Latest news with #Icotrokinra
Yahoo
22-07-2025
- Business
- Yahoo
Johnson & Johnson seeks first icotrokinra U.S. FDA approval aiming to revolutionize treatment paradigm for adults and adolescents with plaque psoriasis
Icotrokinra is a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor Filing based on unprecedented data package that met all primary endpoints across four Phase 3 studies, including head-to-head superiority comparisons versus deucravacitinib and evaluation of difficult to treat skin sites Submission underscores potential to shift the treatment paradigm for moderate-to-severe plaque psoriasis patients with the standout combination of complete skin clearance, a favorable safety profile, and simplicity of a once daily pill SPRING HOUSE, Pa., July 21, 2025 /PRNewswire/ -- Johnson & Johnson (NYSE: JNJ) today announced the submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking the first approval of icotrokinra, a first-in-class investigational targeted oral peptide that selectively blocks the IL-23 receptor for the treatment of adults and pediatric patients 12 years of age and older with moderate to severe plaque psoriasis (PsO). Icotrokinra is uniquely designed to block the IL-23 receptor, which underpins the inflammatory response in plaque PsO and offers potential in other IL-23-mediated diseases.1,2,3 The application included data from four pivotal Phase 3 studies conducted as part of the ICONIC clinical development program, including ICONIC-LEADa, ICONIC-TOTALb and ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2c. Treatment with icotrokinra met all primary and co-primary endpoints across the development program among adults and pediatric patients 12 years of age and older with moderate-to-severe plaque PsO, demonstrating significant skin clearance and a favorable safety profile in a once-daily pill. Results from the ICONIC-ADVANCE 1 & 2 studies show icotrokinra achieved co-primary endpoints and showed superiority to deucravacitinib in moderate-to-severe plaque PsO. Across all studies, pooled safety data showed a similar proportion of patients experienced adverse events (AEs) between icotrokinra (49.1%) and placebo (51.9%) groups, with no new safety signals identified to date.4,5,6,7,8 "The rapid patient enrollment across our ICONIC clinical program underscores the unmet need for an advanced plaque psoriasis treatment that meaningfully addresses their needs and preferences," said Liza O'Dowd, MD, Vice President, Immunodermatology and Respiratory Disease Area Lead, Johnson & Johnson Innovative Medicine. "Given the breadth and depth of our studies, along with the robust clinical results reported to date, we are confident that icotrokinra has the potential to transform how physicians and patients think about plaque psoriasis care, establishing a new standard in the treatment of this immune-mediated disease." Data submitted to the FDA as part of the NDA include: Results from the Phase 3 ICONIC-LEAD study, presented as a late-breaking abstract at the 2025 American Academy of Dermatology (AAD) Annual Meeting, that showed icotrokinra successfully met the co-primary endpoints of Investigator's Global Assessment (IGA)d score of 0/1 (clear or almost clear skin) and Psoriasis Area and Severity Index (PASI)e 90 compared to placebo at Week 16.4 A subgroup analysis of ICONIC-LEAD, presented at the 2025 World Congress of Pediatric Dermatology (WCPD), which demonstrated pediatric patients 12 years of age and older treated with once daily icotrokinra achieved higher rates of clear or almost clear skin at Week 16 compared to patients receiving placebo with no new safety signals identified.5 Data from the Phase 3 ICONIC-TOTAL study, presented at the 2025 Society for Investigative Dermatology (SID) Annual Meeting, that highlighted the potential of icotrokinra in patients with difficult-to-treat scalp and genital psoriasis.6 Results from the Phase 3 ICONIC-ADVANCE 1 & ICONIC-ADVANCE 2 studies, that further reinforced the overall efficacy profile met co-primary endpoints of IGA 0/1 and PASI 90 versus placebo at Week 16. Icotrokinra also met all key secondary endpoints at Weeks 16 and 24 that measured superiority to deucravacitinib in patients with moderate-to-severe plaque PsO.7,8 Comprehensive results are being prepared for presentation at a future medical meeting. Long-term data from the ICONIC development program, including at least 52-weeks of treatment for ICONIC-LEAD and ICONIC-TOTAL, and results from a randomized withdrawal analysis evaluating the durability of response, are being prepared for presentation at a future medical meeting. Johnson & Johnson has also initiated the Phase 3 ICONIC-ASCENDf study, the first-ever head-to-head study seeking to demonstrate the superiority of an oral pill, icotrokinra, compared to an injectable biologic, ustekinumab, representing an important step forward in psoriasis research.9 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. ICONIC-TOTAL is a Phase 3 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. c. 