Celltrion moves another step forward in its bid to get a coronavirus disease 2019 (COVID-19) treatment on the market.
After receiving positive results from a phase 1 trial for its coronavirus disease 2019 (COVID-19) monoclonal antibody treatment (CT-P59), Incheon, Republic of Korea–based Celltrion Healthcare has received approval to initiate a phase 2/3 trial.
“Given that COVID-19 represents a significant global threat to life, there is an urgent need to identify treatments that can help stabilize our response to the pandemic. The initiation of the global phase II/III pivotal trial of CT-P59 is an important step forward,” said Sang Joon Lee, PhD, senior executive vice president at Celltrion, in a statement.
The news comes as Celltrion’s infliximab biosimilar (Remsima) is being tested in the phase 2 CATALYST trial to assess its efficacy in treating patients with inflammation linked to COVID-19 during hospitalization.
The phase 2/3 trial will be a global trial evaluating the safety and efficacy of CT-P59 in patients with mild-to-moderate symptoms related to COVID-19.
Celltrion, primarily a biosimilar developer and manufacturer, said it expects to have primary results for the phase 2 portion of the study by the end of 2020.
The company has filed an investigational new drug application for the trial in 6 countries, including the Republic of Korea, the United States, and Spain.
Celltrion said it plans to enroll more than 1000 patients in the multinational trial. Assuming the phase 2/3 trial yields positive results, the company expects to be able to apply for emergency use authorization.
“Celltrion has begun manufacturing the process validation batch of CT-P59 and plans to increase manufacturing capabilities to meet the current global and domestic demand for the anti-COVID-19 monoclonal antibody treatment candidate,” the company said in a statement.
In addition to the phase 2/3 trial, Celltrion has initiated an ongoing in-human global phase 1 trial for CT-P59 in patients with mild cases of COVID-19. The company said it also plans to investigate whether CT-P59 is effective as a preventive treatment for those who are in close contact with patients with COVID-19.