Celltrion Group, a South Korean pharma company, has launched a phase 1 human clinical trial of a potential antiviral antibody treatment for COVID-19 patients.
The in-human study of the COVID-19 antiviral antibody comes in the wake of the positive results delivered by it in pre-clinical studies and the following approval of the investigational new drug application from the Korean Ministry of Food and Drug Safety (MFDS).
Celltrion said that the potential antiviral treatment will also be studied for use as a preventative measure.
The COVID-19 phase 1 clinical trial will look to enroll 32 healthy volunteers in partnership with Chungnam National University Hospital. The clinical trial will assess the safety of the antiviral antibody treatment candidate in healthy people who have not been diagnosed with the novel coronavirus.
The South Korean pharma company expects the early-stage COVID-19 trial to be completed by the third quarter of this year.
Celltrion will also carry out an additional in-human phase 1 clinical trial of the antiviral treatment candidate in mild COVID-19 patients in Europe, including the UK, following which, there will be global phase 2/3 trials in patients having mild and moderate COVID-19.
The South Korean biopharma company said that it expects promising preliminary results from pivotal studies by the end of 2020.
Additionally, Celltrion is planning to conduct a clinical trial for evaluating the use of the potential antiviral antibody treatment as a preventative measure, by taking in people in close contact with COVID-19 patients across the world. The topline data for this clinical trial is expected in the first quarter of 2021, said the company.
Dr. Sang Joon Lee – Senior Executive Vice President of Celltrion said: “The initiation of this in-human clinical trial is a key milestone in the development of our antiviral antibody treatment.
“We were encouraged by the positive safety and efficacy results in our pre-clinical studies, and we are now ready to move into in-human clinical trials as we originally planned. We remain committed to carrying out local and global clinical studies with the goal of commencing mass production of the therapeutic antibody treatment in the latter half of this year.”