Celltrion antibody anti-SARS-CoV-2 has improved outcomes in patients with moderate to severe COVID-19 in a phase 2/3 clinical trial. Korean biopharma reported lower progression rates to solid COVID-19, time shortened to clinical recovery and reduced viral depletion in patients on the drug.
Similar to anti-SARS-CoV-2 antibodies developed by Eli Lilly and Regeneron, CT-P59 at Celltrion is designed to improve outcomes in COVID-19 patients by neutralizing the coronavirus. Building on preclinical evidence of efficacy, Celltrion CT-P59 moved to a phase 2/3 clinical trial in October. Highline data from the 327 subjects enrolled in the first part of the study are now available.
Participants randomized participants to receive one of two doses of CT-P59, 40 mg / kg or 80 mg / kg, or placebo. The baseline data shared by Celltrion cover only the lower of the two doses of CT-P59.
Celltrion reported that the 40-mg / kg dose reduced progression to acute COVID-19 by 54% against placebo at Day 28. In a subgroup of moderate COVID-19 patients aged 50 years and older, the reduction was at 68%. More than half of the moderate COVID-19 patients in the study had virus-associated pneumonia.
Patients received the low dose of CT-P59 over 5.4 days, compared with 8.8 days in the placebo arm. The difference in recovery times was greater in some subgroups of patients. Subjects suffering from pneumonia recovered at 5.7 days on the low dose of CT-P59, as opposed to 10.8 days for their placebo peers. In patients age 50 years and older, CT-P59 and placebo recovery times were 6.6 days and 13 days, respectively.
Viral loading dropped significantly against placebo at Day 7. Lilly missed the viral load limit when she tested her antibody anti-SARS-CoV-2 in moderate-to-severe COVID-19 cases. However, Lilly ‘s trial assessed viral loading at Day 11, when many patients in the placebo group may have fought off the virus without the help of medication.
Lilly and Regeneron have since gone on to obtain emergency use clearance for their antibodies. Celltrion sees market opportunity for another anti-SARS-CoV-2 antibody, however, and is preparing to produce enough doses to treat approximately 2 million patients this year.
If the effects seen in the clinical trial are reproducible in the real world, CT-P59 may help reduce stress on health care systems by preventing patients from needing intensive care. and getting them well enough to leave the hospital sooner. Celltrion filed for a conditional marketing license in Korea at the end of last year and promised to seek permission in the U.S. and Europe in the coming months.