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Reporter Seo Yoon-seok
Corona 19’CT-P59 ‘antibody .. Confirmation of safety and antiviral effect in phase 1 of a patient with mild Corona 19
Celltrion confirmed the safety and reducing effect of the virus in the phase 1 clinical trial of Corona 19 ‘CT-P59’ antibody.
According to Celltrion on the 6th, Jin-yong Kim, head of the Incheon Medical Center Infectious Medicine Department, orally presented the results of the phase 1 clinical trials of CT-P59 at the ‘Fall 2020 Conference of the Korean Society of Infectious Diseases and Korean Antimicrobial Therapy ‘held online on days 5 and 6. Kim participated in the Celltrion Corona 19 antibody clinical trial’ CT-P59 ‘.
This clinical trial evaluated the safety and tolerability of CT-P59, changes in clinical symptoms, and viral changes in 18 patients with mild corona19 at three clinical trial institutions in Europe, including Korea.
As a result, Celltrion explained that in the CT-P59 group, the average time to recovery from symptoms was reduced by 44% compared to the placebo group. Recovery was 3.9 days in the CT-P59 group and 7 days in the placebo group. In particular, as a result of the administration of CT-P59 to patients with high initial virus concentration, the result that the amount of virus decreased more rapidly compared to the placebo group was confirmed. Also, all the patients taking CT-P59 recovered, but some of the placebo groups got worse. Most of the participants in this clinical trial were elderly and, unlike the placebo group, none of the patients who received CT-P59 developed serious disease.
Since no abnormal cases were observed in the CT-P59 administration group, safety and tolerability were also confirmed.
A Celltrion official said: “Through this clinical outcome announced at the conference, we have confirmed the initial therapeutic effect of COVID-19 antibody treatment,” said: “Phase 1 is limited to accept the results definitively due to the small number of patients. “The adjudication test will produce results that meet the criteria.”
On the other hand, Celltrion plans to conduct a large-scale global clinical trial based on the results of phase 1 clinical trials of CT-P59, the corona19 antibody. Celltrion is currently in phase 2 and 3 clinical trials in Korea, including Korea, and plans to secure interim results by the end of this year. Additionally, Celltrion has been producing process verification batches to enable mass delivery as soon as drug development is complete since last September.
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