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June 15, 2021

Celltrion’s Covid-19 drug regdanvimab meets Phase III endpoints

Regdanvimab met the primary efficacy goal of a significant decrease in the risk of hospitalisation or death.

South Korea-based Celltrion Group has reported positive top-line results from the Phase III clinical trial of its monoclonal antibody candidate, regdanvimab (CT-P59), to treat mild-to-moderate Covid-19 symptoms.

The drug candidate met all primary and key secondary goals during the study.

Regdanvimab met the primary efficacy endpoint of a significant decrease in the risk of hospitalisation or death. It reduced the risk by 72% in patients who were at high risk of disease progression up to day 28 versus placebo.

The candidate also met the first key secondary goal with a significant reduction in the risk of hospitalisation or death by 70% in all patients.

Other key secondary endpoints, which include quicker and sustained lowering of symptom duration, were also met.

Compared to participants who received a placebo, those treated with 40mg/kg regdanvimab experienced recovery a minimum of 4.7 days earlier.

The medium recovery was 9.3 days in the treatment arm, compared to a minimum of 14 days in the placebo arm. This data was obtained from subjects at high risk of advancing to severe Covid-19.

In all subjects treated with the drug candidate, the recovery was 4.9 days earlier, with a median of 8.4 days versus 13.3 days on placebo.

According to the top-line data, regdanvimab demonstrated a positive safety profile, without any clinically meaningful differences between participants who received the treatment and those on placebo.

The company noted that infusion-related reactions were mild and transient, and the majority of patients recovered in one to three days.

Celltrion Healthcare Medical and Marketing division head Dr HoUng Kim said: “As many hospitals across the globe now exceed their ability to accommodate patients due to Covid-19, it is critical that we use every resource to reduce the burden on the healthcare system.

“This well-controlled trial provides conclusive results demonstrating that CT-P59 can improve outcomes in people with mild- to-moderate COVID-19 and also significantly reduce the risk of hospitalisation and death.”

Findings from in vivo ferret challenge studies showed that a therapeutic dosage of the drug candidate reduced the viral load of the B.1.351 SARS-CoV-2 variant in the upper and lower respiratory tracts.

This is similar to the findings for the wild-type virus. B.1.351 was first identified in South Africa.

Last month, Celltrion reported regdanvimab’s neutralising potency against SARS-CoV-2 variants first detected in New York, US (B.1.526), Nigeria (B.1.525), and India (B.1.617).

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