Celltrion Group announces positive top-line efficacy and safety data from global Phase II/III clinical trial of COVID-19 treatment candidate CT-P59
Celltrion Group today announced top-line results from its randomised, double-blind, and placebo controlled global Phase II/III clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. The Part I of the trial enrolled 327 patients with mild-to-moderate symptoms of COVID-19 across three treatment groups (40mg/kg, 80mg/kg and placebo), in which approximately 60% of patients with moderate symptoms suffered from COVID-19 related pneumonia.
This data analysis has demonstrated that at Day 28, CT-P59 treated patients presented with a significantly reduced risk of COVID-19 related hospitalisation and oxygenation without mortality. When compared to placebo, CT-P59 (40mg/kg) treated patients reported reduced progression rates to severe COVID-19 by 54% for mild-to-moderatepatients and 68% for moderate patients aged 50 years and over.
CT-P59 treatment groups also reported with significantly shortened time to clinical recovery ranging from 3.4 to 6.4 days quicker compared to placebo. Patients treated with CT-P59 (40mg/kg) recovered 3.4 days earlier than those in the placebo group [5.4 vs. 8.8 days; 95% C.I, 5.35(3.97, 6.78) to 8.77 (6.72, 11.73), log-rank p-value= 0.0097]. Patients with pneumonia treated with CT-P59 (40mg/kg) reported shortened recovery time by 5.1 days compared to placebo [5.7 vs. 10.8 days; 95% C.I, 5.73 (4.13, 7.33) to 10.81 (6.81, N.C.)]. Moderate patients aged 50 years and over treated with CT-P59 (40mg/kg) reported a shortened recovery time by 6.4 days compared to placebo [6.6 vs. 13.0 days; 95% C.I, 6.64 (4.13, 11.94) to 12.97 (6.81, N.C.)].
In addition, CT-P59 treated patients rapidly and significantly reduced viral load through Day 7 compared to placebo. Top-line results from the trial shows CT-P59 to have a positive safety profile, comparable to that of the placebo group, with no serious adverse advents reported. Infusion related reactions were mild and transient, with the CT-P59 treatment group having reported 0.5%, compared to 1.8% reported with placebo.
“The data demonstrate that CT-P59 could contribute to both a reduced time to clinical recovery, as well as a reduced proportion of patients who progress to severe disease.” said Professor Joong-Sik Eom, Infectious Disease Division at Gil Medical Center of Gachon University, “The treatment’s safety profile was comparable to that of placebo and generally well-tolerated. Therefore, it is anticipated that CT-P59 would positively contribute to the management and control of the current COVID-19 pandemic across the world.”
Nature Communications has published the preclinical data of CT-P59 against SARS-CoV-2, demonstrating a 100-fold reduction in the viral load of SARS-CoV-2 and improved recovery time in animal models. Additionally, the data showed encouraging results meeting several criteria from its studies; in-vitro plaque reduction neutralization test (PRNT) against SARS-CoV-2 and SARS-CoV-2 D614G variant to assess the neutralization potency of CT-P59, in-vivo efficacy in animal models to demonstrate in vivo antiviral efficacy of CT-P59, as well as in vitro antibody-dependent enhancement (ADE) assay to investigate the possible adverse effects of a COVID-19 treatment.1
“Our top-line data from the global Phase II/III clinical trial have demonstrated that CT-P59 is effective for the treatment of COVID-19 in mild-to-moderate patients and especially in moderate patients aged 50 years and over. We are encouraged by the robust and consistent nature of the top-line clinical profile of CT-P59 and our clinical studies are on track in more than 10 countries.” said Dr. HoUng Kim, Ph.D., Head of Medical and Marketing Division at Celltrion Healthcare. “We are planning to manufacture doses for around two million patients in 2021 and hope to improve access to this treatment option for those that require.”
- 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 CT-P59 (Regdanvimab)
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. Results from the global Phase I clinical trial of CT-P59 demonstrated promising safety, tolerability, antiviral effect and efficacy profile in patients with mild symptoms of COVID-19.2
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.
