CELLTRION
23.2.2024 12:41:28 CET | Business Wire | Press release
Celltrion today presented positive two-year results from the extended LIBERTY studies (LIBERTY-CD1 and LIBERTY-UC2) in patients with moderately to severely active Crohn’s disease (CD) and ulcerative colitis (UC). Celltrion also presented endoscopic outcomes from the post-hoc analysis of the LIBERTY-CD study.3
These data were presented as poster presentations at the 19th European Crohn’s and Colitis Organisation (ECCO) annual congress in Stockholm, Sweden.
Two-year results of CT-P13 SC LIBERTY studies
The LIBERTY-CD and LIBERTY-UC studies were continued up to 102 weeks as extension phase treatments, building on the initial LIBERTY trials. The two-year studies assessed the long-term efficacy and safety of CT-P13 SC in patients with Crohn's disease (CD) and ulcerative colitis (UC), respectively.
In the CT-P13 SC LIBERTY-CD study, a total of 180 patients with moderately to severely active CD entered into the extension phase up to Week 102 and received CT-P13 SC 120mg regardless of the previous assigned arm of maintenance phase. 154 (85.6%) patients completed the extension phase, and efficacy results, including clinical remission, clinical response, endoscopic remission, endoscopic response, and corticosteroid-free remission, were generally maintained at Week 102 compared to Week 54. No new safety issues were reported during the extension phase.
In the CT-P13 SC LIBERTY-UC study, a total of 237 patients with moderately to severely active UC entered into the extension phase and received CT-P13 SC regardless of the previous treatment group randomized at the start of maintenance phase. The LIBERTY-UC study demonstrated sustained efficacy through Week 102, with 208 (87%) patients completing the extension phase. Clinical remission, clinical response, endoscopic-histologic mucosal improvement, and corticosteroid-free remission were generally well maintained at Week 102 compared to Week 54. No new safety concerns were observed during the extension phase.
“These data reinforce the efficacy and safety profile of subcutaneous infliximab (CT-P13 SC), and demonstrate it can be used as a long-term treatment option for patients living with moderately and severely active CD and UC patients,” said Professor Jean Frédéric Colombel, Icahn School of Medicine at Mount Sinai, New York and presenting author of the poster presentation. “The combination of convenience with robust clinical data has the potential to offer benefits for patients navigating the challenges of managing IBD.”
Post-hoc analysis of CT-P13 SC LIBERTY-CD study
A separate post hoc analysis investigated the pattern of endoscopic mucosal healing across intestinal segments in patients with CD receiving CT-P13 SC maintenance treatment in the Phase 3 LIBERTY-CD study.
The endoscopy study led to high and consistent endoscopic mucosal healing rates across all segments up to one year, including the terminal ileum, with CT-P13 SC maintenance therapy. The rates of endoscopic complete mucosal healing and partial mucosal healing were significantly higher in the CT-P13 SC arm compared to placebo.
“The early observation of mucosal healing at Week 22 showcases the potential of subcutaneous infliximab treatment in improving patient care,” said Nam Lee, Medical Director at Celltrion. “These study results capture our ongoing commitment to the IBD community and underscore our mission to improve patients’ lives by targeting diseases with high unmet needs.”
A total of 32 abstracts regarding CT-P13 SC were presented at the ECCO congress.
About the subcutaneous (SC) formulation of CT-P13
CT-P13 SC is the world’s first subcutaneous formulation of infliximab. A 120mg fixed dose of CT-P13 SC has been approved for use in 60 countries including the US, UK, EU, Canada, Brazil, Australia and Taiwan, in adults regardless of body weight. The SC formulation of infliximab has the potential to enhance treatment options by providing high consistency in drug exposure and a convenient method of administration.4,5
About Celltrion
Celltrion is a leading biopharmaceutical company based in Incheon, South Korea that specializes in researching, developing, manufacturing, marketing and sales of innovative therapeutics that improve people's lives worldwide. The company’s solutions include world-class monoclonal antibody biosimilars such as REMSIMA®, TRUXIMA® and HERZUMA®, providing broader patient access globally. Celltrion has also received U.S. FDA and EMA approval for VEGZELMA® and YUFLYMA®, FDA approval for ZYMFENTRA™, and EMA approval for REMSIMA®SC. To learn more, please visit www.celltrion.com/en-us.
FORWARD-LOOKING STATEMENT
Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion/Celltrion Healthcare that may constitute forward-looking statements, under pertinent securities laws.
These statements may be identified by words such as “prepares”, “hopes to”, “upcoming”, ”plans to”, “aims to”, “to be launched”, “is preparing, “once gained”, “could”, “with the aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “become available”, “has potential to”, the negative of these words or such other variations thereon or comparable terminology.
In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion/Celltrion Healthcare's management, of which many are beyond its control.
Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.
Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.
Although forward-looking statements contained in this presentation are based upon what management of Celltrion/Celltrion Healthcare believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion/Celltrion Healthcare undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.
References
1 Jean F. Colombel et al., Subcutaneous infliximab (CT-P13 SC) as maintenance therapy for Crohn’s disease: 2 years results of the LIBERTY-CD study. Poster (P902). Presented at ECCO 2024.
2 Bruce E. Sands et al., Subcutaneous infliximab (CT P13 SC) for ulcerative colitis: 2 year extension results of the LIBERTY UC study. Poster (P957). Presented at ECCO 2024.
