Business Wire

New data presented at UEG Week Virtual 2020 show positive association between Remsima® SC pre-dose level with efficacy outcomes

Share

Celltrion Healthcare today announced two new data sets relating to the use of the subcutaneous formulation of infliximab, Remsima® SC (CT-P13 SC), in inflammatory bowel disease (IBD) at a poster presentation at UEG Week Virtual 2020.

The first study investigated the association between the pre-dose serum of infliximab concentrations, with clinical efficacy and fecal calprotectin (FC) response.1 The results show a positive association between CT-P13 SC exposure with both efficacy and FC outcomes in patients with Crohn’s disease (CD) and ulcerative colitis (UC).1

Among 54 patients in the SC arm who have completed the CT-P13 SC maintenance treatment up to Week 54, 42 (77.8%) patients achieved clinical remission at Week 54. 1 Upon subgrouping patients according to quartiles of drug level exposure, the analysis shows that as a proportion, patients with the highest infliximab exposure (>26.7 μg/mL) achieved highest efficacy outcomes.1

The second study presented investigated the accuracy of the use of FC in monitoring mucosal change in a controlled trial of CT-P13 SC and IV for patients with moderate to severe UC.2 The results of this trial demonstrate that FC levels are associated with changes in status of mucosal inflammation, and specifically with improved endoscopic activity in UC patients who are treated with CT-P13 SC.2

A total of 68 UC patients were included in the multicentre, randomised controlled pivotal trial with 33 patients in the SC arm and 35 in the IV arm.2 At baseline, the median FC level in the entire cohort was 880 µg/g (786 µg/g and 978 µg/g in the SC and IV arms, respectively). 59 of 68 (86.8%) patients achieved FC level > 250 µg/g overall. In the SC arm, this accounted for 29 of 33 patients (87.9%), and in the IV arm, 30 of 35 patients (85.7%). The proportion of patients with FC level > 250 µg/g decreased to 39.0% (23/59) overall at week 22; with 44.4% (12/27) in the SC arm, and 34.4% (11/32) in the IV arm.2

Professor Walter Reinisch, Director of Clinical IBD Study Group, Department of Gastroenterology and Hepatology, Medical University of Vienna said, “These promising results support the use of the subcutaneous formulation of Remsima® in inflammatory bowel disease as an alternative option for eligible patients with UC and CD. In addition, the use of FC for monitoring the mucosal response to infliximab SC presents a viable, non-invasive choice for monitoring treatment – providing patients and clinicians with greater flexibility to suit their needs.”

--- 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 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.5

About CT-P13 (biosimilar infliximab)6,7,8

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 October 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 received EU marketing authorisation for the treatment of people with RA and IBD in November 2019 and July 2020, respectively. In the United States, Remsima® SC will be reviewed through the new drug pathway by the US Food and Drug Administration (FDA) with the outcome expected 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

1 Ye, B.D., et al. (2020). Exposure-response relationship of subcutaneous infliximab (CT-P13 SC) in patients with active Crohn’s disease and ulcerative colitis: analysis from a multicentre, randomized controlled pivotal trial. Moderated Poster Presentation (P0482). Presented at UEG Week Virtual 2020.

2 Reinisch, W., et al. (2020). Evaluation of clinical relationship between fecal calprotectin and endoscopic findings in ulcerative colitis patients treated with infliximab (ct-p13) subcutaneous and intravenous therapy: results from a multicenter, randomized, controlled pivotal trial. E-Poster Presentation (P0593). Presented at UEG Week Virtual 2020.

3 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 2020].

4 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 2020].

5 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 October 2020].

6Yoo DH, Jaworski J, Matyska-Piekarska E et al. (2019). 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.

7 Westhovens R, Wiland P, Zawadzki M et al. (2019). 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.

8 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 October 2020].

Contact information

Zuzanna Grzeskiewicz
zgrzeskiewicz@hanovercomms.com
+44 (0)20 3817 6597

Preetika Ramjoorawon
pramjoorawon@hanovercomms.com
+44 (0)20 3817 6718

About Business Wire

For more than 50 years, Business Wire has been the global leader in press release distribution and regulatory disclosure.

Subscribe to releases from Business Wire

Subscribe to all the latest releases from Business Wire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from Business Wire

PerkinElmer Launches Industry First No-Wash Immunoassay For Phospho Ubiquitin Ser65 to Help Drive Neuroscience Disease and Therapeutics Research Forward26.10.2020 22:05:00 EETPress release

PerkinElmer, Inc., a global leader committed to innovating for a healthier world, today launched the life science industry’s first no wash Ubiquitin phosphorylation at Serine 65 immunoassay for studying defective mitophagy biological mechanisms that have been broadly associated with diseases such as Parkinson’s and Alzheimer’s. The new PerkinElmer Cisbio HTRF® Phospho-Ubiquitin (Ser65) Cellular Kit takes analysis efficiency and accuracy to the next level compared to existing techniques such as Western blot and is aimed at helping scientists discover new therapeutic candidates earlier in the disease cycle. The innovative assay leverages TR-FRET technology to bring high sensitivity across a wide range of analytes and greater study specificity to the Phospho-Ubiquitin (Ser65) intersection point that has been shown to play a key role in mitophagy dysfunction and breakdowns in the complex network between neurons and glial cells which can lead to neurodegenerative disease. Efficient and stre

