Icotrokinra Clinical Study Results Demonstrate Its Potential to Shift Treatment Paradigm and Set a New Standard for Treatment in Plaque Psoriasis
Protagonist Therapeutics announced breakthrough results for icotrokinra (JNJ-2113), a first-in-class oral peptide for moderate-to-severe plaque psoriasis (PsO). In the Phase 3 ICONIC-LEAD study, the once-daily pill demonstrated remarkable efficacy with 46% of patients achieving completely clear skin (IGA 0) at Week 24.
Key findings at Week 24 showed 74% of patients achieved clear/almost clear skin (IGA 0/1) and 65% reached PASI 90. The drug demonstrated a favorable safety profile, with adverse events comparable to placebo (49% in both groups).
Additionally, in the ICONIC-ADVANCE 1&2 studies, icotrokinra showed superiority to deucravacitinib, meeting all primary and secondary endpoints. Based on these positive results, a groundbreaking head-to-head study (ICONIC-ASCEND) will compare icotrokinra against injectable biologic ustekinumab, potentially establishing a new standard in PsO treatment.
Protagonist Therapeutics ha annunciato risultati straordinari per icotrokinra (JNJ-2113), un peptide orale di prima classe per la psoriasi a placche da moderata a grave (PsO). Nello studio di Fase 3 ICONIC-LEAD, la pillola assunta una volta al giorno ha dimostrato un'efficacia notevole, con il 46% dei pazienti che ha raggiunto una pelle completamente chiara (IGA 0) alla settimana 24.
I risultati chiave alla settimana 24 hanno mostrato che il 74% dei pazienti ha ottenuto una pelle chiara/quasi chiara (IGA 0/1) e il 65% ha raggiunto PASI 90. Il farmaco ha dimostrato un profilo di sicurezza favorevole, con eventi avversi comparabili al placebo (49% in entrambi i gruppi).
Inoltre, negli studi ICONIC-ADVANCE 1&2, icotrokinra ha mostrato superiorità rispetto a deucravacitinib, raggiungendo tutti gli obiettivi primari e secondari. Sulla base di questi risultati positivi, uno studio innovativo testa a testa (ICONIC-ASCEND) confronterà icotrokinra con il biologico iniettabile ustekinumab, potenzialmente stabilendo un nuovo standard nel trattamento della PsO.
Protagonist Therapeutics anunció resultados innovadores para icotrokinra (JNJ-2113), un péptido oral de primera clase para la psoriasis en placas de moderada a severa (PsO). En el estudio de Fase 3 ICONIC-LEAD, la pastilla que se toma una vez al día demostró una eficacia notable, con el 46% de los pacientes alcanzando una piel completamente clara (IGA 0) a la semana 24.
Los hallazgos clave a la semana 24 mostraron que el 74% de los pacientes logró una piel clara/casi clara (IGA 0/1) y el 65% alcanzó PASI 90. El medicamento mostró un perfil de seguridad favorable, con eventos adversos comparables al placebo (49% en ambos grupos).
Además, en los estudios ICONIC-ADVANCE 1&2, icotrokinra mostró superioridad frente a deucravacitinib, cumpliendo todos los objetivos primarios y secundarios. Basado en estos resultados positivos, se llevará a cabo un innovador estudio comparativo (ICONIC-ASCEND) que comparará icotrokinra con el biológico inyectable ustekinumab, estableciendo potencialmente un nuevo estándar en el tratamiento de la PsO.
Protagonist Therapeutics는 중등도에서 중증의 판상 건선(PsO)을 위한 최초의 경구 펩타이드인 icotrokinra (JNJ-2113)의 혁신적인 결과를 발표했습니다. 3상 ICONIC-LEAD 연구에서 하루에 한 번 복용하는 이 약은 환자의 46%가 완전히 깨끗한 피부를 달성 (IGA 0)하는 놀라운 효능을 보여주었습니다.
24주 차의 주요 결과는 환자의 74%가 깨끗한/거의 깨끗한 피부를 달성 (IGA 0/1)했으며, 65%가 PASI 90에 도달했음을 보여주었습니다. 이 약물은 안전성 프로필이 우수하며, 부작용은 위약과 유사했습니다 (두 그룹 모두 49%).
또한 ICONIC-ADVANCE 1&2 연구에서 icotrokinra는 deucravacitinib보다 우수성을 보였으며, 모든 주요 및 부차적 목표를 달성했습니다. 이러한 긍정적인 결과를 바탕으로 icotrokinra와 주사 생물학적 제제인 ustekinumab을 비교하는 혁신적인 대면 연구(ICONIC-ASCEND)가 진행될 예정이며, 이는 PsO 치료의 새로운 기준을 설정할 수 있습니다.
