Therapy Areas: Inflammatory Diseases
Celltrion's Monoclonal Antibody Treatment for COVID-19 Demonstrates Strong Neutralising Activity Against Delta Variant
16 July 2021 - - South Korea-based Celltrion Group has released new results from an in vivo efficacy study showing that regdanvimab (CT-P59) has a strong neutralising effect against the rapidly spreading Delta variant (B.1.617.2, first identified in India), the company said.

According to the World Health Organization, the Delta variant has been reported in 96 countries becoming the most common variant.

The pre- clinical in vivo study assessed the neutralisation effect of CT-P59 against the Delta variant, using a clinically relevant dose.

The study demonstrated that CT-P59 treatment results in a 100% survival rate from COVID-19 compared to 0% for the placebo group, with significant protection against body weight loss shown after viral challenge also seen.

In addition, a therapeutic dosage of CT-P59 significantly reduced the viral load of SARS-CoV-2 and inflammation in the lungs compared to non-treated controls with virus eradication from all animals treated with CT-P59.

Taken together, CT-P59 has shown in vivo efficacy against Delta variant following Beta (B.1.351, first identified in South Africa) and Gamma variant (P.1, first identified in Brazil), which was comparable to that against wild type SARS-CoV-2, thus demonstrating that despite the reduced in vitro neutralising activity against Variants of Concern, CT-P59 retained its therapeutic potency in in vivo setting.

The monoclonal antibody CT-P59 also demonstrated strong neutralising capability against the Lambda variant (C.37, first identified in Peru) in a cell-based pseudo- virus assay study performed by the National Institutes of Health, US.

Celltrion announced its full Phase III data at the 31st European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) which took place online from 9 -12 July 2021.

During the oral session, data showed regdanvimab (CT-P59) significantly reduced the risk of COVID-19 related hospitalisation or death by 72% for patients at high- risk of progressing to severe COVID-19 and 70% for all patients.

In addition, patients who were treated with regdanvimab (CT-P59) reported a significantly shortened time to clinical recovery by at least 4.7 days for patients at high- risk of progressing to severe COVID-19 and by 4.9 days compared to placebo for all 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 high-quality cost-effective solutions through an extensive 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. 

In vitro and in vivo pre- clinical studies showed that CT-P59 strongly binds to SARS-CoV-2 RBD and significantly neutralise the wild type and mutant variants of concern including the Alpha variant (B.1.1.7, first identified in the UK).

In in vivo models, CT-P59 effectively reduced the viral load of SARS-CoV-2 and inflammation in lung. Results from the global Phase I and II clinical trials of CT-P59 demonstrated a promising safety, tolerability, antiviral effect and efficacy profile in patients with mild- to- moderate symptoms of COVID-19.4 Celltrion also has recently commenced the development of a neutralising antibody cocktail with CT-P59 against new emerging variants of SARS-CoV-2.
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