Celltrion presents positive Phase I trial results for potential treatment candidate CT-P59 in patients with mild symptoms of COVID-19

Celltrion presents positive Phase I trial results for potential treatment candidate CT-P59 in patients with mild symptoms of COVID-19

·          Trial results indicate treatment with CT-P59 resulted in at least 44% faster recovery time when compared with placebo

·          None of the patients treated with CT-P59 in the study have so far required hospitalisation or other antiviral therapy as a result of COVID-19

·          CT-P59 was well tolerated and there was no clinically significant safety issues in the study population

NOVEMBER 5th 2020, INCHEON, KOREA – Celltrion Group today announced the 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 demonstrated a promising safety, tolerability, anti-viral 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 anti-viral 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.

“The COVID-19 pandemic remains a significant public health challenge for populations around the world. At Celltrion, we have focused on a holistic approach to the novel coronavirus by investigating candidates for the prevention, treatment as well as diagnosis of the virus,” said Dr Sang Joon Lee, Senior Executive Vice President of Celltrion. “In this study, the majority of enrolled patients were high risk old patients and no one treated with CT-P59 was developed to a severe condition whereas 33% of patients in placebo group was developed to be severe even in this small sample size study. We are encouraged by the promising results of the Phase I trial of CT-P59 for the treatment of COVID-19, as seen in mild patients.”

Celltrion has previously submitted the Investigational New Drug (IND) application for the clinical trial in globally, and plans to conduct further global Phase II and III trials including Korea. In addition, Celltrion has also initiated the 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.