[Photo provided by Celltrion Inc.]
South Korea’s Celltrion Inc. has completed in-human Phase 1 clinical trial of CT-P59, a COVID-19 antiviral antibody treatment candidate. It plans to begin commercial production soon to supply the antibody drug immediately when it secures additional evidence of efficacy and safety.
The biotech firm said Friday that it has completed the Phase 1 study, verifying safety, tolerability and pharmacokinetic properties of CT-P59 COVID-19 antibody drug candidate. The Phase I trial involved 32 healthy volunteers in Korea. It is currently conducting separate human trials in patients with mild symptoms of SARS-CoV-2 infection.
Its stock ended Friday flat at 298,500 won ($251.43).
The company plans to launch Phase 2 and 3 trials, involving COVID-19 patients outside Korea when it gathers results from Phase 1 study in mild-symptom patients. It already has filed for regulatory reviews in seven countries including Korea, with an aim to conduct trials in 500 or more COVID-19 patients at up to 12 countries and get mid-term results by the end of this year. It also plans to conduct trial of the antibody drug in people who had close contact with COVID-19 patients.
Celltrion expects to start supplying the COVID-19 antibody treatment to the public in the first half of next year. It said it will begin production of the candidate drug this month for process validation to roll it out immediately after the final testing.
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