Korean Firm Celltrion’s Anti-COVID-19 Monoclonal Antibody Treatment Kills SARS-CoV-2 Virus Within 4-5 Days

Celltrion Group’s (Incheon, Korea) COVID-19 monoclonal antibody treatment candidate demonstrated promising safety, tolerability, antiviral effect, and efficacy in patients with mild symptoms of COVID-19 in Phase 1 clinical trial.

Celltrion has announced results from the ongoing Phase 1 randomized, double-blind, placebo-controlled and parallel-group trial designed to evaluate the safety, tolerability and antiviral effect of CT-P59, its anti-COVID-19 monoclonal antibody treatment candidate. The trial enrolled 18 patients with mild symptoms of SARS-COV-2 infection who were randomized into three cohorts in which 15 patients received CT-P59 at 20mg/kg, 40mg/kg or 80mg/kg respectively, or matching placebo (three patients). The results indicate that the patient population treated with CT-P59 experienced about 44% reduced mean clinical recovery time in comparison to the average placebo recovery time. None of the patients treated with CT-P59 required hospitalization or antiviral therapy as a result of COVID-19. No significant treatment-emergent serious adverse events or clinically significant treatment-emergent adverse events were identified at the interim stage.

Celltrion has previously submitted the Investigational New Drug (IND) application for the clinical trial globally, and plans to conduct further global Phase 2 and 3 trials, including Korea. In addition, Celltrion has also initiated a post-exposure prophylaxis clinical trial of CT-P59 to evaluate the candidate as a protective treatment, by investigating the efficacy of the treatment in those who have been in contact with confirmed SARS-CoV-2 infected patients.

“Past clinical trial results showed that coronavirus nearly dies within 4-5 days,” said Celltrion Group Chairman Seo Jung-jin in a radio interview. “(The treatment) gets rid of possibilities of developing severe symptoms or causing damage to internal organs. If the phase two trial is completed within this year and presents no side effect, (the company) will apply for a conditional approval in December to treat patients at an earlier date.”

“This is positive and encouraging efficacy and safety data showing accelerated recovery time in patients with mild symptoms of COVID-19,” said Professor Jin Yong Kim, Division of Infectious Diseases, Department of Internal Medicine, Incheon Medical Centre. “I look forward to the possibility of further promising data from ongoing Phase 2/3 studies building on the positive results seen in this study.”

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