3 Bruce E. Sands et al., Treatment of patients with moderate-to-severe Crohn’s disease with subcutaneous infliximab leads to an endoscopic response across all segments of the colon and terminal ileum: a post hoc analysis of the LIBERTY-CD study. Poster (P983). Presented at ECCO 2024.
4 Schreiber S et al., Gastroenterology. 2021;160(7):2340-2353.
5 Westhovens R et al., Rheumatology. 2021;60(5):2277-2287.
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240220426905/en/
About Business Wire
Subscribe to releases from Business Wire
Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.
Latest releases from Business Wire
Angelalign Technology Inc. (6699.HK) Says a Preliminary European Court Ruling on Certain Software Features Will Have Minimal Impact on Users12.2.2026 17:58:00 CET | Press release
Angelalign Technology Inc. (6699.HK) (“Angel”) said a ruling by the Unified Patent Court of Düsseldorf, Germany that it preliminarily cease its use of certain software functions that automatically update treatment plans would have minimal impact on the orthodontists and patients who use its clear aligner products. The ruling applies to certain European countries and excludes Spain, Switzerland, United Kingdom and Ireland. Angel will launch iPlan for applicable European users, which is an upgrade feature that has the same reliability and more flexibility for users. Angel denies that the Live Now feature in its iOrtho treatment planning software infringes any valid patents of Align Technology Inc. (ALGN). Angel has already filed an opposition against the patent with the European Patent Office (EPO), arguing that the claimed invention is neither novel nor inventive over the prior art, and is seeking its permanent invalidation. Angel is confident it will overcome the first-instance, non-fi
Model ML Buys Captide to Give Financial AI Agents Citable Corporate Disclosure Data12.2.2026 17:43:00 CET | Press release
Deal follows AI workflow company’s $75m fundraise - one of the largest fintech Series As in history Model ML today announced the acquisition of Captide, the leading financial data layer that turns complex global corporate filings and disclosures into LLM-ready documents and data for AI agents. The acquisition, just weeks after the fintech raised $75m in funding from leading US and UK investors, expands Model ML’s AI workflow builder, enabling its AI agents to reliably retrieve, reason over, and cite global filings. Earlier in 2025, Model ML bought Flippr which added automated PowerPoint generation and verification agents to the platform. Founded in 2024 by Maurits Brinkman and Miquel Trafí Ruiz, Captide’s API takes SEC filings, earnings calls and more and structures them in a way AI models can easily and accurately understand at scale. Its platform already spans 2.5 million+ documents and supports 1 billion embeddings. By bringing Captide into Model ML, clients – including Big 4 accoun
i2c Named Finalist for Best Security or Anti-Fraud Development at Card & Payments Awards Middle East 202612.2.2026 15:00:00 CET | Press release
i2c’s AI-driven Fraud Risk Management solution recognized for delivering impactful results for Middle East clients i2c Inc., a global financial technology innovator, has been named a finalist in the Best Security or Anti-Fraud Development category at The Card & Payments Awards Middle East 2026. The region’s premier awards program recognizes organizations that deliver practical, high-impact innovations to strengthen payment security and protect customers in one of the world’s fastest-growing digital payments markets. i2c was recognized for its AI-driven Fraud Risk Management solution, embedded directly within its unified banking and payments platform and operating in real time at the point of transaction authorization—an increasingly critical capability as digital payments scale across Middle East markets. By evaluating risk at the moment a payment is initiated, rather than after funds are approved, the solution enables earlier detection of fraudulent activity while preserving approval
SLB Awarded Multiple Offshore Drilling Contracts by Mubadala Energy for Tangkulo Deepwater Development in Indonesia12.2.2026 14:00:00 CET | Press release
Contracts support offshore gas development with first gas targeted before end of 2028 Global energy technology company SLB (NYSE: SLB) has been awarded multiple offshore drilling services contracts by Mubadala Energy, the Abu Dhabi headquartered international energy company, for the Tangkulo natural gas deepwater development and associated exploration and appraisal drilling activities in the Andaman Sea, offshore Indonesia. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260212809124/en/ The project will leverage SLB’s offshore and deepwater technologies, including real-time downhole monitoring, to reduce operational risk, improve well placement and strengthen project economics. Under the awards, SLB will work with Mubadala Energy to deliver integrated drilling and well services across the full well life cycle. The scope includes directional drilling, drilling fluids, cementing, wireline, slickline, coiled tubing, well testin
Align Partners Issues Formal Shareholder Proposals to Dentium12.2.2026 13:43:00 CET | Press release
Align Partners Capital Management Inc. (“Align Partners”), a shareholder of Dentium Co., Ltd. (“Dentium” or the “Company”), has submitted formal shareholder proposals for inclusion in the agenda of Dentium’s upcoming 26th Annual General Meeting (“AGM”), urging the Company to strengthen governance practices and improve capital allocation discipline. Align Partners noted that, given shareholder proposals will be presented at this year’s AGM, Dentium should follow the Korea Exchange (KRX) Corporate Governance Key Indicators by publishing the AGM convocation notice at least four weeks prior to the meeting date and adopting an electronic voting system to enhance shareholder participation. Dentium is widely recognized as a global leader in the dental implant industry, supported by superior technology and more than 23 years of long-term clinical data. Despite this strong positioning, Align Partners believes the Company continues to trade at a meaningful discount. As of February 11, 2026, Dent
In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.
Visit our pressroom