On July 17, South Korea’s Celltrion Group announced the launch of its Phase I human clinical trial investigation of a potential antiviral antibody treatment for patients with COVID-19. Celltrion hopes to complete Phase I by the fall, with additional human studies planned across Europe by the end of the year.
Celltrion is a biopharmaceutical company headquartered in Incheon, South Korea. It was founded in 2002 and has gradually expanded its distribution channels over the past 18 years to include America, Europe, Japan, and the Middle East.
The FDA has approved multiple Celltrion drugs for use in the United States already, including Inflectra for rheumatoid arthritis, Crohn’s disease and psoriasis, and Truxima for Non-Hodgkin’s Lymphoma and Chronic Lymphocytic Leukemia. Both drugs are monoclonal antibodies designed to slow the progression of disease.
Celltrion is now leveraging its past experience and success with antibodies to join the race for an effective COVID-19 treatment.
What Is Celltrion’s COVID-19 Antiviral Antibody Treatment?
At the end of May, Celltrion announced positive pre-clinical results for its COVID-19 antiviral antibody treatment, though the name of the treatment hasn’t yet been publicly announced. The pre-clinical trial sought to assess the efficacy of two dosage amounts (low and high) for Celltrion’s experimental treatment.
When compared to a placebo-controlled group, pre-clinical data demonstrated a 100-fold reduction in the viral load of SARS-CoV-2 and improvement in lung lesions in animal models. Just as importantly, the research team observed improved recovery from COVID-19 symptoms and clinical remission after the fifth day of treatment.
All About Celltrion’s Phase I Clinical Trial
The Phase I clinical trial for Celltrion’s experimental antiviral antibody treatment aims to enroll 32 healthy volunteers in collaboration with Chungnam National University Hospital in South Korea. According to Celltrion, “The study will evaluate the safety of the antiviral antibody treatment candidate in healthy participants who have not been diagnosed with COVID-19.”
Another in-human Phase I clinical trial is set to take place across Europe using patients with mild cases of COVID-19. Celltrion plans to follow this up with global Phase II/III trials in patients with mild and moderate COVID-19.
“The initiation of this in-human clinical trial is a key milestone in the development of our antiviral antibody treatment,” said Dr. Sang Joon Lee, Senior Executive Vice President of Celltrion. “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.