South Korea’s Celltrion Inc. has been cleared to proceed with Phase 2 and 3 clinical trials of COVID-19 antibody treatment CT-P59 at home after the Ministry of Food and Drug Safety Thursday confirmed the safety and tolerability of the drug in a Phase 1 study.
The company’s Investigational New Drug (IND) application aims to evaluate the efficacy and safety of the genetic recombinant antibody therapy in Korean patients with mild to severe symptoms after coronavirus infection.
In Phase 2 and 3 studies, CT-P59 will be tested at some 10 hospitals including National Medical Center by the end of this year. The Phase 2 study involving 300 subjects will explore an appropriate dosage and therapeutic effects to treat COVID-19 symptoms. Once the dosage is determined, a confirmatory Phase 3 study will follow in 720 subjects.
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