Celltrion reports progress in phase 3 trial of COVID-19 drug candidate

Celltrion has completed administration of an experimental COVID-19 antibody treatment to a total of 1,300 people participating in its phase 3 clinical trial, the company announced Monday.

The final stage of human tests of the drug candidate, known as Regkirona or CT-P59, is being conducted in 13 countries, including Korea, the US, Spain and Romania, the firm added. The treatment has cleared an emergency use authorization in Korea in February.

The Seoul-based drug developer, specializing in biosimilars, said no unusual reaction was detected in the patient groups who received the treatment.

The company plans to collect results of the tests and plans to submit them to both local and foreign health authorities by end June this year.

“(Celltrion) has secured enough patients (for phase 3 clinical study) and expects to speed up discussions to export the COVID-19 antibody treatment,” said an official at Celltrion. “The company would focus on successfully completing the phase 3 clinical trial by the first half this year,” the official added.

Earlier in February, the Ministry of Food and Drug Safety approved use of Regkirona for treating mild patients in high-risk groups and adult patients with moderate symptoms, on the condition it conducts a phase 3 clinical trial and submits the results in the future.

Celltrion expects that Regkirona would be recommended for use on wider groups of patients once its safety and efficacy are proven via the phase 3 clinical trial.

The company has already completed manufacturing enough doses of the drug for 100,000 patients. The drugmaker said it is capable of producing Regkirona for 3 million people a year.

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