Published: 2021-01-14 23:51
Last Updated: 2021-03-08 10:22
The South Korean pharmaceutical company 'Celltrion', announced a drug treatment Wednesday, which combats COVID-19 by reducing the recovery time and the chance of severe cases of coronavirus from developing.
The treatment, called 'CT-P59', is in the second-phase trial study, with Celltrion announcing that they will be making the clinical data public.
CT-P59 is an anti-COVID-19 monoclonal antibody treatment candidate. Wednesday, the pharma giant submitted an application for conditional marketing authorization of the product to the Korean Ministry of Food and Drug Safety (KMFDS).
A conditional marketing authorization is a pragmatic tool for the fast-track approval of a medicine that fulfils an unmet medical need.
The treatment was tested on 327 patients who were infected with COVID-19 in order to assess the efficacy and safety of the treatment, also known as "Regdanvimab".
Notably, nearly 60 percent of trial participants had severe symptoms from COVID-19, including pneumonia.
The company said the treatment reduced the rate at which patients developed critical conditions, which require hospital care by 54 percent.
Celltrion added that there has been no serious adverse reactions among the trial participants.
Among patients aged 50 and over, the rate of developing severe cases decreased by 68 percent.
The company explained that the treatment reduced the recovery period by more than three days, explaining that among patients aged 50 years and over, the treatment reduced the recovery time by more than five or six days.
The South Korean Yonhap News Agency quoted a professor of medicine at Gachon University, Eom Joong-sik, saying: "The trial study proved that the treatment remarkably reduced the rate of patients developing into severe cases and at the same time reduced recovery time."
He also highlighted the treatment's efficacy among elderly patients, as the mortality rate of COVID-19 virus is especially prevalent among the aforementioned age bracket.
The KMFDS is reviewing the drug's safety and efficacy, which is a critical measure for the manufacturing and sales of the first home-grown treatment for COVID-19 in South Korea.
The company plans to conduct a third phase of clinical trials, which is a pivotal part of the study, in more than 10 countries, to obtain more comprehensive results for the safety and efficacy of the treatment.
The company will also submit an application for an emergency use authorization (EUA) to the US Food and Drug Administration (FDA), and a conditional marketing authorization to the European Medicines Agency (EMA) in the coming months.
The company is seeking to increase its manufacturing capacity to meet global and local demand, which is expected to reach a around two million doses.
It is worth noting that the treatment is injected intravenously for 90 minutes.