Celltrion Healthcare showcases initial data from year-long study for subcutaneous formulation of CT-P13 (biosimilar infliximab) in patients with Crohn’s disease

New data presented at the 14th congress of European Crohn’s and Colitis Organisation (ECCO) show that the subcutaneous (SC) formulation of CT-P13 is comparable in terms of efficacy and safety with the intravenous (IV) formulation of CT-P13 for the treatment of patients with Crohn’s Disease (CD) up to week 54.¹

The randomised, controlled phase I study evaluated efficacy, pharmacokinetic (PK) parameters and the overall safety profile of CT-P13 SC throughout the 1-year treatment period.

In the study, 44 patients with moderate to severe CD were randomly assigned into four cohorts; one group receiving CT-P13 IV 5mg/kg every 8weeks and the other three receiving different doses of CT-P13 SC (120mg/180mg/240mg) bi-weekly up to week 54. From week 6 to week 30, the results showed comparable overall clinical response of CT-P13 SC to CT-P13 IV with similar CDAI-70 scores, whereas clinical remission appears to be numerically higher in the SC cohorts at week 54. The safety profiles of CT-P13 in the SC cohorts were comparable to CT-P13 IV up to week 54.¹

Celltrion also presented PK and overall safety profile data for two administration methods for CT-P13 SC - auto-injection (AI) and pre-filled syringe (PFS). As part of the study, 218 healthy subjects were randomly split into two groups to receive 120mg of CT-P13 SC via AI or PFS for 12 weeks. The results showed a similar PK and safety profile between CT-P13 SC being administered via AI and PFS, however the study showed administration via AI led to fewer injection site reactions and reduced pain.² AI also has the potential benefit of being simpler to self-administer and reducing patient distress compared to administration via PFS, meaning that this could be a preferable administration option for CT-P13 SC.

Professor Walter Reinisch, Director of clinical IBD study group, Department of Gastroenterology and Hepatology, Medizinische Universität Wien said, “The year-long results show a comparable PK, efficacy and safety profile between CT-P13 SC and IV. This data is encouraging in showing that CT-P13 SC is safe and efficacious as a treatment for Crohn’s disease and the SC formulation has the potential to be used as an alternative infliximab treatment in the future. CT-P13 SC could become a game-changer in biosimilar treatment by improving convenience and allowing patients to be more in control of their treatment.”

Mr. Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare said, “The availability of a subcutaneous version of CT-P13 will be an important milestone for our biosimilars portfolio, expanding the range of treatment options for the millions of patients living with chronic inflammatory diseases such as Crohn’s disease. We are committed to providing physicians with treatment options that suit the individual needs and preferences of their patients, whether that is intravenous or subcutaneous. If CT-P13 SC is approved in Europe, the dual formulation of infliximab could offer patients a more convenient treatment option.”

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Notes to editors:

About inflammatory bowel disease

Inflammatory bowel diseases (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), are chronic disabling gastrointestinal disorders that impact every aspect of a patient’s life.³ They affect an estimated 5 million people globally.⁴ IBD accounts for substantial costs to the healthcare system and society; the direct healthcare costs of IBD is estimated to be €4.6-5.6 billion per year.⁵

About CT-P13 (biosimilar infliximab)

CT-P13 is developed and manufactured by Celltrion, Inc. and was the world’s first monoclonal antibody biosimilar approved by the European Commission (EC). It is indicated for the treatment of eight autoimmune diseases including rheumatoid arthritis and IBD. It was approved by the EC under the trade name Remsima® in September 2013 and launched in major EU countries in early 2015. The US FDA approved CT-P13 in April 2016 under the trade name Inflectra^®. CT-P13 is approved in more than 89 countries (as of Nov 2018) including the US, Canada, Japan and throughout Europe.

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 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 120 different countries. For more information please visit: http://www.celltrionhealthcare.com/

¹ Reinisch W, et al. A novel formulation of CT-P13 (infliximab biosimilar) for subcutaneous administration: 1-year result from a phase 1 open-label randomised controlled trial in patients with active Crohn’s disease. European Crohn’s and Colitis Organisation 2019. Abstract no: A-1103.
² Schreiber S, et al. Development of a novel auto-injector of subcutaneous CT-P13 infliximab: Phase 1 randomised, open-label, single-dose trial to compare the pharmacokinetics and safety to pre-filled syringe in healthy subjects. European Crohn’s and Colitis Organisation 2019. Abstract no: A-1165.
³ Molodecky NA, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012; 142(1)46–54.
⁴ The European Federation of Crohn’s & Ulcerative Colitis Associations. What is IBD? Science. Available at: http://www.efcca.org/en/science.
⁵ Burisch J, et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013)7,322-337.

ABSTRACT NUMBER: A-1103 DATE AND TIME OF PRESENTATION: March 8th, 17:47 – 17:53 CET

ABSTRACT NUMBER: A-1165 DATE AND TIME OF PRESENTATION: March 8th, 12:30 CET

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