1 Kim, C., Ryu, DK., Lee, J. et al. A therapeutic neutralizing antibody targeting receptor binding domain of SARS-CoV-2 spike protein. Nat Commun 12, 288 (2021). https://doi.org/10.1038/s41467-020-20602-5 [Last accessed January 2021
2 Celltrion Data on file
About 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
Kyoto Semiconductor Signs Supply and Reseller Agreement With CEL13.4.2021 03:00:00 CEST | Press release
Kyoto Semiconductor Co., Ltd., a leading optical device solution manufacturer with world-class technologies and Japanese quality, has announced that it has entered into an agreement with California Eastern Laboratories (CEL) to be a multinational reseller of Kyoto Semiconductor’s optical device solutions. The partnership extends Kyoto Semiconductor’s sales and support network not only to North America but to countries such as India and Israel while it enhances CEL’s product offering with Kyoto Semiconductor’s high-quality photodiodes for optical communication and sensing equipment “Kyoto Semiconductor is pleased to collaborate with CEL, one of the best suppliers of compound and silicon semiconductors, known for its superior customer support and technological expertise. With this partnership, we extend our customer reach worldwide, ranging from North America to India or Israel”, said Tsuneo Takahashi, CEO at Kyoto Semiconductor. “Our products are critical for the 5G and beyond-5G wirele
Bentley Systems Brings Infrastructure Digital Twins to NVIDIA Omniverse12.4.2021 19:00:00 CEST | Press release
GTC21 – Bentley Systems, Incorporated (Nasdaq: BSY), the infrastructure engineering software company, today announced that it is developing applications using the NVIDIA Omniverse platform for photorealistic, real-time visualization and simulation of digital twins of massive-scale industrial and civil infrastructure projects. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210412005214/en/ Image courtesy of Houston Waterworks Team (a Joint Venture of Jacobs Engineering Group, Inc. and CDM Constructors, Inc.) Bentley Systems has extended the Bentley iTwin platform to integrate with NVIDIA Omniverse to provide a graphics pipeline for AI-enhanced, real-time visualization, and simulation of infrastructure digital twins. This integration allows engineering-grade, millimeter-accurate digital content to be visualized with photorealistic lighting and environmental effects on multiple devices including web browsers, workstations, tabl
QCT Unveils Optimized Accelerated Server to Boost High-Performance Workloads12.4.2021 19:00:00 CEST | Press release
Quanta Cloud Technology (QCT), a global data center solution provider, today announced a new addition to its broad portfolio of NVIDIA-Certified SystemsTM with its QuantaGrid D43N-3U. This server complements QCT’s existing high-performance QuantaGrid and QuantaPlex family of servers, while enabling customers the ability to leverage the latest next-generation NVIDIA Tensor Core GPUs for advanced AI workloads, including those that run on virtualized infrastructure with the NVIDIA AI Enterprise software suite. NVIDIA Tensor Core GPUs on QCT systems are built on the rich ecosystem of AI frameworks from the NVIDIA NGC catalog, CUDA-X libraries, over 2.3 million developers, and over 1,800 GPU-optimized applications to help enterprises solve the most critical challenges in their business. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210412005024/en/ QuantaGrid_D43N-3U (Photo: Business Wire) “Utilizing NVIDIA accelerated computing
Mavenir Launches 5G Hyperconverged Edge AI Solution for Enterprise & Telco Market Based on NVIDIA Platforms12.4.2021 19:00:00 CEST | Press release
Mavenir, the industry’s only end-to-end cloud-native Network Software Provider and a leader in accelerating software network transformation for communications service providers (CSPs), announced today the launch of an AI-on-5G Hyper Converged Edge solution working in close collaboration with NVIDIA. Mavenir has developed this unique solution, based on NVIDIA’s hardware and software technologies, enabling Enterprises & Telcos to implement AI-on-5G applications for many promising verticals such as Manufacturing, Mining, and Healthcare that cover Industry 4.0 applications, including Industrial Internet of Things (IIoT), Intelligent Video Analytics (IVA) and Extended Reality (XR) and Gaming use cases. The use cases can be around remote and immersive collaboration, precision robotics control, people safety, intrusion detection, smart connected factories, real-time manufacturing component defect detection and proactive maintenance using near real-time analytics of sensor data. 5G enables an
Merck Advances ATR Inhibitor Berzosertib in Small Cell Lung Cancer With New Published Data and Initiation of Phase II Trial With Registrational Intent12.4.2021 17:04:00 CEST | Press release
Merck, a leading science and technology company, today announced key clinical advancements for berzosertib (M6620), an investigational, potent and selective ataxia telangiectasia and Rad3-related (ATR) inhibitor. Berzosertib is the leading asset in the company’s DNA damage response (DDR) inhibitor program and one of the most advanced ATR inhibitors in oncology clinical development industry-wide. Results from a Phase II proof-of-concept study conducted by the US National Cancer Institute (NCI) (NCT02487095)* and published in Cancer Cell showed that berzosertib in combination with the chemotherapy topotecan resulted in an objective response rate (ORR) of 36% among patients with relapsed small cell lung cancer (SCLC), including durable responses among a majority of responding patients with platinum-resistant disease.1 The NCI is also conducting a separate Phase II trial of berzosertib in combination with topotecan versus topotecan monotherapy in SCLC that has relapsed (NCT03896503)* which
Loomis Sayles Welcomes Susan Sieker as Chief Financial Officer12.4.2021 16:15:00 CEST | Press release
Loomis, Sayles & Company, an affiliate of Natixis Investment Managers, announced today that Susan Sieker has joined Loomis Sayles as executive vice president and chief financial officer (CFO). She also joins the Loomis Sayles Board of Directors. Susan reports to Kevin Charleston, chairman and chief executive officer of Loomis Sayles, and will oversee the finance organization. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20210412005613/en/ Susan joins Loomis Sayles from Cambridge Associates, where she was the chief financial officer and oversaw financial planning and analysis, treasury, accounting operations, financial reporting, payroll and taxes. Prior to joining Cambridge Associates in 2012, Susan served in a variety of finance and risk leadership roles at Brinker International, including vice president and treasurer, vice president of global infrastructure, vice president of benefits, vice president of business assurance
Alira Health Strengthens Its Growth Strategy With a $35M Funding, Led by Creadev12.4.2021 15:00:00 CEST | Press release
Alira Health (www.alirahealth.com), a leading international advisory firm dedicated to advancing healthcare and life sciences, announced it has closed a $35M equity financing led by Creadev, an evergreen investment company backed by the Mulliez family. This new partnership will help accelerate the firm’s growth strategy, focused on merging pharmaceutical, medical and digital technologies development with medical care through a patient-centric approach. “I would like to thank our team of investors for joining our mission to enable healthcare transformation. Their investment positions us to change the way life sciences advisory services are delivered,” said Gabriele Brambilla, Chief Executive Officer and Co-Founder of Alira Health. “We are building a powerful continuum of services that spans the product and solutions development life cycle, supported by the recent additions of our patient engagement, real-world evidence and advanced analytics practices. This financing allows us to advanc
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