CelltrionHealthcare

Celltrion launches human clinical trial of potential COVID-19 antiviral antibody treatment following positive pre-clinical results

· The Phase I study of Celltrion’s COVID-19 antiviral antibody treatment candidate in healthy volunteers is set for completion by Q3 this year

· Celltrion’s COVID-19 antiviral antibody treatment candidate has been proven to be effective in neutralising different kinds of coronavirus related strains including the mutated G-variant strain of SARS-CoV-2 (D614G variant)

· Further human studies across Europe including the UK are planned – the company anticipates promising preliminary results from pivotal studies in mild and moderate COVID-19 patients by the end of the year

JULY 17th 2020, INCHEON, KOREA– Celltrion Group today announced the launch of its Phase I human clinical trial investigating a potential antiviral antibody treatment for patients with COVID-19. The in-human study follows positive pre-clinical results for the treatment candidate and subsequent approval of the Investigational New Drug application by the Korean Ministry of Food and Drug Safety (MFDS). The potential treatment will also be investigated for use as a preventative measure.

The Phase I clinical trial aims to enroll 32 healthy volunteers in collaboration with Chungnam National University Hospital. The study will evaluate the safety of the antiviral antibody treatment candidate in healthy participants who have not been diagnosed with COVID-19. The trial’s completion is expected by Q3 of this year.

Celltrion is set to conduct a further in-human Phase I clinical trial of the antiviral treatment candidate in mild COVID-19 patients across Europe, including the UK,which will be followed by global Phase II/III trials in patients with mild and moderate COVID-19. Celltrion anticipates promising preliminary results from pivotal studies by the end of the year.

In addition, a clinical trial investigating the use of the potential antiviral antibody treatment as a preventative measure, by enrolling people in close contact with COVID-19 patients globally, is also planned. The top line data for this trial is anticipated in Q1 of 2021.

Furthermore, Celltrion has previously demonstrated its antiviral antibody treatment to be effective in neutralising the mutated G-variant strain (D614G variant),[1] which is associated with the increased viral transmission and wide spread of COVID-19.[2]

“The initiation of this in-human clinical trial is a key milestone in the development of our antiviral antibody treatment,” said Dr. Sang Joon Lee,Senior Executive Vice President of Celltrion. “We were encouraged by the positive safety and efficacy results in our pre-clinical studies, and we are now ready to move into in-human clinical trials as we originally planned. We remain committed to carrying out local and global clinical studies with the goal of commencing mass production of the therapeutic antibody treatment in the latter half of this year.”

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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-19[3],[4]

Coronaviruses (CoV) are a family of viruses that lead to illnesses from the common cold to severe diseases. Novel coronavirusSARS-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.

There are currently no specific vaccines or treatments approved for 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

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