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January 4, 2022

Celltrion’s antibody maintains neutralisation ability against Omicron

In a Phase I trial, CT-P63 showed to be safe and well-tolerated without any treatment-associated adverse events observed.

By Vishnu Priyan

Celltrion Group has reported that its monoclonal antibody CT-P63 maintained a robust neutralising ability against the Omicron variant of the SARS-CoV-2 virus in an experiment.

CT-P63 acts on the virus’ spike receptor-binding domain (RBD) to treat Covid-19.

The latest structural analysis by X-ray crystallography and neutralisation data is from pseudo-virus testing carried out by the company in collaboration with the US National Institutes of Health (NIH).

The findings from Omicron variant assays and animal model studies are expected in the first quarter of this year.

The antibody therapy was also found to be safe and well-tolerated without any substantial treatment-associated adverse events reported in a placebo-controlled, randomised, double-blind Phase I clinical trial.

The trial, which enrolled 24 healthy participants in Poland to analyse the safety, tolerability and pharmacokinetics of CT-P63, also met its primary goals.

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CT-P63 previously demonstrated neutralising activity against the SARS-CoV-2 variants, including the Alpha, Beta, Gamma and Delta.

Celltrion Healthcare medical and marketing division head Dr HoUng Kim said: “The positive results demonstrate the potential of our cocktail therapy to retain neutralising ability against the Omicron variant.

“We are confident that our antibody platform including Regkirona and CT-P63 will provide significant benefit for patients with Covid-19.”

An intravenous therapy, Regkirona is claimed to efficiently treat Covid-19 patients admitted to hospital at an early stage.

In addition, the company anticipates holding talks with several regulatory authorities worldwide to commence a large-scale clinical trial for its nebulised cocktail therapy comprising CT-P63 plus Regkirona.

Last July, the company’s regdanvimab (CT-P59) showed strong neutralising activity against the Delta variant in an in-vivo efficacy study.

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