23 July 2020 | News
Celltrion’s COVID-19 antiviral antibody treatment candidate has been proven to be effective in neutralizing different kinds of coronavirus related strains including the mutated G-variant strain of SARS-CoV-2 (D614G variant)
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South Korea based Celltrion Group has announced the launch of its Phase I human clinical trial investigating a potential antiviral antibody (Ab) treatment for patients with COVID-19. The in-human study follows positive pre-clinical results for the treatment candidate and subsequent approval of the Investigational New Drug application by the Korean Ministry of Food and Drug Safety (MFDS). The potential treatment will also be investigated for use as a preventative measure.
The Phase I clinical trial aims to enroll 32 healthy volunteers in collaboration with Chungnam National University Hospital. The study will evaluate the safety of the antiviral antibody treatment candidate in healthy participants who have not been diagnosed with COVID-19. The trial’s completion is expected by Q3 of this year.
Celltrion is set to conduct a further in-human Phase I clinical trial of the antiviral treatment candidate in mild COVID-19 patients across Europe, including the UK, which will be followed by global Phase II/III trials in patients with mild and moderate COVID-19. Celltrion anticipates promising preliminary results from pivotal studies by the end of the year.
In addition, a clinical trial investigating the use of the potential antiviral antibody treatment as a preventative measure, by enrolling people in close contact with COVID-19 patients globally, is also planned. The topline data for this trial is anticipated in Q1 of 2021.
Furthermore, Celltrion has previously demonstrated its antiviral antibody treatment to be effective in neutralizing the mutated G-variant strain (D614G variant), which is associated with the increased viral transmission and widespread of COVID-19.