13 January 2021 - - South Korea-based pharmaceutical company Celltrion Group has released top-line results from its randomised, double-blind, and placebo controlled global Phase II/III clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate.

The Part I of the trial enrolled 327 patients with mild-to-moderate symptoms of COVID-19 across three treatment groups (40mg/kg, 80mg/kg and placebo), in which approximately 60% of patients with moderate symptoms suffered from COVID-19 related pneumonia.

This data analysis has demonstrated that at Day 28, CT-P59 treated patients presented with a significantly reduced risk of COVID-19 related hospitalisation and oxygenation without mortality.

When compared to placebo, CT-P59 (40mg/kg) treated patients reported reduced progression rates to severe COVID-19 by 54% for mild-to-moderate patients and 68% for moderate patients aged 50 years and over.

CT-P59 treatment groups also reported with significantly shortened time to clinical recovery ranging from 3.4 to 6.4 days quicker compared to placebo.

Patients treated with CT-P59 (40mg/kg) recovered 3.4 days earlier than those in the placebo group [5.4 vs. 8.8 days; 95% C.I, 5.35(3.97, 6.78) to 8.77 (6.72, 11.73), log-rank p-value= 0.0097]. Patients with pneumonia treated with CT-P59 (40mg/kg) reported shortened recovery time by 5.1 days compared to placebo [5.7 vs. 10.8 days; 95% C.I, 5.73 (4.13, 7.33) to 10.81 (6.81, N.C.)].

Moderate patients aged 50 years and over treated with CT-P59 (40mg/kg) reported a shortened recovery time by 6.4 days compared to placebo [6.6 vs. 13.0 days; 95% C.I, 6.64 (4.13, 11.94) to 12.97 (6.81, N.C.)].

In addition, CT-P59 treated patients rapidly and significantly reduced viral load through Day 7 compared to placebo.

Top-line results from the trial shows CT-P59 to have a positive safety profile, comparable to that of the placebo group, with no serious adverse advents reported.

Infusion related reactions were mild and transient, with the CT-P59 treatment group having reported 0.5%, compared to 1.8% reported with placebo.

Nature Communications has published the preclinical data of CT-P59 against SARS-CoV-2, demonstrating a 100-fold reduction in the viral load of SARS-CoV-2 and improved recovery time in animal models.

Additionally, the data showed encouraging results meeting several criteria from its studies; in-vitro plaque reduction neutralization test against SARS-CoV-2 and SARS-CoV-2 D614G variant to assess the neutralization potency of CT-P59, in-vivo efficacy in animal models to demonstrate in vivo antiviral efficacy of CT-P59, as well as in vitro antibody-dependent enhancement assay to investigate the possible adverse effects of a COVID-19 treatment.

Celltrion Healthcare aims to offer 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.

The company has 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.

Results from the global Phase I clinical trial of CT-P59 demonstrated promising safety, tolerability, antiviral effect and efficacy profile in patients with mild symptoms of COVID-19.