Business Wire

Celltrion receives MHRA approval to initiate Phase I trial of potential COVID-19 antiviral antibody treatment, CT-P59, in the UK

Share

Celltrion Group announced that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has approved the company’s Clinical Trial Authorisation (CTA) application for a Phase I clinical trial with CT-P59, a COVID-19 antiviral antibody treatment candidate, in patients with mild symptoms of SARS-CoV-2 infection. The clinical trial is set to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of CT-P59.

Celltrion plans to conduct further global Phase II/III trials in patients with mild and moderate COVID-19 and anticipates results from these pivotal studies by the end of the year. Furthermore, a clinical trial investigating the use of CT-P59 as a preventative measure, by enrolling people in close contact with COVID-19 patients globally, is also planned and the topline data for this trial are anticipated in Q1 of 2021.

Celltrion will start the full-scale commercial production of CT-P59 in September this year and is securing sufficient manufacturing capacity to produce enough of the potential COVID-19 treatment for up to 5 million patients a year.

“This is a timely approval from the UK regulatory authority for the Phase I clinical trial with CT-P59 as the global pandemic continues to grow and there remains a significant need for a safe and effective treatment for COVID-19,” said Dr. Sang Joon Lee, Senior Executive Vice President of Celltrion. “We are rapidly advancing our COVID-19 programme with CT-P59, including a Phase I clinical trial in healthy volunteers in Korea. Furthermore, we are making efforts to ensure that if the clinical trial programme is successful we are able to scale up manufacturing appropriately.”

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 including the mutated G-variant strain (D614G variant). In pre-clinical data the treatment candidate demonstrated a 100-fold reduction in viral load of SARS-CoV-2, as well as a reduction in lung inflammation.1

- 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 COVID-192,3
Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases. Novel coronavirus SARS-CoV-2 is responsible for the disease COVID-19, this new strain, discovered in 2019, is behind the ongoing pandemic outbreak.

The most common signs of COVID-19 include fever, dry cough and tiredness; however, people may also experience other symptoms including shortness of breath and breathing difficulties. Most people infected with the virus will exhibit mild to moderate symptoms however older people, and those with existing underlying conditions such as cardiovascular disease and diabetes are more likely to develop a more severe form of COVID-19.

Please find up to date information about the outbreak via the World Health Organization at https://www.who.int/health-topics/coronavirus#tab=tab_1

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 Celltrion. Data on file

2 Coronavirus. World Health Organization. Available at: https://www.who.int/health-topics/coronavirus#tab=tab_1 Last accessed: July 2020

3 Coronaviruses. National Institute of Allergy and Infectious Diseases. Available at: https://www.niaid.nih.gov/diseases-conditions/coronaviruses Last accessed: July 2020

Contact information

Zuzanna Grzeskiewicz
zgrzeskiewicz@hanovercomms.com
+44 (0) 7506 339043

Sophia Eminson
seminson@hanovercomms.com
+44 (0) 7751 116252

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

BAT Highlights Serious Inaccuracies in EU e-Cigarette Review29.10.2020 10:56:00 CETPress release

BAT has called on a European Commission scientific committee to enhance the quality of its ongoing review into e-cigarettes. BAT highlighted several serious flaws, the details of which it makes public today. The results of the review may pave the way for revisions to rules that affect millions of vapers across the EU. The SCHEER Committee (Scientific Committee on Health, Environmental and Emerging Risks) is an advisory body that was tasked with producing a scientific review of the health effects of e-cigarettes as part of the European Commission’s forthcoming review of the Tobacco Products Directive. The consultation period for this review has now closed. BAT’s response highlights major flaws with the methodology and conclusions of the review including that it: Fails to contextualize the risks of e-cigarettes relative to those associated with continued smoking. Makes inaccurate claims regarding e-cigarettes many of which have been widely debunked by the scientific and public health com

Icon Solutions Secures Strategic Investment From J.P. Morgan29.10.2020 10:15:00 CETPress release

