August 26, 2020 -- The Korean Ministry of Food and Drug Safety has approved Celltrion's investigational new drug application for a phase I clinical trial of CT-P59, a COVID-19 antiviral antibody treatment candidate.
The trial has already begun enrolling patients with mild symptoms to evaluate the safety, tolerability, efficacy, pharmacokinetics, and immunogenicity of CT-P59. CT-P59 was identified through screening of antibody candidates and the selection of those with the highest potency in neutralizing SARS-CoV-2 in preclinical development.
The company expects study results from phase II/III trials in patients with mild symptoms, phase III trial in severe-to-moderate COVID-19 patients, and a prevention clinical trial by the end of 2020.
Preparation for a phase I study in healthy volunteers in South Korea has been completed, and the company expects this trial to be completed later this year.
In July, the company began a clinical trial of CT-P59 in the U.K. following a clinical trial authorization from the U.K. Medicines and Healthcare products Regulatory Agency.
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