#United States #Ulcerative Colitis #Crohn's Disease #Jersey City #ZYMFENTRA

Celltrion's ZYMFENTRA®: New Insights For IBD Treatment at ACG 2026

Celltrion USA, Inc., a prominent player in the biopharmaceutical sector, recently announced that it will be presenting two significant analyses of its product ZYMFENTRA® (infliximab-dyyb) at the American College of Gastroenterology (ACG) 2026 Annual Scientific Meeting. This event will take place from October 9 to 14, 2026, in Nashville, Tennessee. The focus of these presentations will be on evaluating the efficacy and clinical outcomes associated with subcutaneous and intravenous infliximab in the treatment of moderate-to-severe forms of Crohn's disease and ulcerative colitis.

The New Studies

The two analyses include a late-breaking pooled and propensity score-matched analysis comparing the effectiveness of subcutaneous versus intravenous infliximab specifically in patients with ileum-dominant Crohn's disease. The studies also feature a post hoc analysis exploring the effects of prior anti-drug antibody (ADA) status on clinical outcomes for patients receiving subcutaneous infliximab after an interruption of intravenous treatment.

Dr. Juby Jacob-Nara, Senior Vice President and Chief Medical Officer at Celltrion USA, stated, "People living with inflammatory bowel disease (IBD) can have diverse characteristics and treatment histories that shape their care pathways. Therefore, clinicians require evidence-based information that captures these variations. We are excited to share new findings regarding subcutaneous infliximab at ACG, underscoring Celltrion's commitment to advancing meaningful research for the IBD community."

Presentation Details

The analyses will be delivered by Dr. Marla Dubinsky, a Professor of Pediatrics and Director at the IBD Center at Mount Sinai in New York.

• - Post Hoc Analysis of LIBERTY-CD and -UC Studies Following an IV Infliximab Treatment Interruption

- Date: Tuesday, October 13, 2026
- Time: 2:45 - 2:55 PM CT
- Location: Karl F. Dean Grand Ballroom A, Level 4
- Abstract Title: "Impact of Prior Anti-drug Antibody Status on Clinical Outcomes Following Subcutaneous Infliximab Initiation After Intravenous Infliximab Interruption"
- Session: Plenary Session 3A IBD Presentation 40

In this analysis, data was drawn from participants in the placebo arms of two Phase 3 studies (LIBERTY-CD and LIBERTY-UC) who received a 240 mg dose of subcutaneous infliximab every two weeks after halting IV infliximab treatment. The results indicated that clinical outcomes remained relatively consistent, irrespective of prior ADA status.

Promising Findings in Ileum-Dominant Crohn's Disease

• - Late-Breaking Data in Ileum-Dominant Crohn's Disease

- Date: Wednesday, October 14, 2026
- Time: 9:30 - 9:40 AM CT
- Abstract Title: "Comparative Efficacy of Subcutaneous Versus Intravenous Infliximab in Ileum-Dominant Crohn's Disease"
- Session: Plenary Session 4B

This late-breaking abstract reported on individual patient data from four registrational studies involving 884 participants. Of these, 200 met eligibility criteria for the efficacy evaluation. The findings revealed that patients using subcutaneous infliximab exhibited significantly better clinical remission rates (71.4% versus 51.4%), improved endoscopic response rates (65.7% versus 27.1%), and heightened endoscopic remission rates (41.4% versus 17.1%) when compared to those on intravenous infliximab treatment.

Overall, Dr. Dubinsky highlighted that, despite the presence of prior anti-drug antibodies in some patients, initiating treatment with subcutaneous infliximab post-IV infusion interruption did not adversely affect clinical outcomes.

About ZYMFENTRA®

ZYMFENTRA® (infliximab-dyyb) is a prescription medication formulated for subcutaneous administration in adults for maintaining treatment of moderately to severely active ulcerative colitis and Crohn's disease. It operates by inhibiting tumor necrosis factor-alpha (TNF-alpha), a ligand implicated in inflammatory responses. Recently receiving FDA approval, ZYMFENTRA® is anticipated to revolutionize maintenance therapy for patients navigating these chronic conditions.

The ongoing research and presentations at ACG 2026 reflect Celltrion's dedication to enhancing patient care and treatment pathways in the realm of inflammatory bowel diseases. As the biopharmaceutical landscape evolves, initiatives like this continue to hold promise for expanding access and tailoring treatment for individual patient needs.