South Korean-based Celltrion has initiated a phase 3 clinical trial of its COVID-19 targeting monoclonal antibody (mAb) as a preventative treatment.
The investigational mAb, CT-P59, will be investigated in approximately 1,000 patients who have been in contact with COVID-19 positive patients, to evaluate the efficacy of the treatment as a preventative measure.
The initiation of the trial follows approval of the investigational new drug (IND) application by the Korean Ministry of Food and Drug Safety (MFDS) on 8 October.
“We hope anti-COVID-19 monoclonal antibodies such as CT-P59 can provide high-risk individuals with effective protection against COVID-19 and help prevent further spread in the community,” said Sang Joon Lee, senior executive vice president of Celltrion.
“We look forward to continued data generation as this trial proceeds and we remain committed to combating the spread of the virus around the world,” he added.
Celltrion identified CT-P59 as a potential treatment for COVID-19 by screening antibody candidates and choosing ones which demonstrated the highest potency in neutralising SARS-CoV-2, the virus which causes COVID-19.
Pre-clinical data for the mAb demonstrated a 100-fold reduction in viral load of the novel coronavirus, in addition to a reduction in lung inflammation.
In September, Celltrion also announced interim results from a phase 1 clinical trial of CT-P59, which showed a promising safety, tolerability and pharmacokinetics profile for the drug.
In this early phase study, CT-P59 also demonstrated no significant drug-related adverse event, and there were also no adverse events from the maximum tolerated dose cohort.
If all goes to plan, Celltrion anticipates the development of CT-P59 will be complete by the first half of 2021, dependent on certain clinical and regulatory milestones.
“We launched commercial production of CT-P59 [in September] to ensure, if trials are successful, we can meet the urgent global demand for a safe and effective antiviral treatment against COVID-19,” Lee said in a statement.
“Should we receive positive results from our series of ongoing clinical trials, we intend to request emergency use authorisation for our drug,” he added.