CELLTRION
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.
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