Celltrion Unveils Zympentra Phase 3 Post-Hoc Analysis Results at U.S. Digestive Disease Week

Celltrion's autoimmune disease treatment drug 'Zympentra'. Photo by Celltrion

Celltrion announced on May 7 that it unveiled the results of a global Phase 3 post-hoc analysis of Zympentra (ingredient: infliximab) at the 2025 Digestive Disease Week (DDW), which was held in San Diego, United States, from May 3 to 6 (local time).

DDW is the world’s largest academic conference for sharing the latest research, clinical information, and trends in drug development related to gastroenterology. Each year, more than 10,000 medical experts in gastrointestinal diseases from around the world attend, and over 4,000 abstracts and posters are presented. The conference serves as a venue for sharing and discussing the latest medical trends in the field of inflammatory bowel disease (IBD).

The clinical results disclosed by Celltrion at this conference pertain to the post-hoc analysis of long-term follow-up data from the global Phase 3 trial of Zympentra, conducted with patients with Crohn's disease (CD) and ulcerative colitis (UC). The analysis covered one-year (54-week) and two-year (102-week) periods, and a total of five posters were presented.

For the first time, Celltrion revealed results identifying 'predictive factors' for patient drug response during maintenance therapy with Zympentra in patients with moderate to severe CD and UC.

The study found that patients who experienced loss of drug response during Zympentra maintenance therapy exhibited distinct baseline characteristics and clinical response patterns from the early stages of treatment, compared to those whose response was maintained for up to two years. This suggests that early dose escalation may be an effective strategy for optimizing treatment control and drug maintenance.

In addition, as a post-hoc analysis of the Phase 3 results previously presented at the European Crohn’s and Colitis Organisation (ECCO), Celltrion also presented four posters on: endoscopic and histologic remission rates during maintenance therapy; the effects of dose escalation in patients requiring it during maintenance therapy; efficacy according to Crohn's disease location; and the long-term impact of immunogenicity in patients with moderate to severe Crohn's disease. These additional efficacy data for Zympentra are expected to further increase healthcare professionals’ trust in and preference for prescribing the product.

During the academic conference, Celltrion set up an independent booth and held seminars for IBD healthcare professionals to highlight the therapeutic efficacy and competitive advantages of Zympentra. On May 4, a symposium was held on the topic "TNF Inhibitors in Inflammatory Bowel Disease: How Can We Realize Opportunities to Optimize Clinical and Patient Outcomes?" The event highlighted the excellence of Zympentra, the world’s only subcutaneous (SC) infliximab formulation among TNF-alpha inhibitors, attracting significant interest and positive response from attending medical professionals.

A company representative stated, "Global experts have responded positively and shown strong interest in the diverse efficacy data for Zympentra unveiled at this international gastroenterology conference. We expect that the research results presented at this meeting will play an important role in increasing Zympentra prescriptions and expanding its market share in the United States."