October 12, 2020 -- Celltrion has launched a phase III clinical trial investigating CT-P59, an anti-COVID-19 monoclonal antibody (mAb) treatment candidate.
The trial begins following approval of the investigational new drug (IND) application by the Korean Ministry of Food and Drug Safety (MFDS) on October 8.
The company plans to enroll approximately 1,000 patients to evaluate population-based prophylaxis in SARS-CoV-2 infected patients. The post-exposure prophylaxis clinical trial will evaluate the preventative and safety potential of the candidate and whether it can elicit a neutralizing antibody response to prevent the virus from infecting human cells.
CT-P59 has shown promising results in a phase I clinical trial in healthy volunteers.