Celltrion unveils phase 3 post-hoc data for Zymfentra at DDW 2025

Celltrion announced Tuesday that it released new post-hoc analyses from the global phase 3 trial of Zymfentra (ingredient: infliximab) during the 2025 Digestive Disease Week (DDW), held from May 3 to 6 in San Diego, the U.S.

DDW is the world’s largest academic conference dedicated to gastroenterology, bringing together over 10,000 medical experts annually to share the 3latest research, clinical updates, and therapeutic advancements. More than 4,000 abstracts and posters are presented each year, with inflammatory bowel disease (IBD) remaining a key area of focus.

At this year’s DDW, Celltrion disclosed post-hoc results from long-term follow-up studies of its global phase 3 trial involving Crohn’s disease (CD) and ulcerative colitis (UC) patients treated with Zymfentra. The findings covered one-year (54 weeks) and two-year (102 weeks) treatment periods and were presented across five scientific posters.

For the first time, Celltrion reported data identifying potential predictors of drug response among moderate-to-severe CD and UC patients undergoing maintenance therapy with Zymfentra.

The study found that patients who eventually lost response to the drug exhibited distinct baseline characteristics and clinical response patterns from the early stages of treatment compared to those who maintained response for two years.

Celltrion stressed that these findings suggest that early dose intensification may offer an effective strategy for optimizing disease control and drug durability.

Celltrion also presented four other post-hoc analyses that had previously been shared at the European Crohn’s and Colitis Organisation (ECCO) Congress.

These included data on endoscopic and histologic remission rates during maintenance therapy, the effectiveness of dose intensification for patients requiring it during maintenance, efficacy outcomes based on disease location in Crohn’s patients, and the long-term impact of immunogenicity among moderate-to-severe Crohn’s disease patients.

The data further confirmed the robustness of Zymfentra’s efficacy profile, which the company expects will increase both prescriber confidence and preference.

During DDW, Celltrion also hosted a dedicated booth and held seminars for IBD specialists to highlight the therapeutic benefits and competitive advantages of Zymfentra.

The company organized a symposium titled “TNF Inhibitors in Inflammatory Bowel Disease: How Can We Realize Opportunities to Optimize Clinical and Patient Outcomes?”, spotlighting the strengths of Zymfentra—the world’s only subcutaneous (SC) formulation of infliximab approved for use in TNF-α inhibition.

“Our extensive efficacy data presented at this global gastroenterology conference has been met with strong interest and positive feedback from international experts,” a Celltrion official said. “We believe the newly released findings will play a key role in expanding Zymfentra’s prescriptions and market share in the U.S.”