Celltrion presents Phase I data for CT-P13
Celltrion Inc. (KOSDAQ:068270) presented Phase I data comparing its CT-P13 with Remicade infliximab from Johnson & Johnson (NYSE:JNJ) and partner Merck & Co. Inc. (NYSE:MRK) at the European League Against Rheumatism meeting on Thursday. In 250 patients with active ankylosing spondylitis in the Phase I PLANETAS trial, CT-P13 and Remicade had similar pharmacokinetics and no significant differences on a number of clinical endpoints at weeks 14, 30 and 54. The 90% CI for the ratio of peak plasma concentrations between CT-P13 and Remicade were within the 80-125% margin for bioequivalence up to week 54. Additionally, the proportion of patients who developed antibodies against infliximab was similar between treatment groups through week 54. Treatment-related adverse events, infections and infestations, infusion-related reactions and serious adverse events were also similar between the groups. Celltrion published 30-week data from the trial in the Annals of the Rheumatic Diseases last month. ...