Celltrion Initiates Post-exposure Prophylaxis Clinical Trial of an Anti-COVID-19 Monoclonal Antibody Treatment Candidate, CT-P59
Celltrion Group today announced the launch of its Phase III clinical trial investigating CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate as a preventative measure. The initiation of the post-exposure prophylaxis clinical trial follows the approval of the Investigational New Drug (IND) application by the Korean Ministry of Food and Drug Safety (MFDS) on October 8th, 2020.
Celltrion anticipates the enrolment of approximately 1,000 patients to evaluate population-based prophylaxis in contacts of SARS-CoV-2 infected patients. The post-exposure prophylaxis clinical trial will evaluate the preventive effect and safety of CT-P59 and whether CT-P59 can elicit a neutralising antibody response to prevent the virus from infecting human cells.
“We hope anti-COVID-19 monoclonal antibodies such as CT-P59 can provide high-risk individuals with effective protection against COVID-19 and help prevent further spread in the community,” said Dr Sang Joon Lee, Senior Executive Vice President of Celltrion. “We look forward to continued data generation as this trial proceeds and we remain committed to combatting the spread of the virus around the world.”
Celltrion has previously shown promising safety results in the Phase I clinical trial in healthy volunteers. The MFDS has now approved Celltrion’s IND application to initiate a Phase II/III pivotal trial of this potential treatment in mild-to-moderate patients.
- 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
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: October 2020
2 Coronaviruses. National Institute of Allergy and Infectious Diseases. Available at: https://www.niaid.nih.gov/diseases-conditions/coronaviruses Last accessed: October 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/20201012005555/en/
Contact information
Preetika Ramjoorawon
pramjoorawon@hanovercomms.com
+44 (0) 20 3817 6766
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
BitGo Secures OCC Approval to Convert to Federally Chartered National Trust Bank13.12.2025 03:10:00 EET | Press release
BitGo Holdings, Inc. (“BitGo”), the digital asset infrastructure company, today announced that the Office of the Comptroller of the Currency (“OCC”) approved its application to convert BitGo Trust Company, Inc., a South Dakota-chartered trust company, to a national bank named BitGo Bank & Trust, National Association (N.A.). With today’s OCC approval of its conversion, BitGo’s Trust Company subsidiary is now operating as BitGo Bank & Trust, National Association (N.A.). BitGo Bank & Trust, N.A. will operate under a single, uniform federal supervisory regime, enabling it to deliver the clarity, governance, and regulatory certainty institutions expect from a federally regulated fiduciary. This approval reinforces BitGo’s position as an institutional foundation for the modern financial system, combining bank-level oversight with the security, compliance, and scalability that define BitGo’s infrastructure. Under the national bank charter, and subject to applicable law and OCC requirements, B
FIA, Formula 1 Group and All 11 Race Teams Officially Sign the Ninth Concorde Agreement, Securing Strength and Stability for the Sport in Pivotal Five-Year Agreement12.12.2025 18:10:00 EET | Press release
The Fédération Internationale de l'Automobile (FIA), the global governing body for motor sport and the federation for mobility organisations worldwide, and Formula 1 Group, the Commercial Rights Holder, have today announced the signing of the Concorde Governance Agreement, a crucial contract defining the regulatory framework and governance terms of the FIA Formula One World Championship until 2030. This follows the announcement in March that the 2026 Commercial Concorde Agreement had been signed by all the teams and Formula 1 Group. Together, these agreements constitute the ninth Concorde Agreement, representing a major step forward in the professionalisation and global development of the sport. First introduced in 1981, the Concorde Agreements are designed to promote sporting fairness, technological innovation and operational excellence, and align all key stakeholders around a shared vision for structured governance and continued growth of the sport. Each iteration of the Concorde Agr
Anabranch Capital Management, LP supports relisting of SmartCraft ASA to Nasdaq Stockholm12.12.2025 17:26:00 EET | Press release
Reference is made to the stock exchange announcement by SmartCraft ASA ("SmartCraft" or the "Company") on 1 December 2025 regarding the contemplated relisting of SmartCraft from Euronext Oslo Børs to Nasdaq Stockholm (the "Relisting") and the announcement of a cross-border merger to effect the Relisting. Funds managed by Anabranch Capital Management, LP (“Anabranch”) intend to vote in favour of the merger plan resolved by the boards of SmartCraft and its Swedish wholly owned subsidiary, SmartCraft Group AB (publ), to effect the Relisting at the Company's extraordinary general meeting planned for January 2025 (the "EGM"). Anabranch intends to vote with all Anabranch shares held at the Record Date for the EGM in favour of the relisting effected by the merger plan. Funds managed by Anabranch currently hold approximately 15.9 million shares in SmartCraft. Disclaimer: The views expressed are those of the authors and Anabranch Capital Management, LP as of the date referenced and are subject
Mohammed Ben Sulayem Re-Elected as President of the FIA12.12.2025 16:49:00 EET | Press release
The Fédération Internationale de l’Automobile (FIA), the global governing body for motor sport and the federation for mobility organisations worldwide, today confirms that Mohammed Ben Sulayem has been re-elected as President of the FIA, following the election of his Presidential List by the General Assembly in Tashkent, Republic of Uzbekistan. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251212213181/en/ President Mohammed Ben Sulayem now begins his second four-year term, having overseen a period of significant renewal and stabilisation for the organisation since his initial election in 2021. Over the past four years, the FIA has undergone a wide-ranging transformation, improving governance, operations and restoring the financial health of the federation. These changes have strengthened the FIA’s position as the world’s governing body for motorsport and the leading authority on safe, sustainable, and affordable mobility.
Capcom’s All-new IP PRAGMATA to Launch on April 24, 2026!12.12.2025 16:00:00 EET | Press release
Capcom Co., Ltd. (TOKYO:9697) today announced that sci-fi action-adventure game PRAGMATA, a completely new IP, is scheduled for release on April 24, 2026. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20251212791950/en/ PRAGMATA Key Art PRAGMATA is a new type of sci-fi action-adventure game mixing puzzle and action elements. In the game, which takes place on the moon in a near-future world, the spacesuit-clad Hugh and android girl Diana cooperate while fighting their way back to Earth. By bringing the title to Nintendo Switch™ 2 in addition to PlayStation®5 system, Xbox Series X|S and PC, Capcom looks to further advance its multi-platform strategy and expand its user base. Moreover, a playable demo of the game will be released first on PC starting today, December 12, to further convey the appeal of the title. The company hopes that players look forward to PRAGMATA, which has already garnered acclaim for its playable demos at
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