The Celltrion Group announced the launch of its Phase III clinical trial of CT-P59, a candidate anti-COVID-19 monoclonal antibody treatment as a preventive. The launch of the post-exposure prophylaxis clinical trial follows the approval of the Investigational New Drug Application (IND) by the Korean Ministry of Food Safety and Medicines on October 8, 2020.

Celltrion expects to recruit approximately 1,000 patients to assess prophylaxis for populations in contact with patients infected with SARS-CoV-2. The post-exposure prophylaxis clinical trial will assess the preventative effect and safety of CT-P59 and determine whether it can induce a neutralizing antibody response to block virus infection in human cells.

" We hope that anti-COVID-19 monoclonal antibodies like CT-P59 can offer people at high risk effective protection against COVID-19 and help prevent any further spread in the population," said Dr Sang Joon Lee, Senior Executive Vice President of Celltrion. " We look forward to continuing to generate data as this trial unfolds and we remain committed to fighting the spread of the virus around the world."

Celltrion has already shown promising safety results in Phase I clinical trial in healthy volunteers. The Korean Ministry of Food Safety and Medicines has now approved Celltrion's IND application to initiate a pivotal Phase II / III trial of this potential treatment in patients with mild to moderate symptoms.

Celltrion Healthcare is committed to providing innovative and affordable medicines to promote patient access to advanced therapies. Its products are manufactured in state-of-the-art mammalian cell culture sites, designed and manufactured in accordance with US FDA aGMP and EU GMP. Celltrion Healthcare strives to provide cost-effective and high-quality solutions through an extensive global network spanning over 110 countries.