25 November 2020 - - Enrolment of 327 patients with mild-to-moderate symptoms of SARS-CoV-2 infection has completed in the global Phase II clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate, South Korea-based Celltrion Group said.

Celltrion said it anticipates submission for emergency use authorisation to the Korean Ministry of Food and Drug Safety, conditional on results from the global Phase II pivotal trial.

The global Phase II clinical trial is a randomised, double-blind, placebo-controlled and parallel-group trial designed to evaluate the efficacy and safety of CT-P59 in combination with standard of care in patients with SARS-CoV-2 infection.

The trial enrolled 327 patients with mild-to-moderate symptoms of COVID-19 across three groups (placebo, low concentration, high concentration) and Celltrion is set to obtain the results for global Phase II trial.

In addition, Celltrion plans to initiate a global Phase III clinical trial in more than 10 countries in order to obtain more comprehensive safety and efficacy results of CT-P59.

In an effort to further address the pandemic, Celltrion has also initiated a post-exposure prophylaxis clinical trial to evaluate the preventive effect and safety of CT-P59 and identify whether this antibody treatment candidate can elicit a neutralising antibody response to prevent the virus from infecting human cells.

Celltrion is also working to increase its manufacturing capabilities to meet the current global and domestic demand for the anti-COVID-19 monoclonal antibody treatment candidate, ensuring potential delivery for as many as 2m people per year globally.

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

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

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.