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Celltrion Healthcare Presents Positive Top-Line Efficacy and Safety Results for CT-P17 in the Treatment of Rheumatoid Arthritis

2020年11月03日 AM04:00
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INCHEON, South Korea

New data to be presented at the American College of Rheumatology (ACR) Convergence 2020 demonstrate that the efficacy, pharmacokinetics (PK) and overall safety of CT-P17, a proposed high concentration (100mg/mL) and citrate-free adalimumab biosimilar, is comparable to reference adalimumab in the treatment of rheumatoid arthritis (RA) patients.

The randomised, double-blind, phase III study investigated the equivalence of CT-P17 to reference adalimumab in terms of efficacy, pharmacokinetics (PK) and overall safety over 24 weeks.1 648 patients with active moderate-to-severe RA despite methotrexate (MTX) treatment were randomly assigned to receive 40mg of CT-P17 or reference adalimumab every 2 weeks up to week 24.

Results demonstrated CT-P17 has equivalent efficacy to reference adalimumab – the ACR20 response rate at week 24 was 82.7% (268/324) for both CT-P17 and reference adalimumab. Similar additional secondary efficacy endpoints were seen in terms of ACR20/50/70 response rates, mean DAS28 (CRP), clinical disease activity index (CDAI) and simplified disease activity index (SDAI) and EULAR (CRP) response. The PK results in terms of mean Ctrough of adalimumab up to week 24 were slightly higher for CT-P17 and the mean Ctrough was generally lower in the anti-drug antibody (ADA) positive subgroup than the ADA negative subgroup in both treatment groups. The safety profile of CT-P17 up to week 24 was comparable to that of the reference adalimumab as the majority of events were grade 1 or grade 2 in intensity.1

“These phase III results show a comparable PK, efficacy and safety profile between CT-P17 and the reference adalimumab, building on evidence demonstrating that CT-P17 is equivalent to reference adalimumab for the treatment of rheumatoid arthritis”, said Professor Edward Keystone, Senior Consultant Rheumatologist, Mount Sinai Hospital, Toronto, Canada. “These promising study results support the use of CT-P17, the first adalimumab biosimilar with high concentration and citrate-free formulation as an alternative option for eligible patients with rheumatoid arthritis.”

Further data presented by Celltrion Healthcare at ACR Convergence 2020 investigated the PK and safety of CT-P17 in comparison to EU-approved adalimumab (EU- adalimumab) and US- licensed adalimumab (US- adalimumab) in healthy subjects up to 10 weeks. In this phase I, randomised, double-blind, single-dose study, 312 healthy subjects aged 19 to 55 years were randomised in a 1:1:1 ratio to receive either CT-P17, EU- adalimumab or US- adalimumab after a single subcutaneous (SC) injection of 40mg (100mg/mL). The results showed that the 90% confidence intervals (CI) for the geometric least squares mean ratio of each of the primary PK parameters (AUC0-inf, AUC0-last, and Cmax) were within the predefined equivalence margin of 80% to 125%. The overall safety profile was comparable, and the number of subjects who had positive ADA and neutralising ADA (NAb) results were also similar among the three treatment groups.2

Celltrion Healthcare also presented PK and safety data for two delivery methods for CT-P17, the auto-injector (AI) and pre-filled syringe (PFS). As part of the study, 193 healthy subjects were randomly split into two groups to receive 40mg of either CT-P17 AI or CT-P17 PFS. Following a single SC administration of CT-P17 via AI, mean peak and total systemic exposure (AUC0-inf, AUC0-last and Cmax) were equivalent with those of CT-P17 PFS, which indicates that CT-P17 AI could be a viable alternative administration option.3

— ENDS —

Notes to editors:

About CT-P17 (biosimilar adalimumab)

CT-P17 is a recombinant human 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). CT-P17 is the first proposed high concentration (100mg/mL) adalimumab biosimilar with citrate-free formulation, meaning it causes less pain upon injection.

A phase I randomised, double-blind, three-arm, single-dose study demonstrated PK and safety equivalence of CT-P17 to the high concentration (100mg/mL), citrate-free formulation of both US- and EU- sourced reference adalimumab in healthy subjects.2 A phase III randomised, double-blind study demonstrated the equivalence efficacy to CT-P17 at week 24 to reference adalimumab in patients with moderate-to-severe active rheumatoid arthritis.1 A phase I, randomised, open-label, parallel group, single-dose study demonstrated PK equivalence of CT-P17 auto-injector (AI) and pre-filled syringe (PFS) in healthy subjects.3

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

Forward Looking Statement

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/Celltrion Healthcare that may constitute forward-looking statements, under pertinent securities laws.

These statements may be identified by words such as “prepares”, “hopes to”, “upcoming”, ”plans to”, “aims to”, “to be launched”, “is preparing, “once gained”, “could”, “with the aim of”, “may”, “once identified”, “will”, “working towards”, “is due”, “become available”, “has potential to”, 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/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.

Such forward-looking statements necessarily involve known and unknown risks and uncertainties, which may cause actual performance and financial results in future periods to differ materially from any projections of future performance or result expressed or implied by such forward-looking statements.

Although forward-looking statements contained in this presentation are based upon what management of Celltrion/Celltrion Healthcare believes are reasonable assumptions, there can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Celltrion/Celltrion Healthcare undertakes no obligation to update forward-looking statements if circumstances or management’s estimates or opinions should change except as required by applicable securities laws. The reader is cautioned not to place undue reliance on forward-looking statements.

References


1 J. Kay., et al. (2020). A Randomized, Double-Blind, Phase 3 Study to Compare the Efficacy and Safety of a Proposed High Concentration (100 mg/mL) Adalimumab Biosimilar (CT-P17) with Reference Adalimumab in Patients with Moderate-to-Severe Active Rheumatoid Arthritis. Poster Presented at ACR Convergence 2020.

2 Yu KS, et al. (2020). Pharmacokinetics and Safety of CT-P17, a Proposed High Concentration (100 mg/mL) Adalimumab Biosimilar, in Comparison with EU-Approved Adalimumab and US-Licensed Adalimumab; Results of a Phase 1, Randomized, Double-blind, Three-arm, Single-dose Study in Healthy Subjects. Poster Presented at ACR Convergence 2020.

3 E. Keystone, et al. (2020). A Phase 1, Randomized, Open-label, Parallel Group, Single-dose Study to Compare the Pharmacokinetics and Safety of the Auto-injector and Pre-filled Syringe of CT-P17, a Proposed, Higher Concentration Biosimilar (100 mg/mL) Adalimumab, in Healthy Subjects. Poster Presented at ACR Convergence 2020.

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