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.”

--- Ends---

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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190308005014/en/