Protagonist Therapeutics a annoncé des résultats révolutionnaires pour icotrokinra (JNJ-2113), un peptide oral de première classe pour la psoriasis en plaques modéré à sévère (PsO). Dans l'étude de Phase 3 ICONIC-LEAD, le comprimé pris une fois par jour a montré une efficacité remarquable, avec 46% des patients atteignant une peau complètement claire (IGA 0) à la semaine 24.
Les résultats clés à la semaine 24 ont montré que 74% des patients ont obtenu une peau claire/ presque claire (IGA 0/1) et 65% ont atteint PASI 90. Le médicament a démontré un profil de sécurité favorable, avec des événements indésirables comparables à ceux du placebo (49% dans les deux groupes).
De plus, dans les études ICONIC-ADVANCE 1&2, icotrokinra a montré une supériorité par rapport à deucravacitinib, atteignant tous les objectifs primaires et secondaires. Sur la base de ces résultats positifs, une étude comparative innovante (ICONIC-ASCEND) comparera icotrokinra avec le biologique injectable ustekinumab, établissant potentiellement une nouvelle norme dans le traitement de la PsO.
Protagonist Therapeutics hat bahnbrechende Ergebnisse für icotrokinra (JNJ-2113) angekündigt, ein erstes orales Peptid für moderate bis schwere Plaque-Psoriasis (PsO). In der Phase-3-Studie ICONIC-LEAD zeigte die einmal täglich eingenommene Tablette bemerkenswerte Wirksamkeit, wobei 46% der Patienten eine vollständig klare Haut erreichten (IGA 0) in der Woche 24.
Die wichtigsten Ergebnisse in Woche 24 zeigten, dass 74% der Patienten klare/fast klare Haut erreichten (IGA 0/1) und 65% PASI 90 erreichten. Das Medikament zeigte ein günstiges Sicherheitsprofil, mit unerwünschten Ereignissen, die mit dem Placebo vergleichbar waren (49% in beiden Gruppen).
Darüber hinaus zeigte icotrokinra in den Studien ICONIC-ADVANCE 1&2 Überlegenheit gegenüber deucravacitinib und erfüllte alle primären und sekundären Endpunkte. Basierend auf diesen positiven Ergebnissen wird eine bahnbrechende Vergleichsstudie (ICONIC-ASCEND) durchgeführt, die icotrokinra mit dem injizierbaren Biologikum ustekinumab vergleicht und möglicherweise einen neuen Standard in der PsO-Behandlung festlegt.
- 46% of patients achieved completely clear skin at Week 24
- Superior efficacy compared to deucravacitinib in head-to-head trials
- Favorable safety profile equivalent to placebo (49% adverse events)
- Strong efficacy with 74% achieving clear/almost clear skin at Week 24
- First-in-class oral treatment showing potential superiority to injectable biologics
- 51% of patients still did not achieve completely clear skin
- Long-term safety data beyond 24 weeks not yet available
Insights
Protagonist's icotrokinra clinical trial data represents a significant breakthrough in psoriasis treatment, potentially establishing a new standard of care. The Phase 3 ICONIC-LEAD results showing 46% of patients achieving completely clear skin (IGA 0) and 40% reaching PASI 100 at Week 24 are remarkably strong efficacy signals that exceed typical outcomes for oral psoriasis therapies.
What's particularly compelling is icotrokinra's differentiated mechanism as the first-in-class oral IL-23 receptor antagonist. This targeted approach has previously been available only in injectable biologics, with oral options typically showing lower efficacy. The favorable safety profile (49% AEs, comparable to placebo) suggests a potential best-in-class treatment option.
The superiority demonstrated over deucravacitinib in the ICONIC-ADVANCE studies further validates icotrokinra's exceptional efficacy profile. This positions Protagonist and partner Johnson & Johnson to potentially capture significant market share in the
The initiation of the ICONIC-ASCEND trial comparing icotrokinra to ustekinumab represents a bold but data-supported strategy to demonstrate superiority over injectable biologics. If successful, this would fundamentally reshape treatment protocols, positioning oral therapy as first-line treatment before biologics—a paradigm shift with substantial commercial implications for Protagonist's revenue potential.
The clinical results for icotrokinra represent a major value inflection point for Protagonist Therapeutics. The robust efficacy data across multiple Phase 3 trials substantially de-risks the company's lead asset and enhances probability of regulatory approval.
Protagonist's partnership with Johnson & Johnson provides critical validation and commercialization muscle. The superior efficacy demonstrated against deucravacitinib is particularly noteworthy as it differentiates icotrokinra in an increasingly competitive market landscape.
The psoriasis market represents a massive commercial opportunity with high-efficacy oral treatments commanding premium pricing. If approved, icotrokinra would occupy a unique position as potentially the most effective oral therapy, addressing the significant unmet need between conventional systemics and biologics.
