New subcutaneous formulation of Celltrion Healthcare's CT-P13 (biosimilar infliximab) shows positive Phase 1 results for the treatment of IBD in data presented at UEG Week Barcelona 2019

Celltrion Healthcare today announced new data from a Phase 1 pivotal study to evaluate the pharmacokinetics (PK), efficacy and safety of CT-P13 SC compared to the CT-P13 IV formulation in people with inflammatory bowel disease (IBD). Results presented at UEG Week 2019 in Barcelona, Spain demonstrated non-inferiority of CT-P13 SC compared to CT-P13 IV in the PK primary endpoint at pre-dose level (C_trough) at week 22, and in the secondary endpoints efficacy and safety up to week 30.

In the study, 136 patients were enrolled and 131 were randomised (66 to CT-P13 SC and 65 to CT-P13 IV). After loading doses of IV 5mg/kg at weeks 0 and 2, patients were randomised at week 6 to receive either CT-P13 SC 120mg (<80kg) or 240mg (?80kg) every 2 weeks in the CT-P13 SC arm, or CT-P13 IV 5mg/kg every 8 weeks in the CT-P13 IV arm.

The Phase 1 pivotal study demonstrated that CT-P13 SC showed non-inferiority in PK to CT-P13 IV as determined by the trough concentration, pre-dose level (C_trough) at week 22.

In terms of efficacy, both clinical response and remission in patients were induced and maintained, and the overall efficacy results of CT-P13 SC were comparable. The combined clinical remission rates for CD and UC patients at week 30 were comparable between CT-P13 IV and CT-P13 SC (66.7%, 44 out of 66 patients in CT-P13 SC arm and 54.7%, 35 out of 64 patients in CT-P13 IV, p=0.1620). The safety profile of CT-P13 SC was comparable to CT-P13 IV. In addition, fewer patients were found to have positive anti-drug-antibodies with CT-P13 SC compared to CT-P13 IV.

A subcutaneous formulation of CT-P13 has the potential to enhance treatment options for the use of biosimilar infliximab by providing high consistency in drug exposure and a convenient method of administration.

"CT-P13, a biosimilar of in?iximab, has already been thoroughly characterized as a prime choice for intravenous infliximab therapy in t he past with dedicated trials demonstrating clinical similarity in comparison with the originator molecule in both RA and IBD. The new, highly innovative SC formulation of in?iximab has been speci?cally developed to address unmet needs in maintenance therapy. Our results from the ongoing development program for SC CT-P13 infliximab are promising. CT-P13 SC infliximab has the potential to become the most innovative biosimilar treatment ? improving convenience and allowing patients to have more control of their treatment in addition to direct clinical benefits," said Professor Stefan Schreiber, Director of the Clinic for Internal Medicine at Kiel Campus of the University Hospital Schleswig-Holstein in Germany and first author of the study. "Not without reason the IV/SC sequence therapy that has been implemented into most development paths for novel molecules."

"A new subcutaneous formulation of in?iximab has the potential to change the way patients manage their condition on a day-to-day basis, o?ering them greater choice and convenience in the long term. Furthermore, o?ering patients the option to self-administer will reduce demand on healthcare systems, by lessening patient time spent in hospitals, keeping patients out of clinics and providing clinicians with additional time to spend with other patients," said Mr. Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare. "This new formulation could create a new treatment paradigm with IV/SC sequence therapy making treatment affordable, convenient and personalised."

Celltrion seeks approval for the inflammatory bowel disease (IBD) indication for CT-P13 SC in the second half of 2020.

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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.¹ They affect an estimated 5 million people globally;² 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.³

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 October 2019) 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/

References

¹ 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 October 2019].
² The European Federation of Crohn's & Ulcerative Colitis Associations. (n.d). What is IBD? Science
Retrieved from www.efcca.org/en/science [Last accessed October 2019].
³ Burisch, J, et al. (2013). The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis, 7(4), 322-337.Retrived from: https://www.sciencedirect.com/science/article/pii/S1873994613000305?via%3Dihub [Last accessed October 2019].