Celltrion proves efficacy of COVID-19 antibody treatment in phase 3 trial

South Korean pharmaceutical firm Celltrion announced Monday that its COVID-19 antibody treatment has significantly shortened the recovery time and rate of progression for severe symptoms.

The firm disclosed top-line results from a global phase 3 clinical study of Regkirona, or CT-P59, which was conducted with 1,315 patients from 13 countries around the globe between January and April.

Celltrion found Regkirona reduces the risk of cases progressing to severe COVID-19 by 70 percent. Among high-risk groups, the progression rate to a severe case was cut by 72 percent.

Patients treated with Regkirona also reported a significantly shortened recovery time, which was 4.7 to 4.9 days faster compared to placebo groups.

Celltrion also reported that the company’s COVID-19 antibody treatment has shown no significant adverse reaction, though some mild and temporary reactions have been reported.

The firm plans to soon report the top-line results to the US Food and Drug Administration and European Medicines Agency to accelerate the process for formal authorizations.

It also plans to announce full-scale results from the phase 3 clinical trial in the coming weeks. It will present them at the upcoming European Congress of Clinical Microbiology & Infectious Diseases in July.

Celltrion will later look into the results to see if the antibody treatment is effective against COVID-19 variants.

“In July, (Celltrion) will check if there were patients with COVID-19 variants and see if the treatment had any effects on them,” an official there said.

Regkirona is a monoclonal antibody treatment against COVID-19. A monoclonal antibody is a type of protein that has been designed to attach to a specific structure.

Regkirona has won approvals for emergency application in many countries. The South Korean drug safety agency granted conditional approval to use Regkirona in February, making it the first homegrown treatment for COVID-19.

In Korea, the number of patients treated with Regkirona currently numbers around 4,000, according to Celltrion.

By Shim Woo-hyun (ws@heraldcorp.com)