The planned head-to-head trial against ustekinumab is a strategic masterstroke that could significantly expand the drug's market potential. A favorable outcome would position icotrokinra to capture substantial market share from both existing oral treatments and injectable biologics, translating to blockbuster revenue potential.
With these compelling Phase 3 results, Protagonist has substantially strengthened its competitive position. The company is now poised to potentially transform treatment pathways in psoriasis while capturing significant value from this major advancement in their pipeline.
Nearly half of patients with moderate-to-severe plaque psoriasis (PsO) treated with icotrokinra achieved completely clear skin (IGA 0) at Week 24 in Phase 3 ICONIC-LEAD study
Topline results from Phase 3 ICONIC-ADVANCE 1&2studies show icotrokinra achieved co-primary endpoints and showed superiority to deucravacitinib in moderate-to-severe PsO
Results pave the way to initiate the first-ever head-to-head study (ICONIC-ASCEND) seeking to demonstrate the superiority of a pill versus injectable biologic in moderate-to-severe PsO
NEWARK, CA / ACCESS Newswire / March 8, 2025 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") today announced new icotrokinra (JNJ-2113) data from the comprehensive Phase 3 clinical program and the planned initiation of the first-ever head-to-head study in plaque psoriasis (PsO) seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab. Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor and is being studied in adults and adolescents 12 years of age and older with moderate-to-severe plaque PsO.
Data from the Phase 3 ICONIC-LEADa study, presented as a late-breaking abstract at the 2025 American Academy of Dermatology (AAD) Annual Meeting, show once daily icotrokinra demonstrated significant skin clearance and a favorable safety profile in adults and adolescents 12 years of age and older with moderate-to-severe plaque PsO.i
Key findings from the ICONIC-LEAD study:
At Week 24, nearly half of patients treated with icotrokinra achieved completely clear skin -
46% reached IGA 0 and40% reached PASI 100.1Nearly two-thirds (
65% ) of patients treated with once daily icotrokinra achieved an Investigator's Global Assessment (IGA)b score of 0/1 (clear or almost clear skin) and50% achieved a Psoriasis Area and Severity Index (PASI)c 90 response, compared to8% and4% receiving placebo, respectively (P<0.001 for both endpoints) at Week 16.1Continued skin clearance improvement was reported at Week 24 with
74% of patients treated with icotrokinra achieving IGA 0/1 and65% achieving PASI 90.Similar proportions of patients experienced adverse events (AEs) between icotrokinra (
49% ) and placebo groups (49% ), with no new safety signals identified.1
Results from a subgroup analysis of the ICONIC-LEAD study evaluating icotrokinra in the adolescent population will be presented at a forthcoming medical meeting.
Additionally, topline results from the icotrokinra versus deucravacitinib Phase 3 ICONIC-ADVANCE 1&2d studies are summarized below:
The study met its co-primary endpoints of IGA 0/1 and PASI 90 versus placebo at Week 16.
The study also met all key secondary endpoints at Weeks 16 and 24 that measured superiority to deucravacitinib in patients with moderate-to-severe plaque PsO.ii,iii
Based on the positive outcomes of the ADVANCE 1&2 studies, our partner Johnson & Johnson is initiating the Phase 3 ICONIC-ASCENDe study, the first-ever head-to-head study seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab.
"The new results from the superiority ICONIC-ADVANCE 1&2 studies involving head-to-head comparison with the oral therapeutic deucravacitinib, combined with the results from the ICONIC-LEAD study, reinforce icotrokinra's potential as a paradigm shifting, highly effective first- and only-in-class targeted oral IL-23 receptor antagonist for treatment of psoriasis," said Dinesh V. Patel, Ph.D., President and Chief Executive Officer at Protagonist. "Icotrokinra offers a standout combination of complete skin clearance and favorable safety profile in a once-daily pill and continues to establish itself as a potential first-line systemic therapy for psoriasis. We're very excited about the continued expansion of the ICONIC clinical development program, as exemplified by the initiation of the phase 3 ICONIC-ASCEND superiority study of icotrokinra versus ustekinumab."
Editor's notes:
a. ICONIC-LEAD is a Phase 3 randomized controlled trial (RCT) evaluating the efficacy and safety of icotrokinra compared with placebo in 684 participants (icotrokinra=456; placebo=228) 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 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.iv
c. 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.v PASI 90 corresponds to an improvement of >=
d. ICONIC- ADVANCE 1 & 2 are Phase 3 RCTs evaluating the efficacy and safety of icotrokinra compared with placebo and deucravacitinib in participants with moderate-to-severe plaque PsO with PASI 90 and IGA score of 0/1 with at least a 2-grade improvement as co-primary endpoints.
e. ICONIC-ASCEND is a Phase 3 RCT and the first-ever head-to-head study seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab in moderate-to-severe plaque PsO.