NetApp Brings Optimization and Enterprise Data Services to the Cloud26.10.2020 19:00:00 EETPress release

Global, cloud-led, data-centric software company NetApp® (NASDAQ: NTAP) today unveiled a groundbreaking serverless and storageless solution for containers from Spot by NetApp, a new autonomous hybrid cloud volume platform, and cloud-based virtual desktop solutions. NetApp’s new capabilities help simplify and optimize multicloud management for the highest performance at a low cost, offering true portability for data-rich cloud applications and delivering comprehensive workplace solutions across hybrid cloud environments. “To thrive in the new normal, digital transformation has become a business imperative. To succeed, businesses need to optimize their hybrid multicloud IT architectures,” said NetApp CEO George Kurian. “No matter where customers are on their transformation journey, NetApp can help them build a data fabric to maximize the value of their data, ensure applications are running optimally, and unlock the best of cloud.” The new features and capabilities that NetApp introduced

omni:us Welcomes Insurance Veteran Antonio Derossi to Drive Growth Across US and Europe26.10.2020 18:00:00 EETPress release

omni:us, the insurance claims AI solution provider, welcomes Antonio Derossi as a member of the omni:us Senior Executive Advisory board. Mr. Derossi, with 20+ years of experience in various roles across insurance, consulting, and venture capital, will function as a key advisor on go-to-market and product optimization strategies for the North American and European insurance markets. omni:us seeks to fortify its position as global pioneer of insurance claims transformation with the expert support of Mr. Derossi. Both parties see automation as a defining element of future claims management systems. Mr. Derossi’s understanding of the intricacies of the American and European insurance space will support increased market penetration for the Berlin-based omni:us. He will also act as an effective liaison to insurance companies, solution providers and consulting partners across both continents. Derossi was born in Trieste, Italy. He holds a Laurea degree in physics from Trieste University, and

Dahua Sponsors Omdia Webinars on Next Generation Network Cameras26.10.2020 16:45:00 EETPress release

Dahua Technology, a world-leading video-centric smart IoT solution and service provider, has sponsored one white paper and two webinars hosted by Omdia. The theme of the webinars held on October 22nd is Solving security challenges: Next-generation network cameras. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201026005466/en/ (Photo: Business Wire) Omdia is the new global technology research powerhouse, established in 2019 with the combination of the Informa Tech’s research brands (Ovum, Heavy Reading, and Tractica) and the acquired IHS Markit technology research portfolio. Collaborating with Dahua Technology, the comprehensive webinar has attracted about 1200 registrations. Audiences are experts from various industries such as energy, finance, education, government, retail, etc. With webinar events experts from Omdia, Dahua Technology’s Senior Project Sales Manager Simon Nash and Omdia’s analysts Josh Woodhouse and Tommy Z

26th Yiwu Fair Concludes with Success, Reaching Deals Worth Millions in Small Commodities26.10.2020 16:36:00 EETPress release

The 26th China Yiwu International Commodities (Standards) Fair concluded in Yiwu on October 25, 2020. As the first large-scale foreign trade exhibition presented both online and offline in China amid regular epidemic prevention and control, Yiwu Fair 2020 provided more than 3,400 standard booths with an exhibition area of ​​100,000 square meters at the Yiwu International Expo Center, and attracted nearly 2,000 companies from 19 domestic provinces, municipalities and autonomous regions, covering categories of hardware, electromechanical facilities, electronic & electrical appliances, daily necessities, crafts & ornaments, stationery & office goods, toys, sporting & outdoor products, knitwear, and gift packaging. The Fair attracted a total of 106,000 offline visitors and 160 million online views. Seven overseas online matchmaking sessions were held targeting the United Kingdom, Malaysia, Chile, etc., and achieved an intended turnover of $4.66 million. While expanding the international ma

Interactive Brokers Launches Innovative Sustainable Investing Tool26.10.2020 16:18:00 EETPress release

Interactive Brokers Group (Nasdaq: IBKR), a global brokerage firm, today unveiled an innovative, interactive Impact Dashboard designed to help clients evaluate and invest in companies that align with their values. The dashboard, which is free for all clients to use, sets a new standard for tools that can be used for sustainable, socially responsible, and values-based investing. The launch comes as interest in Environmental, Social and Governance (ESG) investing is soaring. ESG assets are expected to top $53 trillion by 2022, according to research released in September by Celent. “The future of sustainable investing begins with the Impact Dashboard, which allows investors to align their portfolios with their values,” said Will Peterffy, ESG Director at Interactive Brokers. “In a world lacking transparency, the dashboard quickly analyzes and grades your stock portfolio based on your values and presents your holdings through a personalized ‘impact lens’. You can then decide whether to kee

In our pressroom you can read all our latest releases, find our press contacts, images, documents and other relevant information about us.

Visit our pressroom