Celltrion Group has received approval from the Korean Ministry of Food and Drug Safety (MFDS) to conduct a Phase I clinical trial of its antiviral antibody treatment candidate, CT-P59, against Covid-19.
Celltrion has commenced enrolment of patients with mild symptoms of the disease.
The company discovered CT-P59 as a potential Covid-19 treatment after screening antibody candidates and selecting those with highest potency in neutralising the SARS-CoV-2 virus, including the mutated G-variant strain (D614G variant).
In pre-clinical testing, the drug candidate led to a 100-fold decrease in the viral load of SARS-CoV-2 and also reduced lung inflammation.
The Phase I study is designed to assess the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of CT-P59.
Celltrion expects to obtain data from the Phase II and III trials in patients with mild symptoms, the Phase III trial for moderate-to-severe CovidD-19 and the prevention trial, by the end of the year.
For the prevention trial, the company will enrol people who are in close contact with Covid-19 patients and those with no symptoms to investigate if CT-P59 can trigger a neutralising antibody response to prevent the infection.
Celltrion senior executive vice-president Dr Sang Joon Lee said: “We have initiated an in-human global Phase I clinical trial of CT-P59 in mild Covid-19 patients and we plan to conduct further global Phase II and III trials in this patient group.
“In addition, Celltrion plans to combine Phase II and III trials in patients with moderate-to-severe Covid-19 with the prevention clinical trials.
“We are extremely encouraged by the consistent progress we are making in preparation for our CT-P59 clinical trials in various settings, and we remain on track to reach our upcoming milestones.”
In July, the company launched a Phase I trial of CT-P59 in the UK after approval from the Medicines and Healthcare products Regulatory Agency (MHRA).
The company also completed an infusion and initial safety evaluation in the Phase I trial in healthy volunteers in Korea.