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. d. 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.10 e. 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.11 PASI 90 corresponds to an improvement of >=90% in PASI score from baseline.11 f. 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.9 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.12 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.13 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.14 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.15,16 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.17,18 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.19 It is estimated that 8 million Americans and more than 125 million people worldwide live with the disease.20 Nearly one-quarter of all people with plaque PsO have cases that are considered moderate-to-severe.20 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.21 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.22 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.22,23 About Icotrokinra (JNJ-77242113, JNJ-2113) Investigational icotrokinra is the first targeted oral peptide designed to selectively block the IL-23 receptor,1 which underpins the inflammatory response in moderate-to-severe plaque PsO, ulcerative colitis and offers potential in other IL-23-mediated diseases.2,3 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.24 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.25 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.26,27,28 Icotrokinra is being studied in the pivotal Phase 3 ICONIC clinical development program in moderate-to-severe plaque psoriasis, including ICONIC-ASCEND; the ICONIC-PSA 1 and ICONIC-PSA 2 studies in 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 or at 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 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 or on request from Johnson & Johnson. Johnson & Johnson does not undertake to update any forward-looking statement as a result of new information or future events or developments. 1 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 3-8.2 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): 220–229.3 Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112–124.4 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 2025.5 Eichenfield, L et al. Efficacy and Safety of Icotrokinra, a Novel Targeted Oral Peptide (IL-23R-inhibitor), in Adolescents With Moderate-to- Severe Plaque Psoriasis: Subgroup Analyses From a Phase 3, Randomized, Double-Blind, Placebo-Controlled Study (ICONIC-LEAD). Presented at the World Congress of Pediatric Dermatology (Abstract #0054). April 2025.6 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 2025.7 Data on file.8 Data on file.9 A Study to Assess Efficacy and Safety of JNJ-77242113 Compared to Placebo and Ustekinumab in Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ASCEND). Identifier NCT0693422. Accessed July 2025.10 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/ Accessed July 2025.11 Thompson Jr, D. How the Psoriasis Area and Severity Index works. Everyday Health. Available at: Accessed July 2025.12 Protagonist Therapeutics. Press release. Protagonist announces advancement of JNJ-2113 across multiple indications. Available at: Accessed July 2025.13 A study of JNJ-2113 in adolescent and adult participants with moderate-to-severe plaque psoriasis (ICONIC-LEAD). Identifier NCT06095115. Accessed July 2025.14 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. Accessed July 2025.15 A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis. Identifier NCT06143878. Accessed July 2025.16 A Study of JNJ-77242113 for the Treatment of Participants With Moderate to Severe Plaque Psoriasis (ICONIC-ADVANCE 2). Identifier NCT06220604. Accessed July 2025.17 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. 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. National Psoriasis Foundation. About Psoriasis. Available at: Accessed July 2025.20 National Psoriasis Foundation. Psoriasis Statistics. Available at: Accessed July 2025.21 National Psoriasis Foundation. Plaque Psoriasis. Available at: Accessed July 2025.22 National Psoriasis Foundation. Life with Psoriasis. Available at: Accessed July 2025.23 National Psoriasis Foundation. High Impact Sites. Available at: Accessed July 2025.24 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 11-14.25 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: Accessed July 2025.26 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: Accessed July 2025.27 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: Accessed July 2025.28 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: Accessed July 2025. Media contact: Meg Farina mfarina@ Investor contact: Lauren Johnson investor-relations@ View original content to download multimedia: SOURCE Johnson & Johnson Sign in to access your portfolio
