[Photo provided by Celltrion Inc.]
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.
Celltrion shares ended flat at 291,500 won ($251.18) on Friday.
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.
Celltrion is planning to submit IND for Phase 2 and 3 trials in five European countries this week, said Lee Sang-joon, senior vice president of Celltrion.
The company is also reviewing an option to file for emergency authorization if positive results come from a Phase 2 trial to ensure early commercial supply. It already decided to make inventory and production adjustments to meet potential demand for mass production of the COVID-19 cure.
Celltrion also plans to conduct trials to evaluate whether the antibody therapy can prevent coronavirus infection in asymptomatic patients and those who were in close contact with diagnosed individuals.
By Kim Si-gyun and Minu Kim
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