13 October 2020 - - South Korea-based Celltrion Group hs launched of its Phase III clinical trial investigating CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate as a preventative measure, the company said.

The initiation of the post-exposure prophylaxis clinical trial follows the approval of the Investigational New Drug application by the Korean Ministry of Food and Drug Safety on October 8th, 2020.

Celltrion anticipates the enrolment of approximately 1,000 patients to evaluate population-based prophylaxis in contacts of SARS-CoV-2 infected patients.

The post-exposure prophylaxis clinical trial will evaluate the preventive effect and safety of CT-P59 and whether CT-P59 can elicit a neutralising antibody response to prevent the virus from infecting human cells.

Celltrion has previously shown promising safety results in the Phase I clinical trial in healthy volunteers. The MFDS has now approved Celltrion's IND application to initiate a Phase II/III pivotal trial of this potential treatment in mild-to-moderate patients.

Celltrion Healthcare is committed to delivering innovative and affordable medications to promote patients' access to advanced therapies.

Its products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US FDA cGMP and the EU GMP guidelines.

Celltrion Healthcare endeavours to offer cost-effective solutions through a global network that spans more than 110 different countries.

CT-P59 was identified as a potential treatment for COVID-19 through screening of antibody candidates and selecting those that showed the highest potency in neutralising the SARS-CoV-2 virus including the mutated G-variant strain (D614G variant).

In pre-clinical data the treatment candidate demonstrated a 100-fold reduction in viral load of SARS-CoV-2, as well as a reduction in lung inflammation.