Business Wire

Celltrion announces positive top-line results from global Phase III trial of regdanvimab (CT-P59), an anti-COVID-19 monoclonal antibody treatment

Share

Celltrion Group today announced top-line efficacy and safety data from the global Phase III clinical trial, demonstrating that anti-COVID-19 monoclonal antibody treatment candidate, regdanvimab (CT-P59), met all primary and key secondary endpoints in patients with mild- to- moderate symptoms of COVID-19 (n=1,315). Results showed that CT-P59 significantly reduced the risk of hospitalisation or death by 72% for patients at high- risk of progressing to severe COVID-19 up to Day 28, compared to placebo, meeting the primary efficacy endpoint [3.1 vs. 11.1 %, p-value< 0.0001]. CT-P59 also significantly reduced the risk of hospitalisation or death by 70% in all patients, meeting the first key secondary endpoint [2.4 vs. 8.0 %, p-value< 0.0001].

The trial also met the other key secondary endpoints, including faster and persistent reduction in symptom duration. Patients treated with CT-P59 (40mg/kg) recovered at least 4.7 days earlier than those in the placebo-treated patients [median 9.3 vs. minimum 14 days, p-value< 0.0001] for patients at high- risk of progressing to severe COVID-19. For all patients treated with CT-P59 (40mg/kg), patients recovered 4.9 days earlier than those in the placebo-treated patients [median 8.4 vs. 13.3 days, p-value< 0.0001].

Top-line results also showed CT-P59 to have a positive safety profile, with no clinically meaningful differences between patients treated with CT-P59 (40mg/kg) and placebo-treated patients. Infusion related reactions were mild and transient, with most patients recovering within 1~3 days.

“We continue to be challenged by the COVID-19 pandemic and new variants of concern,” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “As many hospitals across the globe now exceed their ability to accommodate patients due to COVID-19, it is critical that we use every resource to reduce the burden on the healthcare system. This well-controlled trial provides conclusive results demonstrating that CT-P59 can improve outcomes in people with mild- to- moderate COVID-19 and also significantly reduce the risk of hospitalisation and death. We look forward to continuing to work with regulators around the world to make CT-P59 available to more patients in need.”

Therapeutic effect of CT-P59 against B.1.351 variant (first identified in South Africa, now classified by the WHO as Beta) was updated through the publication from Biochemical and Biophysical Research Communications. According to the article, in vivo ferret challenge studies demonstrated that a therapeutic dosage of CT-P59 was able to decrease B.1.351 viral load in the upper and lower respiratory tracts, comparable to that observed for the wild type virus.1

Celltrion plans to release full Phase III data in the coming months and plans to present the data at an oral session at the 31st European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), which will take place online from 9 -12 July 2021.

-ENDS -

Notes to Editors:

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 110 different countries. For more information please visit: https://www.celltrionhealthcare.com/en-us.

About regdanvimab (CT-P59) and clinical trials

CT-P59 was identified as a potential treatment for COVID-19 through screening of antibody candidates and selecting those that showed the highest potency in neutralising the SARS-CoV-2 virus. In vitro and in vivo pre-clinical studies showed that CT-P59 strongly binds to SARS-CoV-2 RBD and significantly neutralise the wild type and mutant variants of concern including the Alpha UK variant (B.1.17). In in vivo models, CT-P59 effectively reduced the viral load of SARS-CoV-2 and inflammation in lung. Results from the global Phase I and II clinical trials of CT-P59 demonstrated a promising safety, tolerability, antiviral effect and efficacy profile in patients with mild- to- moderate symptoms of COVID-19.2 Celltrion also has recently commenced the development of a neutralising antibody cocktail with CT-P59 against new emerging variants of SARS-CoV-2. The research for Celltrion’s clinical trials was supported by a grant as part of the Korea Health Technology R&D Project from the Korea Health Industry Development Institute (KHIDI), funded by the ministry of Health & Welfare, Republic of Korea (grant number: HQ2xC00xx).

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 Ryu DK., et al. Therapeutic effect of CT-P59 against SARS-CoV-2 South African variant. Biochemical and Biophysical Research Communications, Volume 566, 2021, Pages 135-140, https://doi.org/10.1016/j.bbrc.2021.06.016. [Last accessed June 2021]

2 Celltrion Data on file

To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.

Contact information

Holly Barber
hbarber@hanovercomms.com
+44 (0) 7759 301620

Donna Curran
dcurran@hanovercomms.com
+44 (0) 7984 550312

About Business Wire

Business Wire
Business Wire



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

Prosus FAQ's Regarding the Voluntary Share Exchange Offer to the Holders of Naspers N Ordinary Shares30.7.2021 19:00:00 CEST | Press release

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, DIRECTLY OR INDIRECTLY, IN OR INTO ANY JURISDICTION IN WHICH SUCH RELEASE, PUBLICATION OR DISTRIBUTION WOULD BE PROHIBITED BY APPLICABLE LAW. PLEASE SEE THE IMPORTANT DISCLAIMERS AT THE END OF THIS ANNOUNCEMENT. Shareholders are referred to the prospectus (Prospectus) published by Prosus N.V. (Prosus) on 12 July 2021 in respect of the voluntary share exchange offer by Prosus to Naspers (JSE:NPN) (LSE:NPSN) N Shareholders (Exchange Offer). Further to the announcement issued by Prosus today, shareholders are advised that since the publication of the Prospectus Prosus has received certain frequently asked questions regarding the Exchange Offer and has therefore made certain materials available today at www.share-exchange-offer.com, where these frequently asked questions have been addressed by Prosus. Cape Town South Africa 30 July 2021 About Naspers Established in 1915, Naspers has transformed itself to become a global consumer internet compan

