Celltrion's COVID-19 antibody tx reduces progression by 54%

On the 13th, phase II clinical trial of COVID-19 was first unveiled at the New Drug Development Symposium

Confirmed effect of reducing symptom recovery period and severe progression rate

Rekirona

The result of Phase II clinical trial of Rekirona (Regdanvimab), COVID-19 antibody treatment developed by Celltrion, has been revealed for the first time.

 

It is evaluated that it is useful to efficiently manage medical resources while reducing the incidence of severe patients requiring inpatient treatment by more than half and reducing the recovery period.

 

Celltrion presented the results of global II clinical trials related to Rekirona at the 2021 High1 New Drug Development Symposium online event hosted by the pharmaceutical society of Korea on the 13th.

 

This is a multicenter study that compared the efficacy and safety of 327 patients with mild or moderate COVID-19 infection with standard treatment and administration of Rekirona or placebo.

 

327 COVID-19 patients from Korea, Romania, Spain and the United States participated and completed the final medication on November 25 last year (Korean time).

 

The data introduced on this day are the results of an analysis of 307 mild and moderate patients who were confirmed to be infected with COVID-19 immediately before administration.

 

The presentation was made by Professor Joong Sik Eom (Infectious Internal Medicine, Gachon University Gil Medical Center), chief researcher (PI) and advisor.

 

The researchers set the percentage of patients who died or required hospitalization or oxygen therapy due to COVID-19 infection by the 28th as the efficacy evaluation index.

 

As a result of the analysis, when Rekirona 40mg/kg was administered to patients diagnosed as mild or moderate, the probability of progression to severe was decreased by 54% compared to placebo group.

 

The severe progression rate of moderately ill patients over 50 is 68%.

 

The benefits are expected to increase when Rekirona is administered to patients with higher disease severity in the elderly.

 

The time it takes for the symptoms of COVID-19 to disappear was 5.4 days in Rekirona group, which was shortened by more than 3 days from 8.8 days in the placebo group.

 

In the case of moderate or moderately ill patients over 50 years old, the time it took for symptom recovery after administration of Rekirona was more than 5-6 days with placebo.

 

After administration of Rekirona, the time required for the concentration of virus in the body to decrease by 1500 times was 7 days, which was 3 days shorter than 10 days in the placebo group.

 

No serious adverse events, including death, were reported among the patients participating in the clinical trial.

 

There were no cases of discontinuing the study due to adverse events.

 

Professor Eom said, "When Rekirona is administered to mild or moderate COVID-19 patients, it has been proven to significantly reduce the rate of progression to severe and shorten the recovery time.

 

56% of the participating patients over 50 years old and those with pneumonia were proven to be an encouraging result in that the participation rate of the high-risk group was high at 60%." Although it is phase II clinical trial, it is expected that it will greatly contribute to the management of medical resources by securing treatment beds to reduce confusion in the treatment field and to provide conditions to focus on moderately high-risk patients.

 

Celltrion officials have completed production for 100,000 people in preparation for conditional marketing authorization of Rekirona.

 

It is planning to conduct phase III clinical trial on a wider range of patients in 10 countries and further verify the safety and efficacy of Rekirona.

 

It plans to conduct phase III clinical trials in more than 10 countries around the world to further verify the safety and efficacy of Rekirona confirmed in phase II clinical trials in a wider range of patients.

 

A Celltrion official said, "We have already completed production for 100,000 people and are thoroughly preparing a supply plan so that we can supply them to the medical field as soon as we acquire CMA." He said, "We are systematically preparing a plan to produce treatments for up to 2 million people so that global supply will not be disrupted in accordance with the timing of approval in major overseas countries."