Celltrion Receives Korean MFDS Approval to Initiate Phase I Trial of COVID-19 Antiviral Antibody Treatment Candidate, CT-P59, in Patients
- The Korean Ministry of Food and Drug Safety (MFDS) approved Celltrion’s Investigational New Drug (IND) application to initiate a Phase I trial of CT-P59 in patients
- By the end of the year Celltrion anticipates global pivotal study results from Phase II/III trials in patients with mild symptoms of COVID-19, the Phase III trial in moderate-to-severe patients, and the prevention trial
- As part of the prevention clinical trial, Celltrion will enrol those who are in close contact with COVID-19 patients and those with no symptoms to investigate the potential short-term preventative effects of CT-P59 against SARS-CoV-2 infection
INCHEON, South Korea: Celltrion Group has announced that the Korean Ministry of Food and Drug Safety (MFDS) has approved the company’s Investigational New Drug (IND) application for a Phase I clinical trial of CT-P59, a COVID-19 antiviral antibody treatment candidate. Celltrion has initiated enrolment of patients with mild symptoms of SARS-CoV-2 infection and the clinical trial is set to evaluate the safety, tolerability, efficacy, pharmacokinetics and immunogenicity of CT-P59.
Celltrion anticipates global pivotal study results from the Phase II and III trials in patients with mild symptoms, the Phase III trial in patients with moderate-to-severe COVID-19, and the prevention clinical trial, by the end of the year. Celltrion plans to enrol people that are in close contact with COVID-19 patients and those with no symptoms as part of a prevention clinical trial to evaluate whether CT-P59 can elicit a neutralising antibody response to prevent the virus from infecting human cells.
“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.” said Dr. Sang Joon Lee, Senior Executive Vice President of Celltrion. “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, Celltrion initiated a Phase I trial of CT-P59 in the UK following the approval of the clinical trial authorisation (CTA) application from the UK Medicines and Healthcare products Regulatory Agency (MHRA). Celltrion has also completed an infusion and initial safety assessment for the Phase I study in healthy volunteers in Korea and the study is set for completion by Q3 this year as originally planned.