Miami Herald
26-06-2025
- Business
- Miami Herald
Protagonist Therapeutics to Host Conference Call to Announce an Oral Obesity Development Candidate
Webcast and conference call to be held on Monday, June 30th at 4:30 pm ET, dial in information below NEWARK, CA / ACCESS Newswire / June 26, 2025 / Protagonist Therapeutics, Inc. ("Protagonist" or the "Company") today announced that the company will host a conference call and webcast to announce its oral obesity development candidate and to share in vitro and pre-clinical proof-of-concept study results. Conference Call and Webcast DetailsThe dial-in numbers for Protagonist's investor update on Monday, June 30th at 4:30 pm ET are: US-based Investors: 1-877-407-0752International Investors: 1-201-389-0912Conference Call ID: 13754335 The webcast link for the event can be found here: A replay of the presentation will be available on the Company's Investor Relations Events and Presentations webpage following the event. About ProtagonistProtagonist 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 submissions to the FDA potentially in 2025. Icotrokinra (formerly, JNJ-2113) is a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor ("IL-23R") which is licensed to J&J 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 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 IL-17 oral peptide antagonist PN-881, oral hepcidin program, and oral obesity program. More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at Investor Relations ContactCorey Davis, Advisors+1 212 915 2577cdavis@ Media ContactVirginia Amann, Founder/CEOENTENTE Network of Companies+1 833 500 0061 ext 1virginiaamann@ SOURCE: Protagonist Therapeutics
Associated Press
26-06-2025
- Business
- Associated Press
Protagonist Therapeutics to Host Conference Call to Announce an Oral Obesity Development Candidate
Webcast and conference call to be held on Monday, June 30th at 4:30 pm ET, dial in information below NEWARK, CA / ACCESS Newswire / June 26, 2025 / Protagonist Therapeutics, Inc. ('Protagonist' or the 'Company') today announced that the company will host a conference call and webcast to announce its oral obesity development candidate and to share in vitro and pre-clinical proof-of-concept study results. Conference Call and Webcast Details The dial-in numbers for Protagonist's investor update on Monday, June 30th at 4:30 pm ET are: US-based Investors: 1-877-407-0752 International Investors: 1-201-389-0912 Conference Call ID: 13754335 The webcast link for the event can be found here: A replay of the presentation will be available on the Company's Investor Relations Events and Presentations webpage following the event. 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 submissions to the FDA potentially in 2025. Icotrokinra (formerly, JNJ-2113) is a first-in-class investigational targeted oral peptide that selectively blocks the Interleukin-23 receptor ('IL-23R') which is licensed to J&J 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 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 IL-17 oral peptide antagonist PN-881, oral hepcidin program, and oral obesity program. More information on Protagonist, its pipeline drug candidates and clinical studies can be found on the Company's website at Investor Relations Contact Corey Davis, Ph.D. LifeSci Advisors +1 212 915 2577 [email protected] Media Contact Virginia Amann, Founder/CEO ENTENTE Network of Companies +1 833 500 0061 ext 1 [email protected] SOURCE: Protagonist Therapeutics press release
Yahoo
09-05-2025
- Business
- Yahoo
J&J's oral psoriasis drug helps patients achieve clear skin in late-stage study
(Reuters) -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% of patients with scalp psoriasis and 77% of those with genital psoriasis achieve significantly clear skin compared to 11% and 21% 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. Sign in to access your portfolio
Yahoo
14-04-2025
- Business
- Yahoo
Johnson & Johnson's Oral IL-23, Icotrokinra, Poised to Redefine the Psoriasis Treatment Landscape Following Positive Phase 3 Data, According to Spherix Global Insights
