Policy & Regulation
Celltrion gets green light for UK trial of potential COVID-19 antiviral antibody treatment
31 July 2020 -

South Korean biopharmaceutical company Celltrion (KRX:068270) said on Thursday that it has received UK approval for a trial of CT-P59, a potential antiviral antibody treatment for COVID-19.

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) approved the company's Clinical Trial Authorisation (CTA) application for a Phase I clinical trial with CT-P59 in patients with mild symptoms of SARS-CoV-2 infection. The trial is intended to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of CT-P59.

A Phase I clinical trial in healthy volunteers is currently ongoing in South Korea.

Celltrion also plans to conduct global Phase II/III trials in patients with mild and moderate COVID-19 and anticipates results from these studies by the end of the year.

Another trial will investigate the use of CT-P59 as a preventative measure, by enrolling people in close contact with COVID-19 patients.

In pre-clinical data the treatment candidate demonstrated a 100-fold reduction in viral load of SARS-CoV-2, as well as a reduction in lung inflammation, Celltrion said.

The company intends to start full-scale commercial production of CT-P59 in September and is securing sufficient manufacturing capacity to produce enough of the potential COVID-19 treatment for up to 5 million patients a year.

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