Icon Solutions, the specialist provider of world-class payment solutions and consultancy services, today announced a strategic investment from J.P. Morgan. Icon Solutions is a leading global provider of payments technology and expertise, with a proven track record developing, implementing and running innovative, mission critical transaction banking solutions. Icon has also defined, architected and built IPF: a cloud native, highly cost-effective and collaborative payments platform that combines open source technology with light-weight integration. “We’re excited to support Icon with this strategic investment as they look to continually build a simplified, collaborative payments ecosystem, driving emerging payments rails and innovation,” said Sara Castelhano, EMEA Head of Payments, Digital and Solutions, J.P. Morgan Wholesale Payments. Icon will invest in its technology and geographic reach, helping new and existing customers do more with less and realise the potential of payments in th

Airship Journeys Powers Massive Conversion Gains for Brands Across the Globe29.10.2020 09:30:00 CETPress release

Customer engagement company Airship today detailed the amazing success three brand marketers have achieved using Airship Journeys to more quickly and easily improve the business impact of cross-channel customer journeys. The customer journeys these marketers have optimized have driven double- and even triple-digit percentage performance improvements over baselines established by control groups. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201029005340/en/ Airship Journeys enables an at-a-glance understanding of how cross-channel journeys are performing against business goals, trending performance lifts against control group baselines to direct optimization efforts and maximize business value. (Graphic: Business Wire) Airship Journeys combines everything marketers need to create, evaluate, test and optimize cross-channel customer engagement journeys in a single, intuitive visual UI. Only Airship Journeys allows marketers to

Realtek Semiconductor Selects Allegro DVT’s H.266/VVC Compliance Streams29.10.2020 08:57:00 CETPress release

Allegro DVT, the leading provider of video codec compliance test suites and semiconductor video IPs, today announced that Realtek Semiconductor, one of the world's largest and most successful fabless semiconductor companies, has selected Allegro DVT’s VVC test streams and will be used to ensure compliance of Realtek’s products with the new emerging VVC video compression standard. Versatile Video Coding (VVC) is the latest video compression standard that was finalized in June 2020. The VVC codec has been conceived to be versatile and to address all video applications such as mobile telephony, VOD, Broadcasting, OTT streaming, videoconferencing, screen content, 360° and scalable coding and their requirements in terms of resolution, bitrates and latency. The Allegro DVT VVC test suite enables comprehensive coverage and verification of VVC decoders and ensures that decoders are fully compliant with all corner cases of the VVC specification. Furthermore, this VVC test suite is part of a bro

SES and CANAL+ Strengthen Partnership With Long-Term Extensions across Western Europe, Central Europe and Africa29.10.2020 08:50:00 CETPress release

SES and CANAL+ have signed new long-term strategic agreements for satellite capacity across three geographies, strengthening the companies’ longstanding partnership and underlining the importance of satellite in delivering premium content to more than 10 million subscribers. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201029005375/en/ SES and CANAL+ Strengthen Partnership With Long-Term Extensions across Western Europe, Central Europe and Africa (Photo: Business Wire) The multi-transponder contract renewal extends SES and CANAL+ relationship to the end of the decade. It enables SES to support the French pay-TV operator in broadcasting its high-quality bouquets to millions of households around the world via 19.2 degrees East, 23.5 degrees East and 22 degrees West. The new contract represents additional secured backlog of over EUR 230 million and includes options for additional capacity and extensions. Partners with SES sin

Thales Launches Its Identity Verification Suite, a Secure Biometric Solution for Customer Onboarding29.10.2020 08:00:00 CETPress release

Thales, world leader in digital security, has launched its Identity Verification Suite, in response to the rising need of remote client onboarding. With privacy and user experience as its heart, the IDV Suite enables a secure and 100%-AI identity verification service. It integrates the latest facial recognition technology, document security features recognition and machine learning engines. The solution addresses the Covid-19 environment with touchless interactions, allowing service providers to reach end users via their mobile handsets or the web. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20201029005392/en/ (Photo: Thales) Secure identity verification has become a crucial part of online security and digital onboarding, and constitutes a significant opportunity for businesses. In cases such as digital enrolment or KYC (Know Your Customer) regulations, ID verification is critical in order to efficiently detect fraud and th

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