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This image, provided by South Korea's pharmaceutical giant Celltrion on Dec. 29, 2020, shows the company's anti-COVID-19 monoclonal antibody treatment. (Celltrion) |
South Korea's pharmaceutical giant Celltrion Inc. is expected to release the outcome of its second phase clinical study of anti-COVID-19 monoclonal antibody treatment later this month, company officials said Tuesday.
The Korean Ministry of Food and Drug Safety is currently reviewing conditional approval of CT-P59, also known as Regdanvimab, a move that could potentially lead to manufacturing and sales of the first homegrown treatment.
This submission was based on the data from the global phase two clinical trial, with the top-line data expected to be presented during a forum slated for Jan. 13, they said.
"We have closely cooperated with the ministry for an early release of the clinical study data," said a company official who asked not to be named, adding that the drug candidate shows efficacy in early treatment.
The trial study enrolled 327 patients with mild-to-moderate symptoms of COVID-19 to evaluate the efficacy and safety of CT-P59 in combination with standard of care in patients with the infection.
Celltrion has said that CT-P59 shortened the recovery time of patients with no reported side effects. The company also said that the drug kills the coronavirus within 4-5 days, effectively protecting patients with mild symptoms from developing into severe cases.
Celltrion has also said it plans to initiate a global phase three clinical trial, a pivotal part of the study in more than 10 countries to obtain more comprehensive safety and efficacy results of CT-P59.
The company plans to submit an application for Emergency Use Authorization to the US Food and Drug Administration (FDA) and for Conditional Marketing Authorization to the European Medicines Agency (EMA) for CT-P59 in the coming months. (Yonhap)
