Latest news with #ANTHEM-UC
Yahoo
18-03-2025
- Business
- Yahoo
Johnson & Johnson (NYSE:JNJ) Gains FDA Fast Track For Nipocalimab In Treating Sjogren's Disease
Johnson & Johnson experienced an 11% share price increase over the last quarter, coinciding with pivotal product-related milestones. The FDA's granting of Fast Track Designation for nipocalimab to treat Sjogren's disease marks a significant advancement, following its earlier Breakthrough Therapy Designation. This recognition could propel investor confidence, given the potential for accelerating therapeutic development addressing unmet needs. Additionally, Health Canada's approval for LAZCLUZE and the positive results from the ANTHEM-UC study contribute to the company's strengthened therapeutic portfolio. Despite broader market declines, with indices like the Dow Jones and Nasdaq experiencing downturns, Johnson & Johnson's recent regulatory wins and promising clinical data may anchor its investor appeal. The broader market trends include a minor 1.7% uptick over the past week and a 10% increase yearly, positioning JNJ's performance as a standout amid market challenges. This optimism reflects the company's resilience in achieving key development milestones, irrespective of broader economic uncertainties. Assess the downside scenarios for Johnson & Johnson with our risk evaluation. Diversify your portfolio with solid dividend payers offering reliable income streams to weather potential market turbulence. Over the last five years, Johnson & Johnson's total shareholder return reached 68.59%. This period featured regulatory and legal challenges but also significant advancements in product approvals and strategic maneuvers. Noteworthy is the January 2022 FDA approval for XARELTO® to treat pediatric venous thromboembolism, bolstering the company's pharmaceutical segment. Another key development was J&J's announcement in November 2021 about its plan to separate the Consumer Health division, signaling a business focus shift. The fiscal landscape was marked by a large one-off $7.8 billion loss impacting the financial results to December 2024, yet J&J continued its tradition of dividend increases, exemplified by the early 2025 rise to $1.24 per share. Meanwhile, despite J&J's underperformance compared to the broader US market's 10% climb in the past year, the company's initiatives in pharmaceuticals and legal resolutions anchored the longer-term investor confidence in the firm's potential amidst industry challenges. Hold shares in Johnson & Johnson? Setup your portfolio in Simply Wall St to seamlessly track your investments and receive personalized updates on your portfolio's performance. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include NYSE:JNJ. Have feedback on this article? Concerned about the content? with us directly. Alternatively, email editorial-team@ Sign in to access your portfolio
Associated Press
10-03-2025
- Health
- Associated Press
Protagonist Reports Positive Top Line Results From Phase 2b Study of Icotrokinra Showing Potential to Transform the Treatment Paradigm for Patients With Ulcerative Colitis
Clinical response rate of 63.5% and clinical remission rate of 30.2% achieved at Week 12 with the highest dose, which continued to improve through Week 28 All three doses met the primary endpoint of clinical response at Week 12, with a favorable safety profile These results in ulcerative colitis build on strong data recently reported for the plaque psoriasis Phase 3 program NEWARK, CALIFORNIA / ACCESS Newswire / March 10, 2025 / Protagonist Therapeutics, Inc. ('Protagonist' or the 'Company') today announced positive topline results from ANTHEM-UC, a Phase 2b 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 (UC). The study conducted by Protagonist's collaboration partner, Johnson & Johnson, met its primary endpoint of clinical responsea in all icotrokinra dose groups evaluated. Additionally, the study demonstrated clinically meaningful differences versus placebo in key secondary endpoints of clinical remissionb, symptomatic remission and endoscopic improvement at Week 12. Key findings from the ANTHEM-UC study (n=252) are summarized below: All three doses of once daily icotrokinra met the primary endpoint of clinical response at Week 12. A response rate of 63.5% for patients treated with the highest dose of icotrokinra was achieved at Week 12 versus 27.0% for placebo (p<0.001). 30.2% of patients treated with the highest dose of icotrokinra demonstrated clinical remission at Week 12 versus 11.1% of patients who received placebo (p<0.001). Clinical remission and response rates continued to improve through Week 28.i Icotrokinra was well tolerated with the proportions of participants reporting one or more adverse events (AEs) being similar between the icotrokinra dose groups and the placebo group.i 'We are thrilled with the impressive results of once daily oral icotrokinra in the ANTHEM Phase 2 ulcerative colitis study, broadening the potential utility of this first-in-class and only-in-class oral IL-23 receptor antagonist from psoriasis to inflammatory bowel diseases,' said Dinesh V. Patel, Ph.D., President and Chief Executive Officer at Protagonist. 'This is another example of Protagonist's oral peptide platform delivering transformative, paradigm shifting outcomes in the hands of a world-leading development partner. Icotrokinra has the potential to transform the treatment landscape in UC through its distinctive profile of efficacy, safety, tolerability, and convenience of a once-daily oral treatment. We eagerly await icotrokinra's further progression into more advanced clinical studies in ulcerative colitis and Crohn's disease.' Comprehensive results from the ANTHEM-UC study are being prepared for presentation at upcoming medical congresses by our partner. Editor's notes: 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. 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 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 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 About Icotrokinra (JNJ-77242113, JNJ-2113) Investigational icotrokinra is the first targeted oral peptide designed to selectively block the IL-23 receptor,iv which underpins the inflammatory response in moderate-to-severe plaque psoriasis, ulcerative colitis and offers potential in other IL-23-mediated diseases.v,vi Icotrokinra binds to the IL-23 receptor with single-digit picomolar affinity and demonstrated potent, selective inhibition of IL-23 signaling in human T 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 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 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 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 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 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 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 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 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. Investor Relations Contact Corey Davis, Ph.D. LifeSci Advisors +1 212 915 2577 [email protected] Media Contact Virginia Amann, Founder/CEO +1 833 500 0061 ext 1 ENTENTE Network of Companies [email protected] i Data on file. ii A Study of JNJ-77242113 in Participants With Moderately to Severely Active Ulcerative Colitis (ANTHEM-UC). Identifier NCT06049017. Accessed March 2025. iii Crohn's & Colitis Foundation. What is ulcerative colitis? Available at: Accessed March 2025. iv 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. v 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. vi Tang C, et al. Interleukin-23: as a drug target for autoimmune inflammatory diseases. Immunology. 2012 Feb; 135(2): 112-124. vii 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. viii 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 March 2025. ixProtagonist 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 March 2025. x 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 March 2025.
