Celltrion launches human clinical trials of potential COVID-19 antibody treatment
South Korean biopharma giant Celltrion said on July 24 it has launched phase 1 clinical trials of a potential antiviral antibody treatment for COVID-19 patients.
The clinical study follows promising preclinical results for the virus treatment candidate and has received approval from the Korean Ministry of Food and Drug Safety.
Celltrion headquarters in Songdo, Incheon (Celltrion)
In collaboration with Chungnam National University Hospital, the phase 1 trials will include 32 patients. The study, which is expected to complete by the third quarter of this year, will evaluate the safety of the antiviral antibody treatment candidate.
Another set of phase 1 clinical trials are set to be conducted among mild COVID-19 patients across Europe, followed by global phase 2 and 3 trials with mild and moderate COVID-19 patients. Celltrion expects preliminary results by the end of the year.
Another clinical study will be conducted with people who physically contacted COVID-19 patients globally to investigate the validity of the potential antiviral antibody treatment and preventative measure. The topline data for this trial is anticipated in the first quarter of next year.
“The initiation of this clinical test is a key milestone in the development of our antiviral antibody treatment,” said Dr. Lee Sang-joon, vice president of Celltrion.
“We are now ready to move into in-human clinical trials. We will carry 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.”
Previously, Celltrion demonstrated its antiviral antibody treatment to be effective in neutralizing the mutated G-variant strain of D614G variant, which is associated with the increased viral transmission and widespread of COVID-19.
By Jie Ye-eun (firstname.lastname@example.org)