Celltrion unveils global clinical trial phase 1 result of CT-P10
ACR annual conference A randomized, double-blind, parallel-group, phase 1 trial comparing the pharmacokinetics, safety and efficacy of CT-P10 and its originator, rituximab in patients with rheumatoid arthritis is unveiled at the ACR annual conference in San Diego
SAN DIEGO, US, Oct 28, 2013.
Celltrion Inc. revealed the results of the phase 1 of global clinical trial of CT-P10 conducted with 150 patients who did not previously show response to TNF-alpha inhibitors for their rheumatoid arthritis at the ACR(American College of Rheumatology) 2013. CT-P10, third biosimilar candidate developed by Celltiron, is a kin version of rituximab, biologic agent for rheumatoid arthritis and certain other kinds of hematologic diseases. The study revealed that CT-P10 was equivalent to the original drug in all aspects observed in pharmacokinetics, efficacy and safety.
The global clinical trial Phase I was conducted at thirty-eight hospitals in eight countries with 150 patients who did not respond to TNF-α inhibitors over 24 weeks. To demonstrate pharmacokinetic equivalence, parameters such as AUC(Area Under the Curve), Cmax(Peak serum Concentration) were evaluated, and for evaluating clinical comparability, ACR20/50/70, ESR, CPR were evaluated. After 24 week from the first administration, at the evaluation time point, in all clinical domains, no significant statistical differences were observed between CT-P10 and its originator. Immunogenicity were observed in both arms and developing immunogenicity affected to overall responses and PKs. The proportion of patients who developed Antidrug Antibodies (ADA) during the study was similar in both treatment groups for up to week 24.
The safety profile for CT-P10 and rituximab were comparable in all categories (TEAEs, SAEs, infection and infusion-related reactions) at 24 week
An official from celltrion said “Development of our third product is going very smoothly with successful clinical trial phase1 result of CT-P10. Celltrion is preparing for global clinical trial phase3. The official further elaborated “Announcement of successful clinical trial phase 1 result of CT-P10 is meaningful for Celltrion as this announcement consolidates company’s position as a leader in biosimilar development.”
The original product of CT-P10 is used to treat not only rheumatoid arthritis but also for non-Hodgkin’s lymphoma. The original product of CT-P10 is a blockbuster mAb which recorded sales of USD 7.1 billion world-wide last year.
ACR is one of the largest global rheumatology conferences along with EULAR, with more than 15,000 medical doctors, health professionals, and clinical trial experts participate in ACR annually