Celltrion announces positive top-line results from COVID-19 treatment trial
pharmafile | January 14, 2021 | News story | | COVID-19, celltrion
Celltrion Group has announced that top-line results from its global Phase II/III clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate, show the drug significantly reduced the risk of coronavirus-related hospitalisation and oxygenation.
Part one of the randomised, double-blind, and placebo-controlled trial enrolled 327 patients with mild-to-moderate symptoms of COVID-19 across three treatment groups, in which approximately 60% of patients with moderate symptoms suffered from coronavirus-related pneumonia.
Data from the study has demonstrated that at day 28, CT-P59 treated patients presented with a significantly reduced risk of COVID-19-related hospitalisation and oxygenation without mortality. When compared to placebo, CT-P59 (40mg/kg) treated patients reported reduced progression rates to severe COVID-19 by 54% for mild-to-moderate patients, and 68% for moderate patients aged 50 years and over.
Patients treated with CT-P59 (40mg/kg) also recovered 3.4 days earlier than those in the placebo group, and patients with pneumonia treated with CT-P59 (40mg/kg) reported shortened recovery time by 5.1 days compared to placebo. Additionally, moderate patients aged 50 years and over treated with CT-P59 (40mg/kg) reported a shortened recovery time by 6.4 days compared to placebo.
Dr HoUng Kim, Head of Medical and Marketing Division at Celltrion Healthcare, said: “Our top-line data from the global Phase II/III clinical trial have demonstrated that CT-P59 is effective for the treatment of COVID-19 in mild-to-moderate patients and especially in moderate patients aged 50 years and over. We are encouraged by the robust and consistent nature of the top-line clinical profile of CT-P59 and our clinical studies are on track in more than 10 countries.
“We are planning to manufacture doses for around two million patients in 2021 and hope to improve access to this treatment option for those that require.”
Darcy Jimenez
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