The Medicines and Healthcare products Regulatory Agency (MHRA) has issued a green light for a Phase I trial assessing Celltrion's potential COVID-19 treatment CT-P59.
The trial is designed to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of the antiviral antibody treatment.
Celltrion says it plans to conduct further global Phase II/III trials in patients with mild and moderate COVID-19 and anticipates results from these pivotal studies by the end of the year.
A clinical trial investigating CT-P59 in the preventative setting, by enrolling people in close contact with COVID-19 patients globally, is also planned with top-line data expected in the first quarter of next year.
“This is a timely approval from the UK regulatory authority for the Phase I clinical trial with CT-P59 as the global pandemic continues to grow and there remains a significant need for a safe and effective treatment for COVID-19,” said Dr Sang Joon Lee, senior executive VP of Celltrion.
“We are rapidly advancing our COVID-19 programme with CT-P59, including a Phase I clinical trial in healthy volunteers in Korea. Furthermore, we are making efforts to ensure that if the clinical trial programme is successful we are able to scale up manufacturing appropriately.”
Celltrion said it is due to start full-scale commercial production of CT-P59 in September this year, and that it will secure manufacturing capacity to produce enough of the treatment for up to 5 million patients a year.