New data show non-inferiority of efficacy for subcutaneous formulation of CT-P13 (biosimilar infliximab) to intravenous formulation of CT-P13 in people with rheumatoid arthritis

Celltrion Healthcare today announced data, at the American College of Rheumatology (ACR) annual meeting, from a study further investigating the efficacy, pharmacokinetics and safety, including immunogenicity, of CT-P13 SC over a one-year treatment period and after switching from CT-P13 IV to CT-P13 SC in people with rheumatoid arthritis (RA).¹ A previous study demonstrated the non-inferiority of CT-P13 SC to CT-P13 IV and compared the efficacy, pharmacokinetics and safety profiles of CT-P13 SC with CT-P13 IV in people with RA over 30 weeks.³

People who received full doses of CT-P13 IV 3 mg/kg at Weeks 0 and 2 were randomly assigned to receive either CT-P13 SC 120 mg via pre-filled syringe biweekly (from Week 6 to Week 28) or CT-P13 IV 3mg/kg every 8 weeks (from Week 6 to Week 22). From Week 30 all people received CT-P13 SC 120 mg via pre-filled syringe biweekly up to Week 54.¹

The efficacy up to Week 54 showed a similar trend between CT-P13 SC and CT-P13 IV arms even after switching from IV to SC treatment at Week 30 in terms of DAS28 (CRP) mean scores, ACR20/50/70 and EULAR-CRP response.¹

In the CT-P13 SC arm, the mean serum concentration before study drug administration increased from Week 6 and generally maintained a consistent level from Weeks 14 to 54 as a result of biweekly CT-P13 SC injections. After switching from IV to SC at Week 30, the mean serum concentration gradually increased from Week 30 and maintained a consistent level up to Week 54.¹

The results after switching from IV to SC treatment at Week 30 were comparable to that of maintaining CT-P13 SC up to Week 54 (up to Week 64 for safety profile). The proportion of people who had anti-drug antibody (ADA) positive results and had post-treatment ADA positive results were comparable between the two arms and numerically lower in the CT-P13 SC arm.¹

“Non-inferiority of efficacy for CT-P13 SC to CT-P13 IV was demonstrated by the change from baseline DAS28 (CRP) at Week 22. The serum concentration of CT-P13 SC was well maintained up to Week 54. Safety results of CT-P13 SC showed similar profiles to CT-P13 IV during the study,” said Professor Rene Westhovens, Rheumatologist at the University Hospitals KU Leuven, Belgium. “Hence, CT-P13 SC showed lower ADA than CT-P13 IV which indicates high trough level potentially leading to better PK pattern and positive efficacy profile. The results show that the novel SC formulation of CT-P13 via pre-filled syringe could provide a favourable benefit to people with an alternative convenient way of administration.”

Celltrion Healthcare also announced data from a first-in-human study of CT-P17, a recombinant humanised monoclonal antibody developed as a biosimilar to the reference product adalimumab. The study was designed to evaluate the safety, including immunogenicity and pharmacokinetics, of CT-P17 (40 mg/0.4 mL) compared with EU-reference adalimumab (40 mg/0.4 mL) in healthy male subjects.²

In this phase 1, randomised, double-blind, active comparator study, healthy male subjects aged 18 to 55 years (N = 30) were randomised in a 1:1 ratio to receive 40 mg of either CT-P17 or EU-reference adalimumab by SC injection.

Single SC doses of 40 mg of CT-P17 or EU-reference adalimumab were well-tolerated and the safety profile of CT-P17, including immunogenicity, was comparable with that of EU-reference adalimumab in these healthy male subjects.

“Overall, the proportion of subjects with positive ADA and neutralising antibodies results after the study drug administration was similar in the two treatment groups,” said Professor Edward Keystone, Senior Consultant Rheumatologist, Mount Sinai Hospital, Toronto, Canada. “Pharmacokinetic results were also comparable between the two treatment arms.”

