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.
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“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.
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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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