CelltrionHealthcare

• The latest clinical trial data for subcutaneous (SC) infliximab (CT-P13 SC), presented at the United European Gastroenterology (UEG) Week 2023 in Copenhagen, further support the potential of CT-P13 SC in patients with inflammatory bowel disease (IBD).
• LIBERTY-CD and LIBERTY-UC are registrational studies in patients with Crohn’s disease (CD) and ulcerative colitis (UC), respectively currently under review by the U.S. Food and Drug Administration (FDA). In the U.S., CT-P13 SC is being reviewed as a novel biologic under the 351 (a) pathway.
• A post-hoc analysis of the LIBERTY-CD and LIBERTY-UC studies demonstrated the efficacy and safety of investigational SC infliximab compared to placebo, exploring the potential of SC infliximab monotherapy and dose escalation as novel treatment approaches in IBD.

INCHEON, South Korea--Celltrion Healthcare today presented Phase III data from the LIBERTY-CD and LIBERTY-UC clinical trials, for the investigational subcutaneous (SC) infliximab in inflammatory bowel disease (IBD) treatment at the United European Gastroenterology (UEG) Week 2023 in Copenhagen.1

Results from the LIBERTY studies, presented during a satellite symposium, evaluated the effectiveness of SC infliximab over placebo in patients with moderately to severely active Crohn's disease (CD) or ulcerative colitis (UC). SC infliximab had a similar safety profile to the placebo during the maintenance period. The proportion of patients who experienced adverse events (AEs), serious AEs, infection in the SC infliximab and placebo groups were generally comparable. No new safety concerns were identified.1

LIBERTY-CD and LIBERTY-UC are registrational studies currently under review by the U.S. FDA as part of a Biologics License Application (BLA) submission. If approved by the FDA, CT-P13 SC would be the first subcutaneous formulation of infliximab.

Post-hoc analyses of the LIBERTY-CD and LIBERTY-UC studies were presented as posters at UEG Week 2023. The first post-hoc analysis examined the possible use of SC infliximab treatment without immunosuppressants and the second evaluated dose escalation in patients with loss of treatment response.

The first post-hoc analysis supports the efficacy and safety of SC infliximab as a monotherapy without immunosuppressants for CD and UC patients. After 54 weeks, there were no statistical differences in efficacy outcomes between monotherapy and combination therapy with immunosuppressants. The overall safety profile during the maintenance period was also comparable between the two groups, suggesting limited benefit of combination therapy with immunosuppressants for IBD patients treated with SC infliximab.2

The second post-hoc analysis evaluated the impact of dose escalation of SC infliximab in managing the loss of response to treatment in IBD patients. The recommended dose for subcutaneous infliximab is 120 mg once every 2 weeks.3 Exploratory results suggest that dose escalation from 120mg to 240mg every two weeks may restore efficacy, while safety profiles, including immunogenicity and the incidence rate of adverse events, were shown to be comparable between patients with or without dose escalation. In both UC and CD studies, patients showed improvement in terms of clinical remission [24.7% (20/81) in UC and 53.8% (21/39) in CD] or endoscopic response [28.2% (11/39) in CD] after dose escalation. Compared to the first dose escalation visits, patients on dose escalation had a statistically significant reduction in modified Mayo score (in UC) and CDAI score (in CD) at Week 54.4

In a separate presentation at UEG Week 2023, real-world data on switching from intravenous (IV) to SC infliximab were evaluated. The findings may help support the practical application of this innovation.5

Stephen B. Hanauer, MD, medical director of the Digestive Health Center at Northwestern Medicine, and professor of medicine at the Feinberg School of Medicine said, “As a healthcare professional dedicated to improving the lives of IBD patients, I am excited to see further data that validate a subcutaneous treatment option allowing more patients in the U.S. to have greater control of their disease.”

Tom Nusbickel, Chief Commercial Officer at Celltrion USA said, “We have already seen the positive impact of subcutaneous infliximab on patients in Europe. We are committed to bringing SC infliximab to the U.S. to increase the therapeutic options for IBD once approved by the FDA which is to be marketed and sold by Celltrion USA.”

