In the effort to find treatments for coronavirus disease 2019 (COVID-19) and related conditions, Celltrion Healthcare’s monoclonal antibody has shown promise in a phase 1 trial.
As several biosimilar developers are working to find treatments for coronavirus disease 2019 (COVID-19), Incheon, Republic of Korea–based Celltrion Healthcare said a phase 1 trial for its monoclonal antibody treatment (CT-P59) showed positive results for safety, tolerability, and pharmacokinetics.
This comes as the company’s infliximab biosimilar (Remsima) is currently under evaluation in the CATALYST trial for potential in treating patients with COVID-19-related inflammation during hospitalization.
“Whilst the CATALYST trial aims to show that our drug could delay or prevent the rapid deterioration into intensive care for hospitalized patients, our antiviral antibody treatment aims to prevent the infection and proliferation of COVID-19. However, both involvements are for the same objective: to bring our full resources and expertise to overcome this global health crisis and dedicate our efforts to support health care systems across the world,” said Byoungseo Choi, head of marketing for Celltrion Healthcare in a recent interview with The Center for Biosimilars®.
Trial Details and Timeline
The phase 1 randomized, double blind, placebo-controlled trial evaluated the safety of CT-P59 in healthy subjects. Study results demonstrated that CT-P59 did not cause any significant drug-related adverse events. Additionally, there were no adverse events in the maximum-tolerated-dose cohort.
“Along with these promising safety results, we have launched commercial production of CT-P59 this month to ensure, if trials are successful, we can meet the urgent global demand for a safe and effective antiviral treatment against COVID-19,” said Sang Joon Lee, PhD, senior executive vice president of Celltrion, in a statement.
Lee said that Celltrion plans to request emergency use authorization for CT-P59 if positive results continue to be seen during its other ongoing clinical trials.
Celltrion has so far initiated an in-human, global phase 1 clinical trial of CT-P59 in patients with mild cases of COVID-19 and said that it plans to conduct global phase 2 and phase 3 trials in 500 patients from 12 countries, including the Republic of Korea.
Celltrion said it anticipates enrolling a total of 3000 patients in clinical and prevention trials, which will investigate whether CT-P59 can be used as a preventive treatment for COVID-19 for those in close contact with patients who have the disease.
Celltrion said it aims to complete the development of CT-P59 by the first half of 2021. The company announced it was joining the race to develop a COVID-19 antibody treatment in April and planned to complete the phase 1 trial for CT-P59 by the end of the third quarter of 2020.
Other Notable Celltrion News
The news comes several weeks after Celltrion announced it would begin a phase 1 trial in September for its osteoporosis biosimilar (CT-P41) referencing Prolia.
Alos, in August, Celltrion said that it is collaborating with Intract Pharma to develop the world’s first oral infliximab for the treatment of inflammatory bowel disease.
This year, the World Health Organization prequalified 2 of Celltrion’s biosimilars, including its trastuzumab (Herzuma) molecule, which launched in the United States in March for the treatment of HER-2 positive breast cancer, and its rituximab molecule (Truxima) for treating non-Hodgkin lymphoma and chronic lymphocytic leukemia.