Celltrion said it presented the global phase 3 trial results of its antibody Covid-19 treatment, Regkirona, at a session of the European Congress of Clinical Microbiology & Infectious Disease (ECCMID) on Monday.

Dr. Oana Sandulescu of Carol Davila University of Medicine and Pharmacy in Romania makes an oral presentation of the global phase 3 clinical trial results of Celltrion’s Covid-19 antibody therapy, Regkirona, at the 31st session of the European Congress of Clinical Microbiology & Infectious Disease (ECCMID) on Monday.
Dr. Oana Sandulescu of Carol Davila University of Medicine and Pharmacy in Romania makes an oral presentation of the global phase 3 clinical trial results of Celltrion’s Covid-19 antibody therapy, Regkirona, at the 31st session of the European Congress of Clinical Microbiology & Infectious Disease (ECCMID) on Monday.

Dr. Oana Sandulescu from Carol Davila University of Medicine and Pharmacy in Romania made the oral presentation. The trial was conducted on 1,315 mild to moderate Covid-19 patients for 28days.

The massive phase 3 clinical trials made a statistical analysis of the two evaluation indexes -- the duration of recovery of clinical symptoms and the rate of aggravation of moderate patients -- calculating the rate of patients who died or progressed to severe symptoms in need of hospitalization or mechanical ventilation.

The analysis showed reduced cases of progression to severe symptoms. In the high-risk patient groups administered with Regkirona, the chances of progression to severe symptoms fell by 72 percent compared to the placebo group. In all patients, the percentage of chances dropped by 70 percent.

Also, the recovery time of clinical symptoms was shortened by 4.9 days for all patients and 4.7 days for the high-risk patient groups.

In addition, the virus concentration in the body of the group with seven days of Regkirona administration was significantly lower than the placebo group. In terms of safety, most of the undesirable effects stood at mild levels, showing little significance to report.

“Celltrion has proved the safety and effectiveness of Regkirona in one of the authoritative international conferences by making an oral presentation of its global phase 3 trial results,” a company official said, “The company will speed up the approval process based on the results and make best efforts to fight against the outbreak of the Covid-19 variants.”

Celltrion has conducted animal trials against Beta and Gamma variants, from which neutralizing capacity was found. It also plans to secure the results of animal trials against the Delta variant this month.

Copyright © KBR Unauthorized reproduction, redistribution prohibited