Celltrion Group announced that the Korean Ministry of Food and Drug Safety (MFDS) has approved the Investigational New Drug (IND) application from the company for the Phase I clinical trial with CT-P59, which is an antiviral treatment candidate with antibodies to COVID-19. Celltrion has begun the enrollment of patients with mild symptoms of SARS-CoV-2 infection and the clinical trial has been developed to assess the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of CT -P59.

By the end of the year, Celltrion expects the results of the pivotal global study from Phase II and III trials in patients with mild symptoms, from the Phase III clinical trial in patients with moderate to moderate COVID-19 symptoms. severe and prevention clinical trial. Celltrion plans to incorporate those who have close contact with COVID-19 patients and those who have no symptoms as part of a prevention clinical trial to assess whether CT-P59 can elicit a neutralizing antibody response to prevent the virus from infecting cells. human.

“ We have initiated a Phase I clinical trial with CT-P59 in humans in patients with mild symptoms of COVID-19 and we plan to conduct more Phase II and III trials globally in this group of patients. In addition, Celltrion plans to combine Phase II and III trials in patients who have moderate to severe symptoms of COVID-19 through prevention clinical trials, ”said Dr. Sang Joon Lee, Senior Executive Vice President of Celltrion. " We are very encouraged by the steady progress we are making in preparing for our clinical trials with CT-P59 in various settings and will continue to race to reach our next milestones."

In July, Celltrion started a Phase I trial with CT-P59 in the UK following approval of the application for Clinical Trial Authorization (CTA) by the UK Medicines and Healthcare Products Regulatory Agency (MHRA). Celltrion has also completed an infusion and initial safety assessment for the Phase I study in healthy volunteers from Korea and the study is expected to be completed by the third quarter of this year as originally planned.

Note to editors:

About Celltrion Healthcare

Celltrion Healthcare is committed to providing innovative and affordable medicines to promote patient access to advanced treatments. Their products are manufactured in state-of-the-art mammalian cell culture facilities, designed and built to comply with US FDA Good Manufacturing Practice guidelines and EU Good Manufacturing Practice guidelines. Celltrion Healthcare strives to provide cost-effective, high-quality solutions through an extensive global network spanning more than 110 different countries. For more information, visit: https://www.celltrionhealthcare.com/en-us

About COVID-19 1,2

Coronaviruses (CoVs) are a family of viruses that cause disorders ranging from the common cold to serious illness. The most recent coronavirus, SARS-CoV-2, is responsible for the COVID-19 disease and this new strain, discovered in 2019, is the cause of the current pandemic outbreak.

The most common symptoms of COVID-19 include fever, dry cough, and tiredness; however, other symptoms such as shortness of breath and shortness of breath may also be experienced. Most people infected with the virus will have mild to moderate symptoms, but older people and those with previous conditions such as cardiovascular disease and diabetes are more likely to develop a more severe form of COVID-19.

Up-to-date information on the outbreak is available from the World Health Organization at https://www.who.int/health-topics/coronavirus#tab=tab_1

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Bibliography

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

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

The statement in the original language is the official and authorized version of it. The translation is only a means of help and must be compared with the text in the original language, which is the only version of the text that will have legal validity.

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Source: businesswire.com

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