Prosus FAQ's Regarding the Voluntary Share Exchange Offer to the Holders of Naspers N Ordinary Shares30.7.2021 18:59:00 CEST | Press release

Shareholders are referred to the prospectus (Prospectus) published by Prosus on 12 July 2021 in respect of the voluntary share exchange offer by Prosus to Naspers N Shareholders (Exchange Offer). Since the publication of the Prospectus Prosus has received certain frequently asked questions regarding the Exchange Offer and has therefore made certain materials available today at www.share-exchange-offer.com, where these frequently asked questions have been addressed. About Prosus Prosus is a global consumer internet group and one of the largest technology investors in the world. Operating and investing globally in markets with long-term growth potential, Prosus builds leading consumer internet companies that empower people and enrich communities. The group is focused on building meaningful businesses in the online classifieds, food delivery, payments and fintech, and education technology sectors in markets including India, Russia, and Brazil. Through its ventures team, Prosus invests in

I’mbesideyou Inc. Launched “UNION OF EMOTIONS” Service Using AI to Visualize Cheering Each Other Across National Borders30.7.2021 16:25:00 CEST | Press release

I’mbesideyou Inc. (Setagaya-ku, Tokyo CEO: Shozo Kamiya, hereinafter referred to as I'mbesideyou) launched the "UNION OF EMOTIONS" service on July 23, 2021, the opening day of an international sporting event. This is the first time we have been able to visualize people cheering each other with emotion analysis AI. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210730005404/en/ A visualization of the emotions of cheers flying around the world: Click on each cheer to learn more about that country. (Photo: Business Wire) More than 20,000 cheers have already been sent from more than 79 cities across more than 14 countries around the world, and the sight of the cheers flying across the globe has moved many people on social media. UNION OF EMOTIONS, is the world's first example of people's emotions connecting in real time across countries with the help of AI. It is scheduled to be available until August 8, when the closing ceremon

Palace Bidco Oy (“WSIP Bidco”) Has Received Necessary Regulatory Approval Concerning the Recommended Cash Offer to the Shareholders of Adapteo Plc (“Adapteo”)30.7.2021 14:23:00 CEST | Press release

This announcement is not an offer, whether directly or indirectly, in Australia, Canada, Hong Kong, Japan, New Zealand or South Africa or in any other jurisdiction where such offer pursuant to legislation and regulations in such relevant jurisdiction would be prohibited by applicable law. Shareholders not resident in Sweden or Finland who wish to accept the Offer (as defined below) must make inquiries concerning applicable legislation and possible tax consequences. Shareholders should refer to the offer restrictions included in the section titled “Important information” at the end of this announcement and in the offer document which was published on 23 June 2021. Shareholders in the United States should also refer to the section titled “Special notice to shareholders in the United States” at the end of this announcement and in the offer document. On 17 May 2021, WSIP Bidco, a private limited liability company formed on behalf of, and indirectly wholly owned by, West Street Global Infra

Taipei Exchange Launches Pioneer Stock Board to Support Innovative Enterprises30.7.2021 10:00:00 CEST | Press release

The Taipei Exchange, TPEx, launched Pioneer Stock Board (PSB) on July 20, 2021, which welcomed its first company on July 26. Pioneer Stock Board marks the evolution of the stock market into an innovation-friendly ecosystem. It aims to facilitate entry to capital markets for more innovative enterprises. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210730005008/en/ Taipei Exchange launches Pioneer Stock Board to support innovative enterprises (Photo: Business Wire) At the PSB Launch Ceremony, Premier Su Tseng-chang delivered the opening speech, emphasizing the government’s support. Su said, “Taiwan’s capital market breaks new ground today, by establishing this board. PSB will support innovative enterprises, a key driver of economic transformation, by providing companies with quick access to capital needed for continued growth.” Dr. Tien-mu Huang, Chairperson of Financial Supervisory Commission, remarked, “Innovation underpin

ITRS Group Continues Expansion With the Acquisition Of Opsview30.7.2021 10:00:00 CEST | Press release

ITRS Group, a leading provider of real-time monitoring and analytics software, has acquired 100% of Opsview Limited, a modern, scalable monitoring platform, which provides unified insight into dynamic IT operations on-premises, in the Cloud or hybrid. Opsview will remain and operate as a separate brand and entity. The purchase of Opsview aligns well with ITRS’ strategy to build, buy and partner to deliver smart, automated and predictive end-to-end monitoring solutions for increasingly complex IT estates across industries. This development follows the successful strategic acquisitions of Sumerian, OP5 and Uptrends. Guy Warren, CEO of ITRS commented: “Opsview is trusted by hundreds of businesses, government organisations and service providers globally. This acquisition will enhance our technological innovation, increase our portfolio capability, and provide continued expansion across our global support services.” Mike Walton, CEO and founder of Opsview said: “Partnering with ITRS represe

Schneider Electric Moves Forward With Its Sustainability Impact Targets, Mobilizing Support From Employees, Partners and Customers30.7.2021 08:32:00 CEST | Press release

Schneider Electric, the leader in the digital transformation of energy management and automation, published today its half-year progress overview on setting up and advancing on its 2021-2025 sustainability impact targets. Schneider Electric, named as the world’s most sustainable corporation 2021 by the Corporate Knights Global 100 Index, announced the acceleration of its sustainability strategy in January, aligned to its commitments regarding climate, resources, trust, equal opportunities, generations, and local communities. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210729006295/en/ Schneider Sustainability Impact - H1 Results (Graphic: Business Wire) Since then, the Group has successfully launched The Zero Carbon Project, its initiative to halve carbon emissions of its top supply chain partners by 2025, a call to action already joined by 91% of them. By engaging, training, and supporting the sustainable transformation

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