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The Korean MFDS has given its approval for Celltrion to initiate a Phase II/III trial of its anti-COVID-19 monoclonal antibody treatment candidate, CT-P59.
The Korean Ministry of Food and Drug Safety (MFDS) has given its approval for Celltrion to initiate a Phase II/III trial of its anti-COVID-19 monoclonal antibody treatment candidate, CT-P59, following positive interim results from the Phase I trial.
According to a Sept. 17, 2020 press release, Celtrion had submitted an investigational new drug (IND) application for the clinical trial in six countries and has plans to enroll more than 1000 patients from up to 12 countries. The Phase II/III trial will assess the safety and efficacy to CT-P59 in patients with mild-to-moderate symptoms of SARS-CoV-2 infection.
“Given that COVID-19 represents a significant global threat to life, there is an urgent need to identify treatments that can help stabilize our response to the pandemic. The initiation of the global Phase II/III pivotal trial of CT-P59 is an important step forward, and together with the ongoing Phase I trial in patients with mild symptoms, Celltrion remains committed to investigating a potential anti-COVID-19 monoclonal antibody treatment,” said Dr. Sang Joon Lee, senior executive vice-president of Celltrion, in the press release.
The company has already begun manufacturing the process validation batch of its anti-COVID-19 treatment and has plans to increase manufacturing capacity to meet global and domestic demand.