Celltrion Presents Follow-up Research on Zimpendra at European UEGW

Celltrion announced on the 16th that it gave an oral presentation of the post-analysis results of the global Phase 3 clinical trial of the autoimmune disease treatment Jimpendra (Remsima SC) at the ‘2024 United European Gastroenterology Week (UEGW)’ held over four days from the 12th to the 15th (local time) in Vienna, Austria. UEGW is considered the largest gastroenterology-related conference in Europe. It is a venue where various researchers and companies present the latest clinical research and drug development trends related to gastrointestinal diseases such as stomach cancer, inflammatory bowel disease (IBD), and immunology.

Celltrion's autoimmune disease treatment 'Zimpenetra'
[Photo by Celltrion]

At this conference, Celltrion disclosed the two-year (102-week) long-term follow-up study results of the global Phase 3 clinical trial of Jimpendra conducted on 192 Crohn’s disease patients and 237 ulcerative colitis patients. Following the announcement of the one-year (54-week) post-analysis results at UEGW last October, this year they additionally secured and presented clinical data on long-term efficacy, safety, and immunogenicity over two years.

Celltrion administered the intravenous formulation of Remsima to patients participating in the clinical trial up to week 6, and among those who showed a clinical response, patients were randomly assigned at week 10 to either the Jimpendra 120 mg treatment group or the placebo control group. Subsequently, dosing was conducted every two weeks for 54 weeks, demonstrating statistical superiority in efficacy and safety of Jimpendra compared to placebo. Patients who were judged to require dose escalation after week 22 had their Jimpendra dose increased from 120 mg to 240 mg and continued treatment up to week 102.

Patients who received the increased dose showed significant improvements in clinical remission, clinical response, and endoscopic response at week 102. Moreover, the majority of patients regained efficacy within eight weeks immediately after dose escalation. In terms of safety, there was no significant difference compared to the non-escalation group, and no new safety concerns were identified.

It was explained that this long-term follow-up study secured data not only on efficacy and safety but also on immunogenicity. During the 102 weeks of drug administration, the results of antibody formation against the drug and immune-related adverse event assessments in patients who had their dose escalated were not different from those who did not have dose escalation.

A Celltrion official stated, “These study results confirmed that Jimpendra can provide patients with a broad range of options in the treatment of inflammatory bowel disease,” adding, “We will continue research to enhance treatment efficacy and convenience for healthcare professionals and patients, while also increasing drug accessibility to rapidly expand market share.”