Celltrion has announced that results from the ongoing Phase I trial showed the monoclonal antibody treatment candidate, CT-P59, demonstrated a promising safety, tolerability, antiviral effect and efficacy profile in patients with mild symptoms of Covid-19.
The potential Covid-19 treatment candidate was identified on screening multiple candidates and choosing those with the highest potency in neutralising the SARS-CoV-2 virus, including the mutated G-variant strain (D614G variant).
The global, randomised, double-blind, placebo-controlled and parallel-group trial is analysing the safety, tolerability and antiviral effect of CT-P59.
It enrolled 18 patients with mild Covid-19 symptoms. They were randomised into three cohorts, where 15 patients received CT-P59 at 20mg/kg, 40mg/kg or 80mg/kg respectively, and the others received placebo.
According to the results, patients who received CT-P59 experienced a roughly 44% reduced mean clinical recovery time as compared to the average placebo recovery time.
Data showed that no patients treated with CT-P59 required hospitalisation or antiviral therapy.
Moreover, no treatment-emergent serious adverse events or clinically significant treatment-emergent adverse events were observed.
Incheon Medical Centre Department of Internal Medicine Division of Infectious Disease professor Jin Yong Kim said: “This is positive and encouraging efficacy and safety data showing accelerated recovery time in patients with mild symptoms of Covid-19.
“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 submitted the Investigational New Drug (IND) application for the global trial and intends to carry out further global Phase II and III trials in Korea.
The company is also conducting a post-exposure prophylaxis trial to analyse CT-P59 as a protective treatment by assessing the efficacy of the treatment in people who have confirmed exposure to SARS-CoV-2.
In August, Celltrion got approval from the Korean Ministry of Food and Drug Safety (MFDS) to conduct the Phase I trial of CT-P59 against Covid-19.