson assuming responsibility for development in Phase 2 and beyond. Rusfertide, a mimetic of the natural hormone hepcidin, is currently in Phase 3 development for the rare blood disorder polycythemia vera (PV). Rusfertide is being co-developed and will be co-commercialized with Takeda Pharmaceuticals pursuant to a worldwide collaboration and license agreement entered in 2024 under which the Company remains primarily responsible for development through NDA filing. The Company also has a number of preclinical stage drug discovery programs addressing clinically and commercially validated targets, including IL-17 oral peptide antagonist PN-881, obesity triple agonist peptide PN-477, and the oral hepcidin program.
More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at https://www.protagonist-inc.com/ .
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements for purposes of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements regarding the potential benefits of icotrokinra, and expectations regarding the icotrokinra development program. In some cases, you can identify these statements by forward-looking words such as "anticipate," "believe," "may," "will," "expect," or the negative or plural of these words or similar expressions. Forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, our ability to develop and commercialize our product candidates, our ability to earn milestone payments under our collaboration agreements with Johnson & Johnson and Takeda, our ability to use and expand our programs to build a pipeline of product candidates, our ability to obtain and maintain regulatory approval of our product candidates, our ability to operate in a competitive industry and compete successfully against competitors that have greater resources than we do, and our ability to obtain and adequately protect intellectual property rights for our product candidates. Additional information concerning these and other risk factors affecting our business can be found in our periodic filings with the Securities and Exchange Commission, including under the heading "Risk Factors" contained in our most recently filed periodic reports on Form 10-K and Form 10-Q filed with the Securities and Exchange Commission. Forward-looking statements are not guarantees of future performance, and our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate, may differ materially from the forward-looking statements contained in this press release. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements, whether as a result of new information, future events or otherwise, after the date of this press release.
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References:
[1] Jairath V., et al. Efficacy and Safety of Icotrokinra, a Targeted Oral Peptide That Selectively Blocks IL-23 Receptor Activation, In Ulcerative Colitis: Results From Week 28 of ANTHEM-UC, a Phase 2b Dose-ranging Trial. Poster 1066 at ACG Annual Scientific Meeting 2025. October 2025.
[2] Lain, E et al. Durability of Response to the Targeted Oral Peptide Icotrokinra for High-Impact Site Psoriasis: 1-Year ICONIC-TOTAL Findings. Oral presentation (Presentation FC01.1G) at the 2025 Fall Clinical Dermatology Conference. October 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] 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.
SOURCE: Protagonist Therapeutics
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FAQ
What were the Week 28 ANTHEM-UC results for PTGX icotrokinra?
How do PTGX ICONIC-TOTAL psoriasis results perform at Week 52?
Did PTGX report safety issues with icotrokinra through Week 52?
What regulatory/clinical program moves followed PTGX ANTHEM-UC data?
What site-specific psoriasis improvements did PTGX report for icotrokinra?
