Celltrion Group has announced that CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate, has confirmed neutralising potency against emerging virus mutations and that the company has initiated development of a neutralising antibody cocktail treatment with CT-P59.

The Korea Disease Control and Prevention Agency (KDCA) has assessed and independently confirmed that CT-P59 successfully neutralises the SARS-CoV-2 variants first identified in the UK (B.1.1.7) in addition to the previously identified six variant genome mutations of SARS-CoV-2 (variants S·L·V·G·GH·GR). They also added that cocktail therapy of CT-P59 with another monoclonal antibody candidate demonstrated neutralising capability against the UK (B.1.1.7) and South African (B.1.351) variants.

In order to elicit potent neutralising antibodies against the new emerging variants and to minimise lead time for introducing cocktail treatments with CT-P59, Celltrion previously captured a total of 38 potent neutralising antibodies against SARS-CoV-2 in which antibody candidate No 32 produced neutralising titres against new emerging strains in the UK and South Africa.

To date, CT-P59 has been shown to significantly reduce the risk of COVID-19 related hospitalisation and oxygenation up to day 28, reduce rate of progression to severe COVID-19 by 54 per cent for patients with mild-to-moderate symptoms and 68 per cent for moderate patients aged 50 years and over, and significantly shorten the time to clinical recovery ranging from 3.4 to 6.4 days quicker compared to placebo. A global Phase III clinical trial is currently recruiting and is expected to enroll 1,172 patients with mild-to-moderate symptoms of COVID-19 at more than 10 global sites to evaluate the efficacy and safety of CT-P59.

Adrian Streinu-Cercel, Global Principal Investigator, Professor, Infectious Diseases, Carol Davila University of Medicine and Pharmacy, Bucharest, Romania, said, “CT-P59 has demonstrated its ability to shorten time to clinical recovery and reduce rate of progression to severe COVID-19. From the clinical trial, one of my patients with COVID-19 aged 85 and with an underlying condition, has recovered from the virus within 48 hours of being treated with CT-P59. The antibody treatment candidate would be most useful within 3-5 days of testing positive for the virus. This will greatly aid efforts to address the current burden on healthcare systems and resources.”