Celltrion's 'Rekkirona' Demonstrates Efficacy and Safety Through Global Phase 3 Clinical Trials (Comprehensive)

Top-line Results of Phase 3 Clinical Trial Released

Over 70% Reduction in Severe and Fatal Cases
Clinical Symptom Improvement Shortened by 3.8 to 4.9 Days

Effectiveness Against Variants to Be Announced Later

A hospital official is examining Celltrion's COVID-19 antibody treatment 'Rekkironaju'. [Image source=Yonhap News]

[Asia Economy Reporter Lee Chun-hee] 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 top line data is used to determine the success or failure of the clinical trial. It includes primary efficacy results, major secondary efficacy evaluation results, and safety results from the 28-day clinical outcomes after administration.

Celltrion's COVID-19 antibody treatment 'Rekkironaju' (Photo by Celltrion)

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 with a single dose, followed by a 28-day treatment period, leading to these results.

Unlike the Phase 2 trial (total 327 patients) 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 designated and statistically analyzed. The results showed a clear difference between the treatment and placebo groups with all four indicators yielding 'p<0.0001'.

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

The time to clinical symptom improvement was also shortened. For high-risk patients, the treatment group showed 9.3 days compared to at least 14 days in the placebo group, a reduction of more than 4.7 days based on a 48-hour criterion. For the overall patient group, the time was shortened from 13.3 days to 8.4 days, a 4.9-day improvement. Based on a 24-hour criterion, the time was reduced by 4.1 days for high-risk patients and 3.8 days for the overall patient group, both showing statistically significant results.

In the safety evaluation analysis, the number of patients experiencing adverse reactions at least once was similar between the Rekkirona treatment group and the placebo group. During this process, regarding one patient in the treatment group who experienced a serious drug-related adverse reaction, Kim Sung-hyun, Head of Medical Affairs at Celltrion, explained, "Patients may experience infusion-related adverse reactions such as skin rash and itching during drug administration," adding, "The patient developed a skin rash, received treatment, and recovered." Most other adverse reactions were mild, showing no particular safety concerns.

Reckonaju, a COVID-19 antibody treatment, is being produced at Celltrion's 2nd factory in Songdo-dong, Yeonsu-gu, Incheon. [Image source=Yonhap News]

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 formal product approval processes. Head Kim stated, "We plan to apply for approval to change the drug administration time," and added, "We also plan to attempt expanding the patient groups receiving the drug based on the large-scale clinical results."

The major clinical results announced on this day did not include information related to COVID-19 variants. Head Kim explained, "Since the drug must be administered quickly to patients, the system to identify which variant is involved is not yet smooth," and added, "Considering variants during clinical trials and conducting trials accordingly is inevitably quite limited." However, he noted, "If we collect and analyze data on the variant distribution among all patients, we will be able to understand how Rekkirona performed in patients infected with variant viruses," promising to disclose those results soon.

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