Celltrion, Inc. presented positive two-year results from the extended LIBERTY studies (LIBERTY-CD1 and LIBERTY-UC2) in patients with moderately to severely active Crohn?s disease (CD) and ulcerative colitis (UC). Celltrion also presented endoscopic outcomes from the post-hoc analysis of the LIBERTY-CD study. These data were presented as poster presentations at the 19th European Crohn?s and Colitis Organisation (ECCO) annual congress in Stockholm, Sweden.

Two-year results of CT-P13 SC LIBERTY studies: The LIBERTY-CD and LIBERTY-UC studies were continued up to 102 weeks as extension phase treatments, building on the initial LIBERTY trials. The two-year studies assessed the long-term efficacy and safety of CT-P13 SC in patients with Crohn's disease (CD) and ulcerative colitis (UC), respectively. In the CT-P13 SC LIBERTY-CD study, a total of 180 patients with moderately to severely active CD entered into the extension phase up to Week 102 and received CT-P13 SC 120mg regardless of the previous assigned arm of maintenance phase.

154 (85.6%) patients completed the extension phase, and efficacy results, including clinical remission, clinical response, endoscopic remission, endoscopic response, and corticosteroid-free remission, were generally maintained at Week 102 compared to Week 54. No new safety issues were reported during the extension phase. In the CT-P13 SC LIBERTY-UC study, a total of 237 patients with moderately to severely active UC entered into the extension phase and received CT-P13 SC regardless of the previous treatment group randomized at the start of maintenance phase.

The LIBERTY-UC study demonstrated sustained efficacy through Week 102, with 208 (87%) patients completing the extension phase. Clinical remission, clinical response, endoscopic-histologic mucosal improvement, and corticosteroid-free remission were generally well maintained at Week 102 compared to Week 54. No new safety concerns were observed during the extension phase.

Post-hoc analysis of CT-P13 SC LIBERTY-CD study: A separate post hoc analysis investigated the pattern of endoscopic mucosal healing across intestinal segments in patients with CD receiving CT-P13 SC maintenance treatment in the Phase 3 LIBERTY-CD study. The endoscopy study led to high and consistent endoscopic mucosal healing rates across all segments up to one year, including the terminal ileum, with CT-P13 SC maintenance therapy. The rates of endoscopic complete mucosal healing and partial mucosal healing were significantly higher in the CT-P13 SC arm compared to placebo.