Celltrion "Rekkirona, Proven Efficacy and Safety Through Global Phase 3 Clinical Trials"

Celltrion's COVID-19 antibody treatment 'Rekkironaju'
[Image source=Yonhap News]

[Asia Economy Reporter Chunhee Lee] Celltrion's COVID-19 antibody treatment 'Rekkirona (CT-P59)' has proven its efficacy and safety by achieving 'statistically significant results' through global Phase 3 clinical trials.

Celltrion disclosed the key results (top line) of the global Phase 3 clinical trial of Rekkirona on the 14th.

The global Phase 3 clinical trial of Rekkirona was conducted from January at 58 hospitals across 13 countries including South Korea, the United States, Spain, and Romania, involving 1,315 patients with mild to moderate COVID-19. This included 880 high-risk patients. The administration was completed in April, followed by a 28-day treatment period, leading to these results.

Unlike the Phase 2 trial, which had limitations in the number of patients in the treatment and placebo groups, the large-scale Phase 3 trial secured a sufficient number of 1,315 patients. Four major evaluation indicators (one primary endpoint and three key secondary endpoints) related to the most important clinical outcomes?rate of severe disease progression and time to clinical symptom improvement?were statistically analyzed. The results showed a 'p<0.0001' value for all four indicators, demonstrating a clear difference between the treatment and placebo groups.

In terms of efficacy, among patients administered Rekkirona (40 mg/kg), the rate of severe cases requiring hospitalization or death was reduced by 72% in high-risk patients such as the elderly or those with underlying conditions, and by 70% in the overall patient population compared to the placebo group, confirming statistical significance.

The time to clinical symptom improvement was also shortened by more than 4.7 days in high-risk patients, with the treatment group showing 9.3 days versus at least 14 days in the placebo group based on a 48-hour criterion. For the overall patient population, the time was reduced from 13.3 days to 8.4 days, a 4.7-day improvement. Based on a 24-hour criterion, the time was shortened by 4.1 days for high-risk patients and 3.8 days for the overall patients, both showing statistically significant results.

Safety evaluation analysis showed that the number of patients experiencing adverse reactions at least once was similar between the Rekkirona and placebo groups. Most adverse reactions were mild, with no notable safety concerns.

Celltrion's COVID-19 antibody treatment 'Rekkirona (CT-P59)' (Photo by Celltrion)

Celltrion plans to submit these Phase 3 clinical trial results to global regulatory agencies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) to continue the formal product approval process.

A Celltrion official stated, "Through this large-scale global Phase 3 clinical trial, we have demonstrated that administering Rekkirona to patients with mild to moderate COVID-19 significantly reduces the progression to severe disease and promotes rapid recovery. Having proven the efficacy and safety of Rekkirona, we expect it to be more actively prescribed to patients in medical settings both domestically and internationally."

This content was produced with the assistance of AI translation services.