KUALA LUMPUR, June 14 (Bernama) -- Celltrion Group has announced top-line efficacy and safety data from the global Phase III clinical trial, demonstrating that anti-COVID-19 monoclonal antibody treatment candidate, regdanvimab (CT-P59), met all primary and key secondary endpoints in patients with mild- to- moderate symptoms of COVID-19 (n=1,315).
Results showed that CT-P59 significantly reduced the risk of hospitalisation or death by 72 per cent for patients at high risk of progressing to severe COVID-19 up to Day 28, compared to placebo, meeting the primary efficacy endpoint.
Head of Medical and Marketing Division at Celltrion Healthcare, Dr HoUng Kim, Ph.D. said: “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.”
According to a statement, CT-P59 also significantly reduced the risk of hospitalisation or death by 70 per cent 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.
Top-line results also showed CT-P59 to have a positive safety profile, with no clinically meaningful differences between patients treated with CT-P59 (40mg/kg) and placebo-treated patients.
Celltrion plans to release full Phase III data in the coming months and plans to present the data at an oral session at the 31st European Congress of Clinical Microbiology & Infectious Diseases (ECCMID), which will take place online from July 9-12.
More details at https://www.celltrionhealthcare.com/en-us.
-- BERNAMA
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