Tony Hagen is senior managing editor for The Center for Biosimilars®.
Celltrion Healthcare said an antiviral drug candidate is moving along in trials as a potential treatment for coronavirus 2019 (COVID-19).
Although it has an infliximab biosimilar being tested in the CATALYST trial for potential use in patients with coronavirus disease 2019 (COVID-19), Celltrion Healthcare said today it has an antiviral antibody treatment candidate in a phase 1 study for patients with COVID-19 and that is expected to be completed by the end of the third quarter of this year.
The COVID-19 drug candidate treatment has shown promise in neutralizing several coronavirus-related strains, including the mutated G-variant strain of severe acute respiratory syndrome coronavirus 2 (D614G variant), the company said in a statement. Further in-human studies across Europe are planned.
The phase 1 study follows a new drug application approval from the Republic of Korea Ministry of Food and Drug Safety. Celltrion officials also said they expect the agent will be tested as a form of preventive therapy for COVID-19.
The phase 1 trial will enroll 32 healthy volunteers who have not had a COVID-19 diagnosis and evaluate safety of the antiviral antibody treatment. Following a further in-human phase 1 trial in Europe, Celltrion anticipates expanding the investigation through phase 2/3 trials in patients with mild and moderate COVID-19.
Additional investigation is planned in use of the antiviral as a preventive measure in individuals who come into proximity with patients with COVID-19, such as health care workers.
“The initiation of this in-human clinical trial is a key milestone in the development of our antiviral antibody treatment,” said Sang Joon Lee, PhD, senior executive vice president of Celltrion. “We were encouraged by the positive safety and efficacy results in our preclinical 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.”