Celltrion’s antibody treatment “Recyronaju (ingredient name legdanvimab, developed name CT-P59)”, which has been expected as a treatment for a new Korean coronavirus infection (Corona 19), has been unveiled.
At the ‘2021 High1 New Drug Development Symposium’ held on the 13th, Professor Um Joong-sik of Gachon University Gil Hospital, who participated as a clinical researcher (PI) in the global phase 2 clinical trial of Rekkirona, presented the research results.
Professor Eom Joong-sik said on this day, “We expect that Rekirona will be able to open a new chapter in high-risk treatment by preventing the outbreak of severe corona19 patients and shortening the treatment period. It is expected that it will play a big role in the management of medical resources because it can reduce the burden on medical institutions and give considerable room for treatment.”
The study was conducted until the end of the study of 307 mild and moderate patients among 327 recruited patients, of which 124 (40.4%) were mild and 182 (59.3%) were moderately ill with pneumonia. Was.
In particular, the feature of this study is that a large number of patients over 50 years of age, who are relatively older, and high-risk patients with high possibility of severe progression with pneumonia were included. The researchers figured out how severe the disease could be prevented by administering Rekirona injection in the early stages of infection.
The clinical trial was divided into 40mg/kg, 80mg/kg, and a control group (placebo), and the results were examined on the 28th day after administration of Rekirona.
According to Professor Eom, the incidence of severe patients in the 40mg group was 4%, which was a 54% reduction compared to 8.7% in the placebo group. In the case of moderately ill patients with pneumonia, the incidence of severe patients was 6.5%, which was a 59% reduction compared to 15.8% in the placebo group. In the case of moderately ill patients over 50, the incidence of severe patients was 7.5%, down 68% compared to 23.7% in the placebo group.
Accordingly, Professor Eom expected that Rekirona could reduce the severe progression of Corona 19 by more than half.
Prof. Eom said, “In the case of mild patients in Korea, most of them enter life treatment centers, and this will have the effect of reducing the severe progression of these inmates. It is expected that the hospital stay can be shortened even when hospitalized due to moderate progression I do” he emphasized.
He added, “It will be possible to significantly reduce the efforts to secure treatment beds for severely ill patients, which have been difficult,” he added. “From a medical institution’s point of view, space and manpower, that is, resources, can be managed very efficiently,” he added.
In addition, Prof. Eom explained that when looking at the time taken for clinical recovery until the 14th day after administration, the Rekirona injection group showed a steeper recovery trend. In the 40mg group, the median recovery period was 5.4 days, which was about 3.4 days shorter than the placebo group 8.8 days.
In particular, in the case of moderately ill patients with pneumonia, clinical recovery was 5.7 days, which was about 5.1 days shorter than 10.8 days in the placebo group. In the case of moderately ill patients over 50 years of age, the recovery period was 6.6 days, short of 6.4 days compared to 13 days in the placebo group.
Professor Eom said, “It’s almost half the clinical recovery period. It seems that it is more effective for people over 50 years old and can shorten the treatment period by about a week.” “When treating patients with moderate or higher severity in the hospital, it is recommended to be hospitalized for about 10 days with clinical improvement. “Reckirona can shorten the hospitalization recommendation period by nearly a week, which will serve as a basis for drastically reducing the burden of hospital bed operation and medical resources.”
The rate of reduction of the virus exposure area in the body for viral suppression effect was also much faster and steeper in the administration group than in the control group. In particular, on the 7th day, the virus concentration decreased by about 1,500 times, which is the number required for 3-4 days in the control group.
In addition, Prof. Eom said regarding the safety evaluation of Rekirona, “When looking at the number of patients with more than one reaction in this study, there was no statistical difference between 27% in the administration group and 30.9% in the control group. “There were no serious adverse reactions, deaths, or discontinuation of the study.”
“Through this, we can confirm that there are no safety issues in Rekirona overall. It is possible to predict that if an injection can be administered, it can be administered in a wide range.”
In addition, Professor Eom said that Rekkironaju is still ineffective when compared to previously developed Lily and Regeneron.
He argued, “Compared to the two existing single antibody treatments, although initial pneumonia in clinical participants is an important risk factor for worsening symptoms, it has been clinically proven that Rekyronase is effective.”
“Because this is a phase 2 study, it is necessary to proceed with phase 3 for more patients,” he said. “The results of this study alone are expected to allow Rekkironazu to play a very important role in the corona field.” did.
On the other hand, Prof. Eom on this day asked the reason for the rather high antibody concentration, “At the time of the initial study design, it was assumed that patients would need a much higher dose of antibody to suppress the Corona 19 virus compared to normal immunoglobulin treatment.” Revealed.