Celltrion Healthcare presented new data at the 18th European Crohn’s and Colitis Organisation (ECCO) annual congress in Copenhagen, Denmark. The data demonstrate the safety and efficacy of subcutaneous (SC) infliximab (CT-P13 SC) in patients with inflammatory bowel disease (IBD).
The LIBERTY Studies
The Phase III studies– LIBERTY-CD and LIBERTY-UC are randomised, placebo-controlled, double-blind trials that evaluated the superior effect of CT-P13 SC in efficacy and safety during maintenance therapy for patients with Crohn’s disease (CD) and ulcerative colitis (UC), respectively.
The CT-P13 SC LIBERTY-CD study enrolled 343 patients who were randomised 2:1 at week 10. At week 54, the patients demonstrated a clinical remission rate of 62.3% in the CT-P13 SC arm and 32.1% in the placebo arm.
The CT-P13 SC LIBERTY-UC study enrolled 438 patients who were randomised at week 10. The clinical remission rate at week 54 was 43.2% in CT- P13 SC and 20.8% in the placebo arm. The safety profile was comparable between CT-P13 SC and the placebo arms during the maintenance phase for both studies.
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“The positive global Phase III LIBERTY studies have allowed us to submit CT-P13 SC to the FDA as a stand-alone Biologics License Application under the 351 (a) pathway and the results have also reinforced our conviction in the value of CT-P13 SC,” said Kevin Byoung Seo Choi, Senior Vice President at Celltrion Healthcare.
“We believe that CT-P13 SC, if approved in the US, has the potential to become the next-generation innovative therapeutic for IBD given its favourable clinical results and convenient subcutaneous route of administration.”
CT-P13 SC PHASE I POST HOC ANALYSIS AND REAL-WORLD CASE STUDIES
A separate post hoc analysis of the randomised Phase I CT-P13 SC study data showed Ctrough level predicted anti-drug antibody (ADA) and neutralising antibody (NAb) positivity in CD and UC patients, with a Ctrough threshold of 4.695μg/mL significantly associated with lower rates of ADA and NAb positivity.
Real-world studies suggest that the reintroduction of CT-P13 SC may be a treatment option for CD patients with previous anti-TNF treatment failure by aiming to reach a higher pharmacokinetics level and lower anti-drug antibody levels.
Interim results of a pilot study indicate that CT-P13 SC may also be a treatment option for patients with refractory CD.
“Whilst there have been numerous recent advancements in IBD treatment options, there remains a pressing demand to address unmet medical need, especially for refractory IBD patients,” said Professor Milan Lukas, ISCARE and Charles University, Czech Republic.
“These exploratory results suggest that SC infliximab could provide healthcare providers with a powerful treatment tool for CD patients who have previously been considered difficult to treat.”
Celltrion was involved with Covid-19 therapy development during the pandemic, with its regdanvimab showing neutralising potency against the virus.