November 6, 2020 8:13:34 am
South Korean drugmaker Celltrion Inc said on Friday patients treated with its experimental COVID-19 antibody drug in a small-size early-stage trial showed at least a 44% improvement in recovery time.
The result bodes well for Celltrion, which plans to seek conditional approval for the monoclonal antibody treatment, CT-P59, for emergency use by the end of this year in South Korea.
In its global Phase 1 trial that enrolled 18 patients with mild symptoms of COVID-19, 15 participants who received the treatment had a mean recovery time about 44% faster than three people in a placebo group.No patients treated with CT-P59 in the study had so far required hospitalisation or other antiviral therapy as a result of COVID-19, and the treatment was well tolerated with no clinically significant safety issues, it said.
Celltrion, which is planning global Phase 2 and 3 trials of the drug, said last month it received regulatory approval for Phase 3 clinical trials from South Korea.
The third-stage trials will be conducted on about 1,000 asymptomatic coronavirus patients and those who have come into close contact with COVID-19 patients in Korea.
The treatment, the most advanced antibody drug in terms of research in South Korea, is directed against the surface of the coronavirus and designed to block it from locking on to human cells.
Celltrion began commercial production of the drug in September, which is likely to amount to around 1 million doses, in anticipation of demand in both domestic and overseas markets.
Monoclonal antibodies are manufactured copies of antibodies created by the body to fight infection.
Developers of COVID-19 antibody treatments include U.S. firms Eli Lilly and Regeneron, Roche, and Novartis.No monoclonal antibody has been approved against COVID-19 so far.
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