South Korea’s Celltrion Group has reported interim results from the Phase I clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate.
The results showed a promising safety, tolerability and pharmacokinetics profile of CT-P59.
The Phase I clinical trial is a randomised, double blind and placebo-controlled trial designed to evaluate the safety, tolerability and pharmacokinetics of CT-P59 in healthy subjects.
The results demonstrated no significant drug-related adverse events (AEs), and importantly there were no adverse events from the maximum tolerated dose cohort.
“Along with these promising safety results, we have launched commercial production of CT-P59 this month to ensure, if trials are successful, we can meet the urgent global demand for a safe and effective antiviral treatment against COVID-19,” said Sang Joon Lee, Senior Executive Vice President of Celltrion.
“Should we receive positive results from our series of ongoing clinical trials, we intend to request emergency use authorisation for our drug.”
Celltrion has initiated an in-human, global, Phase I clinical trial of CT-P59 in mild COVID-19 patients and plans to conduct further global Phase II and III trials in 500 patients from 12 countries including Korea.
The company anticipates the enrolment of a total of 3,000 patients including those involved in the prevention clinical trial, investigating the use of CT-P59 as a preventative treatment for COVID-19 in those in close contact with COVID-19 patients.
The company anticipates the development of the anti-COVID-19 monoclonal antibody treatment candidate will be complete by the first half of 2021.