Celltrion said that it has confirmed the efficacy and safety of Regkirona, its Covid-19 antibody treatment, presenting the top-line results of its global phase 3 clinical trial of the treatment.
The company had conducted trials on 1,315 mild and moderate Covid-19 patients in 13 countries, including Korea, the U.S., Spain, and Romania, since January and completed the administration of Regkirona in April.
After 28 days of treatment, the company announced the top-line result on Monday.
"Unlike phase 2 clinical trial, which had a limited number of patients for both treatment group and placebo group, Celltrion developed four major evaluation indicators related to the severe exacerbation rate and clinical symptom improvement time in this large-scale phase 3 clinical trial, which involved a far larger number of patients," the company said.
The statistical analysis of the result confirmed a clear difference between the treatment group and the placebo group in all endpoints, it added.
Compared to the placebo group, the patient group administered with Regkirona (40 mg/kg) reduced the rate of severe exacerbation by 72 percent among high-risk patients, such as the elderly and those who had underlying diseases, the study's primary endpoint.
Regkirona also reduced the rate of severe exacerbation in all patients by 70 percent, proving a statistically significant result and fulfilling the secondary endpoint.
The company stressed that Regkirona shortened the time to improve clinical symptoms by more than 4.7 days for patients in the high-risk group -- 9.3 days in the Regkirona group vs. 14 days in the placebo group.
It also shortened the time to improve clinical symptoms by 4.9 days for all patients -- 8.4 days in the Regkirona group vs. 13.3 days in the placebo group.
In the safety evaluation, the number of patients who experienced adverse reactions in the Regkirona group and the placebo group was similar. The majority of adverse reactions were mild, revealing few specific differences in terms of safety.
Celltrion will soon submit 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).
"Through a large-scale global phase 3 clinical trial, the company has proven that administering Regkirona to patients with mild to moderate Covid-19 significantly lowers the rate of developing severe patients and recovers quickly," a company official said. "As the results of phase 3 clinical trial have proven the efficacy and safety of Regkirona as a treatment for Covid-19, we expect that the treatment will be more actively prescribed to patients worldwide."
The company plans to unveil the complete results of the global phase 3 clinical trial of Regkirona in the first half of the year. It intends to present the results during the 2021 European Society for Clinical Microbiology and Infectious Diseases (ECCMID) held online from July 9-12.