Experimental COVID antibody treatment successful in trials

pharmafile | June 14, 2021 | News story | Sales and Marketing COVID-19, antibody therapy, celltrion, phase III 

Celltrion has announced positive top-line data for its experimental antibody COVID-19 treatment, with Phase III trials finding it safe and effective, reducing treatment periods by up to five days.

Regdanvimab (CT-P59) is an anti-COVID-19 monoclonal antibody treatment that, at a clinically relevant dose, results in a significant reduction in viral load of SARS-CoV-2.

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 receptor binding domain (RBD) and significantly neutralise the wild type and mutant variants of concern, including the Alpha and Beta variants.

The Phase III study enrolled 1,315 people across 13 countries including South Korea, the United States, Spain, and Romania.

Top-line results from the study showed that CT-P59 significantly reduced the risk of hospitalisation or death by 72% for patients at high-risk of progressing to severe COVID-19 up to day 28, compared to placebo, meeting the primary efficacy endpoint. CT-P59 also significantly reduced the risk of hospitalisation or death by 70% in all patients, meeting the first key secondary endpoint.

The trial also met the other key secondary endpoints, including faster and persistent reduction in symptom duration. Patients treated with CT-P59 (40mg) recovered at least 4.7 days earlier than those in the placebo-treated patients for patients at high- risk of progressing to severe COVID-19. For all patients treated with CT-P59 (40mg), patients recovered 4.9 days earlier than those in the placebo-treated patients.

Dr HoUng Kim, Head of Medical and Marketing Division at Celltrion Healthcare, said: “As many hospitals across the globe now exceed their ability to accommodate patients due to COVID-19, it is critical that we use every resource to reduce the burden on the healthcare system.

“This well-controlled trial provides conclusive results demonstrating that CT-P59 can improve outcomes in people with mild-to-moderate COVID-19 and also significantly reduce the risk of hospitalisation and death. We look forward to continuing to work with regulators around the world to make CT-P59 available to more patients in need.”

In February South Korea, where Celltrion is based, granted conditional approval to the antibody treatment, making it the first locally made coronavirus treatment in the country to win such approval.

Celltrion plans to release full Phase III data in the coming months and plans to present the data at an oral session at the upcoming European Congress of Clinical Microbiology & Infectious Diseases.

Kat Jenkins

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