Korea's Celltrion Group on 5 Nov 2020 announced results from the ongoing Phase I clinical trial of CT-P59, an anti-COVID-19 monoclonal antibody treatment candidate. The data presented at the 2020 fall Conference of the Korean Society of Infectious Diseases on 5th November 2020, demonstrated promising safety, tolerability, antiviral effect, and efficacy profile of CT-P59 in patients with mild symptoms of COVID-19.

The global Phase I clinical trial is a randomised, double-blind, placebo-controlled and parallel-group trial designed to evaluate the safety, tolerability and antiviral effect of CT-P59. The trial enrolled 18 patients with mild symptoms of SARS-COV-2 infection who were randomised into three cohorts in which 15 patients received CT-P59 at 20mg/kg, 40mg/kg or 80mg/kg respectively, or matching placebo (3 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 hospitalisation 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.

“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 II/III studies building on the positive results seen in this study.”

Celltrion has previously submitted the Investigational New Drug (IND) application for the clinical trial globally, and plans to conduct further global Phase II and III 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.