The pre-clinical in vivo study assessed the neutralization effect of CT-P59 against the Delta variant or B.1.617.2, the SARS-CoV-2 strain first identified in India, using a clinically relevant dose, according to the South Korean biopharma group.
The trial, said the firm, 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, confirmed the Incheon headquartered company.
“These new data are encouraging and reinforcing our body of both preclinical and clinical data,” said Dr HoUng Kim, head of medical and marketing division, Celltrion Healthcare.
Celltrion also announced its full Phase III data at the 31st European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) which took place online from July 9-12, 2021, with the developer reporting that the data showed CT-P59 significantly reduced the risk of COVID-19 related hospitalization or death by 72% for patients at high-risk of progressing to severe COVID-19 and 70% for all patients.
Regulatory pathway
The European Medicine Agency (EMA) started a rolling review of CT-P59 in February 2021 to evaluate clinical data. In March 2021, the EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive scientific opinion for the antibody, with it recommending that it could be considered a treatment option for patients at high risk of progressing to severe COVID-19, based on a reasonable likelihood that the medicine may provide clinical benefit, and a low likelihood of harm.
Moreover, in June 2021, the European Commission (EC) selected CT-P59 as one of the five treatments chosen for an initial portfolio of preferred drugs to treat COVID-19.
In terms of the regulatory status of the antibody in other territories, early February saw the South Korean Ministry of Food and Drug Safety (MFDS) grant a Conditional Marketing Authorization (CMA) for the emergency use of regdanvimab (CT-P59), making it the first monoclonal antibody treatment for COVID-19 to be approved in Korea.
On July 17, the Indonesian Food and Drug Authority approved regdanvimab for emergency use in that market.
Celltrion has also submitted requests for emergency use authorization (EUA) of the antibody in several other countries: Malaysia, India, Brazil, Mexico, Canada, Jordan, Saudi Arabia, UAE.