The European Commission authorized CT-P13 SC in 2020 for multiple indications including CD and UC. FDA approval decision for CT-P13 SC is anticipated within the fourth quarter of 2023.

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About CT-P13 (biosimilar infliximab)
CT-P13 is developed and manufactured by Celltrion and was the world's first monoclonal antibody biosimilar of reference infliximab. It is indicated for the treatment of eight autoimmune diseases including Crohn’s disease (CD) and ulcerative colitis (UC). It was approved by the European Commission under the trade name Remsima® in September 2013 and launched in major EU countries in early 2015. The U.S. Food and Drug Administration approved CT-P13 in April 2016 under the trade name Inflectra®. Remsima® is authorized in over 100 countries worldwide as of January 2023, with a 55% market share in Europe in 2022.6

Subcutaneous infliximab (CT-P13 SC) has received EU marketing authorization for the treatment of patients with CD, UC, rheumatoid arthritis (RA), ankylosing spondylitis (AS), psoriatic arthritis (PsA), and psoriasis in adult patients. In the United States, CT-P13 SC is being reviewed through the new drug pathway by the U.S. Food and Drug Administration (FDA) for the treatment of CD and UC.

About Celltrion Healthcare
Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients’ access to advanced therapies. Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA Current Good Manufacturing Practice (cGMP) and the EU GMP guidelines. Celltrion Healthcare endeavors to offer high-quality, cost-effective solutions through an extensive global network that spans more than 110 different countries.

For more information, please visit: https://www.celltrionhealthcare.com

About Celltrion USA
Celltrion USA is Celltrion Healthcare’s U.S. subsidiary established in 2018. Headquartered in New Jersey, Celltrion USA is committed to expanding access to innovative biologics to improve care for U.S. patients. Celltrion currently has five biosimilars approved by the U.S. FDA: Inflectra® (infliximab-dyyb), Truxima® (rituximab-abbs), Herzuma® (trastuzumab-pkrb), Vegzelma® (bevacizumab-adcd), and Yuflyma®(adalimumab-aaty). Celltrion USA will continue to leverage Celltrion Healthcare’s unique heritage in biotechnology, supply chain excellence, and best-in-class sales capabilities to improve access to high-quality biopharmaceuticals for U.S. patients.

Important Safety Information

Please refer to the full Summary of Product Characteristics for full prescribing information for CT-P13 SC: https://www.ema.europa.eu/en/documents/product-information/remsima-epar-product-information_en.pdf

References

1 S. Schreiber. (2023, October). Phase 3 Clinical Trials with Subcutaneous Infliximab in Patients with IBD (LIBERTY-CD & UC). In S. Schreiber (Chair), IS-10 Refining the Journey in the Treatment of IBD with Subcutaneous Infliximab [Symposium]. UEG Week 2023, Copenhagen, Denmark.

2 S. Schreiber et al., Efficacy, safety and immunogenicity of Subcutaneous Infliximab (CT-P13 SC) monotherapy versus combination therapy with Immunosuppressants – Post hoc analysis of LIBERTY-CD study and LIBERTY-UC study. Poster PP0757 Presented at UEGW 2023.

3 European Medicines Agency. Subcutaneous Infliximab. Summary of product characteristics. 2023.
https://www.ema.europa.eu/en/documents/product-information/remsima-epar-product-information_en.pdf, Accessed October 2023

4 S. Danese et al., Subcutaneous Infliximab (CT-P13 SC) dose escalation as an option for managing the loss of response in Inflammatory Bowel Disease: Post hoc analysis of LIBERTY-UC study and LIBERTY-CD study. Poster MP362 Presented at UEGW 2023.

5 N. Mathieu. (2023, October). Insights from Clinical Practice: Switching from Intravenous to Subcutaneous Infliximab in Patients with IBD. In S. Schreiber (Chair), IS-10 Refining the Journey in the Treatment of IBD with Subcutaneous Infliximab [Symposium]. UEG Week 2023, Copenhagen, Denmark.

6 Celltrion, Inc. Fourth-Quarter and Full Year 2022 Earnings Release. https://www.celltrion.com/en-us/irs/resultdata