[종합] Celltrion reduces the incidence of critically ill patients by 54% in phase 2 clinical trials of corona antibody treatment… Recovery period ↓

Celltrion’s novel coronavirus infection (hereinafter referred to as COVID-19) antibody treatment’Recyronaju’ (ingredient name Regdanvimab, development name CT-P59) is likely to develop severely when administered to mild to moderate Corona 19 patients Decreased by 54%. It was lowered by 68% for those aged 50 and over, showing a greater effect in the high-risk group.

On the 13th, Professor Um Joong-sik, a professor of infectious medicine at Gachon University Gil Hospital, announced the results of the global clinical phase 2 of Rekkirona at the ‘2021 High1 New Drug Development Symposium’ at the Korean Pharmacy Society conference.

This phase 2 shortens the recovery period for 7 corona19 symptoms, including fever, and the time it takes to transition from positive to negative during virus testing for 327 mild to moderate corona19 patients in Korea, Romania, Spain and the United States. Aimed at confirmation. Moderate patients are patients with pneumonia. It accounted for 60% of all subjects.

As a result of the study, the incidence of development of mild and moderate patients to severe (inpatient treatment required) decreased by 54% in the Rekirona injection group (40 mg/kg) compared to the placebo group. It was a 68% decrease in patients aged 50 years or older with moderate symptoms.

The time to show clinical recovery was 5.4 days in the Rekyrona-treated group and 8.8 days in the placebo-treated group.

In particular, the time taken to show clinical recovery when taking Rekirona injection in the moderate or moderately ill patients over 50 years old was shortened by 5-6 days or more compared to the placebo group.

In addition, the virus concentration in the body was significantly lower than that of the placebo group on the 7th day because of the rapid reduction of virus in the body when Rekirona was administered, and it was found that the placebo group reached the 7th day of the treatment group only after the 10th day.

In the safety evaluation results, no specific matters were found overall, which proved excellent safety. Celltrion said that there were no serious adverse reactions, deaths, or discontinuation of the study due to adverse reactions after administration of the investigational drug.

Prof. Eom said, “Rekirona has proved through this clinical trial that the rate of development into severe patients when administered to mild and moderate corona19 patients is significantly reduced and recovers rapidly.” I think that vaccines as well as treatments are essential options to prevent deterioration.”

An official from Celltrion said, “If Rekirona receives conditional permission from the Ministry of Food and Drug Safety, we have already finished producing 100,000 people and are thoroughly preparing a supply plan so that it can be supplied to the medical field immediately.” We are systematically preparing a treatment plan for up to 2 million people, so we are making every effort to respond to global demand.”

Celltrion plans to conduct phase 3 clinical trials in more than 10 countries around the world to further verify the safety and efficacy of Rekirona strain confirmed in phase 2 clinical trials in a wider range of patients.