Type: Monoclonal antibody treatment targeting COVID-19
Status: Celltrion Group said October 13 it launched a Phase III trial investigating CT-P59 as a preventative measure against COVID-19. The trial was initiated after the Korean Ministry of Food and Drug Safety (MFDS) approved an Investigational New Drug (IND) application on October 8.
The post-exposure prophylaxis clinical trial is designed to evaluate the preventive effect and safety of CT-P59 and whether CT-P59 can elicit a neutralizing antibody response to prevent the virus from infecting human cells. Celltrion said it anticipated the enrolment of approximately 1,000 patients to evaluate population-based prophylaxis in contacts of SARS-CoV-2 infected patients.
The MDFS has also approved Celltrion’s IND application to initiate a Phase II/III pivotal trial of this potential treatment in mild-to-moderate patients.
In July, Celltrion launched a Phase I trial (NCT04525079) in South Korean designed to evaluate a potential antiviral antibody treatment for COVID-19 in 32 healthy volunteers, in collaboration with Chungnam National University Hospital. The trial showed positive results for safety, tolerability, and pharmacokinetics, Celltrion announced in September, adding that the results demonstrated no significant drug-related adverse events, and no adverse events from the maximum tolerated dose cohort
At that time, Celltrion had initiated an in-human, global, Phase I clinical trial of CT-P59 in mild COVID-19 patients with plans to conduct further global Phase II and III trials in 500 patients from 12 countries including Korea. Celltrion anticipated the enrolment of a total of 3,000 patients including those involved in the prevention clinical trial, investigating the use of CT-P59 as a preventative treatment for COVID-19 in those in close contact with COVID-19 patients.
Celltrion anticipated that it would complete the development of CT-P59 by the first half of 2021.
The company said its antiviral antibody treatment had earlier shown itself to effectively neutralize the mutated G-variant strain (D614G variant) associated with the increased viral transmission and wide spread of COVID-19. “We remain committed to carrying out local and global clinical studies with the goal of commencing mass production of the therapeutic antibody treatment in the latter half of this year,” stated Sang Joon Lee, PhD, Senior Executive Vice President of Celltrion.
In May, Celltrion said it will conduct additional preclinical efficacy and toxicity tests for its COVID-19 antiviral treatment, after it showed positive preclinical results—namely a 100-fold reduction in the viral load of SARS-CoV-2, and the improvement in animal models of lung lesions to a normal activity level.
The preclinical study, conducted in collaboration with Chungbuk National University College of Medicine, was designed to assess the efficacy of two dosage amounts (low and high) for the antiviral antibody treatment. Compared to the placebo-controlled group, the research team saw improved clinical symptom scores such as runny nose, cough and body aches, after the first day of treatment. Significant clinical remission was observed from the fifth day.
Samples from the high-dose group saw the viral load reduce by 100-fold, while lung biopsy showed that both dosage groups saw inflammation returning to normal lung tissue histopathology within six days as well as a shortened recovery time, whereas the placebo-controlled group experienced sustained levels of lung inflammation and complications. To analyze specimens from the upper respiratory tract (nasal discharge and nasal turbinate) and the lungs, researchers used reverse transcriptase polymerase chain reaction (RT-PCR) measurement and cell culture-based viral diagnosis.
In April, Celltrion said it had begun the second phase of development for an antiviral treatment, in which it will partner with the Korea Centers for Disease Control and Prevention (KCDC) to screen antibodies to find the ones most effective in neutralizing SARS-CoV-2. The company in March secured 300 different types of antibodies that bind to the antigen last month during the first phase, creating a library of antibodies using the blood of recovered patients in South Korea.
In addition, Celltrion aims to launch a rapid self-testing diagnostic kit that could provide results within 15-20 minutes. The South Korean biologics developer has been selected as a preferred developer for a monoclonal antibody project to treat and prevent COVID-19 by KCDC. Celltrion also plans to develop a ‘super antibody’ candidate that can attach and neutralize multiple coronavirus related strains, including those causing COVID-19 and SARS.
COVID-19: 300 Candidates and Counting
To navigate through the >300 potential therapeutic and vaccine options for COVID-19, GEN has grouped the candidates into four broad categories based on their developmental and (where applicable) clinical progress:
● FRONT RUNNER – the most promising therapeutics/vaccines based on clinical progress, favorable data or both.
● DEFINITELY MAYBE – earlier phases with promising partners, or more advanced candidates in development that have generated uneven data
● KEEPING AN EYE ON… – interesting technology, attracting notable partners, or both, but preliminary data.
● TOO SOON TO TELL – longshots pending additional experimental and/or clinical data.
GEN has also tagged the most common treatment types: