CELLTRION-HEALTHCARE

Celltrion Healthcare today announced new 1-year data from a randomised controlled trial to evaluate the pharmacokinetics (PK), efficacy and safety of CT-P13 subcutaneous (SC) formulation compared to the CT-P13 intravenous (IV) formulation in patients with active Crohn’s disease (CD) and ulcerative colitis (UC). Results presented at The European Crohn's and Colitis Organisation (ECCO) 2020 annual congress in Vienna, Austria demonstrated that the SC formulation of CT-P13 was comparable to the IV formulation of CT-P13 in terms of efficacy and safety throughout the 1-year treatment period.¹

In the study, 131 patients were randomised at the maintenance phase (66 to the SC arm and 65 to the IV arm), of whom 105 (80.2%) patients completed the week 54 visit (55 in the SC arm and 50 in the IV arm). After loading doses of IV 5mg/kg at weeks 0 and 2, patients were randomised at week 6 to receive either SC 120 mg (<80kg) or 240 mg (≥80 kg) every 2 weeks in the SC arm, or continued on IV 5 mg/kg every 8 weeks in the IV arm. From week 30 onwards, the IV 5 mg/kg group were switched to either SC 120 or 240 mg based on the patients’ body weight.¹

Professor Shomron Ben-Horin, MD, Department of Gastroenterology, Chaim Sheba Medical Center in Israel, and one of the lead investigators of the trial said, “the 1-year results including switching results show a comparable efficacy and safety profile between CT-P13 SC and IV. These observations support the world’s first infliximab SC formulation as a viable therapeutic agent to expand patients’ treatment options.” Professor Ben-Horin added, “It is exciting to hear that the abstract has been selected as one of the Highlights of ECCO and I highly anticipate the approval decision for the inflammatory bowel disease indication in the coming months.”

The study showed that the mean CDAI and partial Mayo scores decreased over time in both arms until week 30, while comparable improvement in clinical activity was observed at week 54 - after switching the remaining IV patients to SC. The rates of clinical response and remission at week 54 were maintained, and the rate of mucosal healing in CD and UC combined was further improved at week 54. Furthermore, after switching the mean pre-dose serum concentrations in the IV arm increased to a comparable level as the SC arm, and maintained consistent levels until week 54. The overall safety profile during the maintenance phase, and on or after week 30, were comparable between both the SC and IV arms.¹

The results were presented as part of oral presentation ‘OP24: A novel subcutaneous infliximab (CT-P13): 1-year results including switching results from intravenous infliximab (CT-P13) in patients with active Crohn’s Disease and Ulcerative Colitis’, which was selected for inclusion in the Highlights of ECCO by organisers.

“CT-P13 SC (Remsima^® SC) is the first and only subcutaneous infliximab to be available in Europe offering patients who are starting or switching anti-TNF-α therapy with the proven benefits of infliximab in a more convenient form. Starting with Germany, we have started launching the new subcutaneous infliximab country by country by establishing local operations across major European countries, building our commercial capabilities and strengthening our relationships with stakeholders across these markets” said Mr. Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare.

Celltrion is seeking approval for the inflammatory bowel disease (IBD) indication for CT-P13 SC (Remsima^® SC) in mid-2020, following EU marketing authorisation for the treatment of people with rheumatoid arthritis in late 2019.

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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.² They affect an estimated 5 million people globally;³ IBDs account for substantial costs to the healthcare system and society; the direct healthcare costs of IBDs are estimated to be €4.6-5.6 billion per year.⁴

About CT-P13 (biosimilar infliximab)^{5 ,6 ,7}
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 RA 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 U.S. Food and Drug Administration approved CT-P13 in April 2016 under the trade name Inflectra^® . CT-P13 is approved in more than 94 countries (as of February 2020) including the US, Canada, Japan and throughout Europe.

CT-P13 IV is usually given as 3mg per kg/body weight in RA and as 5mg per kg/body weight for the other indications. Infliximab IV is given as an infusion over two hours. All patients are monitored for any reactions during the infusion and for at least one to two hours afterwards. Celltrion has also developed a subcutaneous (SC) formulation of infliximab that has three administration options; via a pre-filled pen (auto injector), pre-filled syringe or pre-filled syringe with needle safeguard. The SC formulation has the potential to enhance treatment options for the use of infliximab biosimilar by providing high consistency in drug exposure and a convenient method of administration.

CT-P13 SC has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) and EU marketing authorisation for the treatment of people with RA. Celltrion has submitted a further variation to the marketing authorisation of CT-P13 SC to extend the indication to other disease areas including inflammatory bowel disease. In the United States, Remsima^® SC will be reviewed through the new drug pathway with the expectation of receiving US Food and Drug Administration (FDA) approval by 2022.

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 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us

References

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¹ Ben-Horin, S, et al. A novel subcutaneous infliximab (CT-P13): 1-year results including switching results from intravenous infliximab (CT-P13) in patients with active Crohn’s Disease and Ulcerative Colitis. Oral presentation (OP24) Presented at ECCO 2020.
² Molodecky, N. A, et al. (2012). Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology, 142(1), 46-54. Retrieved from: www.gastrojournal.org/article/S0016-5085(11)01378-3/pdf [Last accessed February 2020].
³ The European Federation of Crohn’s & Ulcerative Colitis Associations. (n.d). What is IBD? Science
Retrieved from www.efcca.org/en/science [Last accessed February 2020].
⁴ Burisch, J, et al. (2013). The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis, 7(4), 322-337.Retrieved from: https://www.sciencedirect.com/science/article/pii/S1873994613000305?via%3Dihub [Last accessed February 2020].
⁵ Yoo DH, Jaworski J, Matyska-Piekarska E et al. A Novel Formulation of CT-P13 (Infliximab Biosimilar) for Subcutaneous Administration: One Year Results from Part One of a Phase I/III Randomised Controlled Trial in Patients with Rheumatoid Arthritis. Poster (FRI0128) Presented at EULAR 2019.
⁶ Westhovens R, Wiland P, Zawadzki M et al. A Novel Formulation of CT-P13 (Infliximab Biosimilar) for Subcutaneous Administration: 30-week Results from Part Two of a Phase I/III Randomised Controlled Trial in Patients with Rheumatoid Arthritis. Poster (SAT0170) Presented at EULAR 2019.
⁷ European Medicines Agency Summary of Product Characteristics (SmPC). CT-P13. Available at http://www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/002576/WC500150871.pdf [Last accessed February 2020].

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