Perceived first-line utility, patient pool expansion, and paradigm-shifting potential distinguish Icotrokinra in the eyes of US dermatologists EXTON, PA, April 14, 2025 (GLOBE NEWSWIRE) -- Johnson & Johnson's recent announcement of positive Phase 3 data for its oral IL-23 receptor antagonist, icotrokinra (JNJ-2113), has sparked notable enthusiasm across the dermatology community. According to the company's recent release, the once-daily oral therapy met all primary and secondary endpoints across both the FRONTIER 1 and FRONTIER 2 studies in moderate-to-severe plaque psoriasis, achieving 65% PASI 90 response and 74% IGA 0/1 at Week 24 with its higher dose regimen. These efficacy outcomes and a favorable safety profile suggest that icotrokinra may become the first oral IL-23 pathway inhibitor to reshape the current psoriasis treatment algorithm. Data from Spherix Global Insights' RealTime Dynamix™: Plaque Psoriasis (US) Q1 2025 report confirms heightened interest in icotrokinra among dermatologists (n=103), with many already envisioning its role as a first-line systemic treatment. While unaided awareness of the Phase 3 results was modest, prompted exposure to the data led to a significant uptick in prescriber enthusiasm. In fact, dermatologists rated icotrokinra as the top pipeline agent by a considerable margin, and they would like to see it approved, with interest and likelihood to prescribe scores surpassing all other late-stage psoriasis assets. Notably, over half of dermatologists reported that icotrokinra would be used as a first-line advanced systemic treatment. At the same time, most agree that its availability would expand the pool of psoriasis patients on advanced treatments—a strong indicator that icotrokinra may help bridge the gap between topical and biologic therapies. Importantly, a sizable portion of patients currently treated with oral small molecules (i.e., Otezla or Sotyktu) who are not considered well-managed may be switched to icotrokinra upon availability, underscoring its potential to disrupt the existing oral systemic market. Dermatologists cited its oral convenience, high response rates, and mechanistic familiarity with successful IL-23 biologics like Skyrizi and Tremfya as primary drivers of interest. Data from Spherix's Special Topix™: The Oral Opportunity in Plaque Psoriasis, 2024 study indicate that the availability of efficacious and safe oral agents is the top unmet need for treating psoriasis. Moreover, most dermatologists believe that oral treatment can be just as efficacious as injectable treatment. Despite the positive momentum, some prescribers remain cautiously optimistic, pointing to the need for real-world data and long-term safety monitoring before making widespread practice changes. However, with robust Phase 3 results and clear differentiation from existing oral therapies, icotrokinra is poised to be a game-changer in moderate-to-severe plaque psoriasis. As J&J advances icotrokinra toward regulatory submission, ongoing dermatologist perception tracking will be critical in determining its commercial potential and ultimate impact on the psoriasis landscape. Spherix continues to monitor the PsO market with these insights and more available via its quarterly RealTime Dynamix™ service, and will continuously evaluate the oral opportunities in psoriasis via the Special Topix™ service. RealTime Dynamix™ is an independent service providing strategic guidance through quarterly or semiannual reports, which include market trending and a fresh infusion of event-driven and variable content with each wave. The reports provide an unbiased view of the competitive landscape within rapidly evolving specialty markets, fueled by robust HCP primary research and our in-house team of experts. is an independent service that includes access to a report or series of reports based on current events or topics of interest in specialty markets covered by Spherix. About Spherix Global Insights Spherix is a leading independent market intelligence and advisory firm that delivers commercial value to the global life sciences industry, across the brand lifecycle. The seasoned team of Spherix experts provides an unbiased and holistic view of the landscape within rapidly evolving specialty markets, including dermatology, gastroenterology, rheumatology, nephrology, neurology, ophthalmology, and hematology. Spherix clients stay ahead of the curve with the perspective of the extensive Spherix Physician Community. As a trusted advisor and industry thought leader, Spherix's unparalleled market insights and advisory services empower clients to make better decisions and unlock opportunities for growth. To learn more about Spherix Global Insights, visit or connect through LinkedIn. For more details on Spherix's primary market research reports and interactive dashboard offerings, visit or register here: NOTICE: All company, brand or product names in this press release are trademarks of their respective holders. The findings and opinions expressed within are based on Spherix Global Insight's analysis and do not imply a relationship with or endorsement of the companies or brands mentioned in this press release. CONTACT: Andy Stankus, Dermatology Franchise Head Spherix Global Insights 4848794284 in to access your portfolio
