Celltrion receives Korean MFDS approval to initiate Phase I trial of COVID-19 antiviral antibody treatment candidate, CT-P59, in patients

·          The Korean Ministry of Food and Drug Safety (MFDS) approved Celltrion’s Investigational New Drug (IND) application to initiate a Phase I trial of CT-P59 in patients

·          By the end of the year Celltrion anticipates global pivotal study results from Phase II/III trials in patients with mild symptoms of COVID-19, the Phase III trial in moderate-to-severe patients, and the prevention trial

·          As part of the prevention clinical trial, Celltrion will enrol those who are in close contact with COVID-19 patients and those with no symptoms to investigate the potential short-term preventative effects of CT-P59 against SARS-CoV-2 infection

AUGUST 26^th 2020, INCHEON, KOREA – Celltrion Group announced today that the Korean Ministry of Food and Drug Safety (MFDS) has approved the company’s Investigational New Drug (IND) application for a Phase I clinical trial of CT-P59, a COVID-19 antiviral antibody treatment candidate. Celltrion has initiated enrolment of patients with mild symptoms of SARS-CoV-2 infection and the clinical trial is set to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of CT-P59.

Celltrion anticipates global pivotal study results from the Phase II and III trials in patients with mild symptoms, the Phase III trial in patients with moderate-to-severe COVID-19, and the prevention clinical trial, by the end of the year. Celltrion plans to enrol people that are in close contact with COVID-19 patients and those with no symptoms as part of a prevention clinical trial to evaluate neutralising antibody response so as to prevent the virus from infecting cells.

“We have initiated an in-human global Phase I clinical trial of CT-P59 in mild COVID-19 patients and we plan to conduct further global Phase II and III trials in this patient group. In addition, Celltrion plans to combine Phase II and III trials in patients with moderate-to-severe COVID-19 with the prevention clinical trials.,” said Dr. Sang Joon Lee, Senior Executive Vice President of Celltrion. “We are extremely encouraged by the consistent progress we are making in preparation for our CT-P59 clinical trials in various settings, and we remain on track to reach our upcoming milestones.”

In July, Celltrion initiated a Phase I trial of CT-P59 in the UK following the approval of the clinical trial authorisation (CTA) application from 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 in Korea and the study is set for completion by Q3 this year as originally planned.

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-19^[i],[ii]

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

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

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