Celltrion begins Covid-19 human clinical trial with antiviral antibody treatment

Celltrion Group has commenced phase 1 human clinical study to assess the potential of its antiviral antibody treatment for patients with Covid-19.

The in-human study follows positive pre-clinical results for the treatment candidate, as well as successive approval of the investigational new drug application by the Korean Ministry of Food and Drug Safety (MFDS). Celltrion will also evaluate the potential treatment for use as a preventative measure.

Celltrion, along with Chungnam National University Hospital, will recruit up to 32 healthy volunteers in phase 1 clinical study.

The trial will assess the safety of the antiviral antibody treatment candidate in healthy participants who were not been diagnosed with Covid-19. Celltrion is planning to complete the trial by the end of the third quarter this year.

The company is also planning to carry out a further in-human phase I clinical trial of the antiviral treatment candidate in mild Covid-19 patients across Europe, including the UK. It will be followed by global Phase II/III trials in patients with mild and moderate Covid-19.

Celltrion is planning to reveal the significant preliminary results from pivotal studies by the end of this year.

The company is also planning a clinical trial to evaluate the use of the potential antiviral antibody treatment as a preventative measure. It will recruit people in close contact with Covid-19 patients across the globe. The top-line data from this trial is expected to be revealed in the first quarter of 2021.

Celltrion stated that it has earlier showed its antiviral antibody treatment to be effective in neutralising the mutated G-variant strain that is associated with the increased viral transmission and widespread of Covid-19.

Celltrion senior executive vice president Dr. Sang Joon Lee said: “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.”