Celltrion completes enrolment for global Phase II clinical trial with COVID-19 treatment candidate CT-P59
25.11.2020 14:13:00 EET | Business Wire | Press release
Celltrion Group today announced enrolment completion of 327 patients with mild-to-moderate symptoms of SARS-CoV-2 infection in the global Phase II clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. Celltrion anticipates submission for emergency use authorisation (EUA) to the Korean Ministry of Food and Drug Safety (MFDS), conditional on results from the global Phase II pivotal trial.
The global Phase II clinical trial is a randomised, double-blind, placebo-controlled and parallel-group trial designed to evaluate the efficacy and safety of CT-P59 in combination with standard of care in patients with SARS-CoV-2 infection. The trial enrolled 327 patients with mild-to-moderate symptoms of COVID-19 across three groups (placebo, low concentration, high concentration) and Celltrion is set to obtain the results for global Phase II trial. In addition, Celltrion plans to initiate a global Phase III clinical trial in more than 10 countries in order to obtain more comprehensive safety and efficacy results of CT-P59.
“We managed to successfully enrol 327 patients for the global Phase II trial and the results from the trial are expected in the coming weeks. We plan to compile a robust data set to support the planned emergency use application, expected as early as the end of the year, subject to positive study results,” said Dr. Sang Joon Lee, Senior Executive Vice President of Celltrion. “In order to respond to the global pandemic threat, we are moving forward with our clinical development with the highest urgency and as a key priority.”
In an effort to further address the pandemic, Celltrion has also initiated a post-exposure prophylaxis clinical trial to evaluate the preventive effect and safety of CT-P59 and identify whether this antibody treatment candidate can elicit a neutralising antibody response to prevent the virus from infecting human cells.
Celltrion is also working to increase its manufacturing capabilities to meet the current global and domestic demand for the anti-COVID-19 monoclonal antibody treatment candidate, ensuring potential delivery for as many as 2 million people per year globally.
- 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-191,2
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.
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.3
References
1 Coronavirus. World Health Organization. Available at: https://www.who.int/health-topics/coronavirus#tab=tab_1 Last accessed: November 2020
2 Coronaviruses. National Institute of Allergy and Infectious Diseases. Available at: https://www.niaid.nih.gov/diseases-conditions/coronaviruses Last accessed: November 2020
3 Celltrion. Data on file
To view this piece of content from cts.businesswire.com, please give your consent at the top of this page.
View source version on businesswire.com: https://www.businesswire.com/news/home/20201125005558/en/
Contact information
Sophia Eminson
seminson@hanovercomms.com
+44 (0) 7751 116252
Zuzanna Grzeskiewicz
zgrzeskiewicz@hanovercomms.com
+44 (0) 7506 339043
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
Compass Pathways Announces Exercise of $200 Million in Outstanding Warrants26.2.2026 13:30:00 EET | Press release
Compass Pathways plc (Nasdaq: CMPS), a biotechnology company dedicated to accelerating patient access to evidence-based innovation, announced today the exercise of 35,059,448 warrants, which were issued on January 13, 2025, for proceeds of approximately $200 million. Upon exercise of these outstanding warrants, Compass Pathways is issuing 15,160,619 American Depositary Shares (“ADSs”) and in lieu of ADSs, to certain institutional investors, pre-funded warrants to purchase up to 19,898,829 ADSs. Compass Pathways currently intends to use the proceeds from these warrant exercises, together with its existing cash and cash equivalents, to fund ongoing COMP005 and COMP006 Phase 3 trials, its Phase 2b/3 trial of COMP360 in PTSD, acceleration of its commercial readiness activities, and for working capital and general corporate purposes. The net proceeds from these warrant exercises, along with the net proceeds of approximately $141 million from the recent public offering that closed on Februar
BeOne Medicines Announces Fourth Quarter and Full Year 2025 Financial Results, Highlighting Global Success of BRUKINSA and Foundational Oncology Leadership26.2.2026 13:00:00 EET | Press release
BeOne Medicines Ltd. (NASDAQ: ONC; HKEX: 06160; SSE: 688235), a global oncology company, today announced financial results and corporate updates from the fourth quarter and full year 2025. “These strong financial results for the fourth quarter and full year 2025 underscore our continued evolution as a global oncology leader with durable competitive advantages in clinical development and manufacturing and one of the industry’s deepest and most differentiated pipelines,” said John V. Oyler, Co-Founder, Chairman and CEO at BeOne. “BRUKINSA has firmly established itself as the global leader in the BTK inhibitor class, distinguished by broad regulatory approvals, expanding geographic reach, strong physician adoption, and unmatched long-term efficacy and safety data in CLL. At the same time, we are securing new indications and expanded reimbursement for TEVIMBRA across key markets worldwide. With our late-stage, foundational hematology assets nearing commercialization and a robust solid tumo
Cyviz Unveils Containerized C2 Solution During HEIMDALL26.2.2026 12:00:00 EET | Press release
During Exercise HEIMDALL, organized by the Norwegian Joint Headquarters (FOH/NJHQ) this week, Cyviz is presenting its fully integrated, containerized solution for command, control, and collaboration environments. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20260226587573/en/ From deployment to operations: Cyviz’ container‑based C2 solution demonstrated during Exercise HEIMDALL. James Munt, Sales Director from Cyviz, took part in the demonstration. The solution is designed for secure, standardized, and agile operations, enabling operators to fight at the edge with assured information and supporting faster decision-making, in line with the company’s strategic focus on the defense and security sector. The container solution has been developed in collaboration with Nordic Shelter, providing the container platform. The modular platform combines control room technology, visualization, and software into one integrated system. It’s
ThreatAware Secures $25M from One Peak to Give Security Teams the Power to Build26.2.2026 12:00:00 EET | Press release
ThreatAware, the cyber asset management and cyber hygiene platform trusted by enterprises across sectors including retail, financial services, and energy, today announced it has raised $25 million in funding from One Peak, the growth equity firm specialising in high-growth software scale-ups. The investment will help ThreatAware scale its rapidly growing North American operations and accelerate its ambitious product roadmap, including the launch of ThreatAware's AI-powered security workspace. At the heart of ThreatAware's platform is its proprietary cyber asset management technology, which solves a problem most organisations don't even know they have. ThreatAware's data consistently reveals that, on average, 10% of devices accessing corporate networks go completely undetected by existing tools, while 30% of security controls are missing, misconfigured, or failing silently. As cloud adoption and remote working continue to expand the enterprise attack surface, these blind spots represent
Infobip is Set to Launch AgentOS to Orchestrate Autonomous AI-Driven Customer Journeys at Scale26.2.2026 11:00:00 EET | Press release
Global AI-first cloud communications platform Infobip, which celebrates its 20th anniversary this year, is set to launch its AI-native fully managed solution AgentOS. The new platform builds on Infobip's recently launched AI Agents, the intelligent foundation for autonomous customer communications. AgentOS is a major step in Infobip’s evolution from communications platform to intelligent orchestration layer for the AI era, enabling businesses to move from campaigns and workflows to autonomous, goal-driven interactions. AI communication models enable autonomous customer communications, hyper-personalization and highly engaging content across multiple channels. However, AI agents need a unified view of all customer touchpoints to deliver such benefits. Businesses must eliminate data silos. Yet readiness is low. Few enterprise AI agent projects reach production due to unstructured data and internal barriers. AgentOS overcomes these barriers, operationalizing AI safely and at scale across
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