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 & Johnson company.vi The ICONIC clinical development program is being conducted by Johnson and Johnson.
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.vii
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.viii
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.ix,xICONIC-ASCEND will evaluate the efficacy and safety of icotrokinra compared with placebo and ustekinumab in participants with moderate-to-severe plaque psoriasis. ICONIC-PsA 2 (NCT06807424) will evaluate the efficacy and safety of icotrokinra compared to placebo in participants with active psoriatic arthritis.
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.xi It is estimated that 8 million Americans and more than 125 million people worldwide live with the disease.xii Nearly one-quarter of all people with plaque PsO have cases that are considered moderate to severe. xi On Caucasian skin, plaques typically appear as raised, red patches covered with a silvery white buildup of dead skin cells or scale.xiii On skin of color, the plaques may appear darker and thicker and more of a purple, gray or dark brown color.xii Plaques can appear anywhere on the body, although they most often appear on the scalp, knees, elbows and torso.xii 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.xiv 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.xii,xv
About Icotrokinra (JNJ-77242113, JNJ-2113)
Investigational icotrokinra is the first targeted oral peptide designed to selectively block the IL-23 receptor.xviThe IL-23 pathway underpins the inflammatory response in moderate-to-severe plaque psoriasis (PsO), ulcerative colitis (UC) and other diseases.xvii,xviii 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.xix 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.xx
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.xxi,xxii,xxiii
Icotrokinra is being studied in the pivotal Phase 3 ICONIC clinical development program in moderate-to-severe plaque PsO and active psoriatic arthritis and the Phase 2b ANTHEM-UC study in moderately to severely active UC.
About Protagonist
Protagonist Therapeutics is a discovery through late-stage development biopharmaceutical company. Two novel peptides, icotrokinra and rusfertide, derived from Protagonist's proprietary discovery platform are currently in advanced Phase 3 clinical development, with New Drug Application submissions to the FDA expected in 2025. Icotrokinra (JNJ-2113) is a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor ("IL-23R") which is licensed to Johnson & Johnson Innovative Medicines ("JNJ"), formerly Janssen Biotech, Inc. Following icotrokinra's joint discovery by Protagonist and JNJ scientists pursuant to the companies' IL-23R collaboration, Protagonist was primarily responsible for development of icotrokinra through Phase 1, with JNJ 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 into in 2024, under which the Company remains primarily responsible for development through NDA filing. The Company also has a number of pre-clinical stage oral drug discovery programs addressing clinically and commercially validated targets, including the IL-17 oral peptide antagonist PN-881, an oral hepcidin program, and an oral obesity program.
More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at 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 of icotrokinra to shift the psoriasis treatment paradigm. 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 Janssen 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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i Bissonnette, R et al. Icotrokinra, a Targeted Oral Peptide That Selectively Blocks the Interleukin-23-Receptor, for the Treatment of Moderate-to-Severe Plaque Psoriasis: Results Through Week 24 of the Phase 3, Randomized, Double-blind, Placebo-Controlled ICONIC-LEAD Trial. Late-breaking research presentation (Abstract #66708) at the American Academy of Dermatology (AAD) 2024 Annual Meeting. March 2025.
ii Data on file.
iii Data on file.
iv 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 March 2025.
v 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 March 2025.
vi 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 March 2025.
vii 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 March 2025.
viii 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 March 2025.
ix 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 March 2025.
x 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 March 2025.
xi National Psoriasis Foundation. About Psoriasis. Available at: https://www.psoriasis.org/about-psoriasis. Accessed March 2025.
xii National Psoriasis Foundation. Psoriasis Statistics. Available at: https://www.psoriasis.org/content/statistics. Accessed March 2025.
xiii National Psoriasis Foundation. Plaque Psoriasis. Available at: https://www.psoriasis.org/plaque/.Accessed March 2025.
xiv National Psoriasis Foundation. Life with Psoriasis. Available at: https://www.psoriasis.org/life-with-psoriasis/. Accessed March 2025.
xv National Psoriasis Foundation. High Impact Sites. Available at: https://www.psoriasis.org/high-impact-sites/. Accessed Sep March 2025.
xvi 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.
xvii 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.
xviii Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112-124.
xix 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.
xx 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 March 2025.
xxi 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 March 2025.
xxii 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 March 2025.
xxiii 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 March 2025.
SOURCE: Protagonist Therapeutics
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FAQ
What were the key efficacy results for icotrokinra (PTGX) in the Phase 3 ICONIC-LEAD study?
How does icotrokinra's safety profile compare to placebo in the PTGX Phase 3 trial?
What makes icotrokinra (PTGX) unique in the psoriasis treatment landscape?
What is the significance of the upcoming ICONIC-ASCEND study for PTGX?
How did icotrokinra perform against deucravacitinib in the PTGX ICONIC-ADVANCE studies?