Mr Hyoung-Ki Kim, Vice Chairman at Celltrion Healthcare, said, “With the availability of the CT-P13 SC, patients could now be treated with infliximab SC before switching to other costly antibodies with a different mechanism of action such as JAK-inhibitors. Celltrion Healthcare will target CT-P13 SC as the preferred agent for second-line treatment in rheumatoid arthritis. Together with the subcutaneous formulation of CT-P13, the development of the biosimilar adalimumab, CT-P17, will offer opportunities in improving access to treatment and increasing treatment options worldwide. Celltrion Healthcare remains highly committed to developing our biosimilar portfolio and delivering value to patients, payers and healthcare providers.”

-- ENDS --

Notes to Editors:

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 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 US FDA approved CT-P13 in April 2016 under the trade name Inflectra^®. CT-P13 intravenous (IV) formulation is approved in more than 91 countries (as of October 2019) 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.⁴ 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.^5,6

The SC formulation of CT-P13 is not currently approved for us. It has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the treatment of people with RA. A phase III study of CT-P13 SC for people with inflammatory bowel disease (IBD) is underway. Celltrion hope to seek expanded indications following the results of this trial.

About CT-P17 (biosimilar adalimumab)

CT-P17 is a recombinant humanised monoclonal antibody that contains the active ingredient adalimumab. Adalimumab is a fully human anti–tumour necrosis factor α (anti-TNFα) monoclonal antibody indicated for the treatment of patients with rheumatoid arthritis (RA), psoriatic arthritis (PsA), ankylosing spondylitis (AS), Crohn’s disease (CD), ulcerative colitis (UC), psoriasis (PsO), hidradenitis suppurativa (HS), uveitis (UV) and juvenile idiopathic arthritis (JIA).

The primary results of the first clinical study of CT-P17 – a phase 1 randomised, double-blind, three-arm, parallel group, single-dose study versus reference adalimumab in healthy male subjects – were recently published and demonstrated comparability in safety profile, immunogenicity and pharmacokinetics (PK) for these healthy male subjects.

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 endeavours to offer high-quality cost-effective solutions through an extensive global network that spans more than 120 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us

Forward-looking statement disclaimer

Certain information set forth in this press release contains statements related to our future business and financial performance and future events or developments involving Celltrion Healthcare that may constitute forward-looking statements, under pertinent securities laws.

These statements may be identified by words such as “will”, “has potential to”, “brings”, “if approved”, “would”, “could”, “opportunity”, “hope”, “is considering” the negative of these words or such other variations thereon or comparable terminology.

In addition, our representatives may make oral forward-looking statements. Such statements are based on the current expectations and certain assumptions of Celltrion Healthcare's management, of which many are beyond its control.

Forward-looking statements are provided to allow potential investors the opportunity to understand management’s beliefs and opinions in respect of the future so that they may use such beliefs and opinions as one factor in evaluating an investment. These statements are not guarantees of future performance and undue reliance should not be placed on them.

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References

¹ Westhovens R, Wiland P, Zawadzki M et al. Efficacy and Safety of a Novel Subcutaneous Formulation of CT-P13 over the 1-year Treatment Period and After Switching from Intravenous CT-P13 in Patients with Active Rheumatoid Arthritis: Results from Part 2 of Phase I/III Randomized Controlled Trial. Poster Number 0548. Presented at ACR 2019.
² Keystone E, Furst D, Boyce M et al. A Pilot Phase 1, Randomized, Double-blind, Two-arm, Parallel Group, Single-dose Study to Evaluate the Safety and Pharmacokinetics of CT-P17 and Humira in Healthy Male Subjects. Poster Number 0503. Presented at ACR 2019.
³ Westhovens R, et al. SAT0170 A novel formulation of CT-P13 for subcutaneous administration: 30 week results from a part 2 of phase phase i/iii randomised controlled trial. Ann Rheum Dis 2019;78:1158-1159.
⁴ 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 November 2019].
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.

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