Celltrion Group has completed enrolment of 327 patients with mild-to-moderate SARS-CoV-2 infection symptoms to evaluate anti-Covid-19 monoclonal antibody treatment candidate CT-P59 in the global Phase II clinical trial.
CT-P59 was selected from a pool of antibody candidates that showed the highest potency in neutralising the SARS-CoV-2 virus.
The randomised, double-blind, placebo-controlled and parallel-group trial will analyse the efficacy and safety of CT-P59 in combination with standard of care in Covid-19 patients.
It has a placebo group as well as low concentration and high concentration groups.
On obtaining positive results from the global Phase II pivotal trial, Celltrion plans to submit emergency use authorisation (EUA) to the Korean Ministry of Food and Drug Safety (MFDS).
In addition, the company anticipates starting a global Phase III trial in over ten countries to achieve more comprehensive safety and efficacy results of the antibody therapy.
Celltrion senior executive vice-president Dr Sang Joon Lee said: “We managed to successfully enrol 327 patients for the global Phase II trial and the results from the trial are expected in the coming weeks.
“We plan to compile a robust data set to support the planned emergency use application, expected as early as the end of the year, subject to positive study results.”
Furthermore, the company has started a post-exposure prophylaxis clinical trial to analyse the preventive effect and safety of the antibody treatment candidate.
The trial will also evaluate whether CT-P59 can elicit a neutralising antibody response to prevent the virus from infecting human cells.
To meet the global and domestic demand, the company is working to increase its manufacturing capabilities for producing the Covid-19 treatment candidate for about two million people per year.