Celltrion Group has initiated a Phase I clinical trial of its investigational antiviral antibody candidate for the treatment of patients with Covid-19.
The Korean Ministry of Food and Drug Safety (MFDS) approved the investigational new drug application for the trial, which follows positive data in pre-clinical studies.
Celltrion said that the antibody treatment will also be assessed as a preventative option.
Celltrion Group senior executive vice-president Dr Sang Joon Lee said: “The initiation of this in-human clinical trial is a key milestone in the development of our antiviral antibody treatment.
“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.”
Conducted in partnership with Chungnam National University Hospital, the Phase I trial in Korea will investigate the safety of the antibody treatment candidate in 32 healthy volunteers.
The trial is expected to be completed by the third quarter of this year.
Celltrion intends to perform a separate Phase I study of the antiviral antibody candidate in patients with mild Covid-19 across Europe, including in the UK.
The company is also planning global Phase II/III trials in patients with a mild and moderate form of the disease. It expects preliminary data from these studies by the end of this year.
Another study will evaluate the treatment as a preventative measure in people who were in close contact with Covid-19 patients worldwide. The top-line results from this trial are expected in the first quarter of next year.
Previously, the antiviral antibody treatment candidate was found to be effective in neutralising the mutated G-variant strain (D614G variant), which is said to be involved in increasing Covid-19 transmission.
Last month, Celltrion Healthcare UK agreed to provide its anti-tumour necrosis factor (TNF) therapy, Infliximab (CT-P13), for assessment in the CATALYST clinical trial.
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