Celltrion "Jimpentra Dose-Adjusted Patients Show Symptom Improvement at 102 Weeks Evaluation"

Celltrion Zympenta. Photo by Celltrion

Celltrion announced on the 7th that it revealed the long-term post-analysis results of the global Phase 3 study of the autoimmune disease treatment 'CT-P13 SC' (infliximab subcutaneous formulation, U.S. product name: Zimpenetra) at the '2025 Crohn's Disease and Colitis Congress (CCC)'.

CCC is a leading inflammatory bowel disease (IBD) conference in the United States, where gastrointestinal disease experts from around the world gather to share the latest research, clinical information, and trends in therapeutic development related to the disease. This year, it is held over three days starting on the 6th (local time) in San Francisco, USA.

The study disclosed by Celltrion pertains to dose escalation results during the 102-week (approximately 2 years) long-term follow-up of the global Phase 3 clinical trial of Zimpenetra. The abstract of this study was presented as a poster.

Celltrion conducted a post-analysis up to 102 weeks in the Phase 3 clinical trial involving 192 Crohn's disease (CD) patients and 237 ulcerative colitis (UC) patients, comparing the efficacy, immunogenicity, and safety between patients who received an increased dose of CT-P13 SC from the original 120 mg to 240 mg and those who did not receive dose escalation.

The results showed that patients who underwent dose escalation after 22 weeks demonstrated significant improvements at week 102 in clinical remission, clinical response, and endoscopic response, which assess the degree of symptom improvement.

Furthermore, the majority of dose-escalated patients exhibited better efficacy within 8 weeks after the dose increase. In terms of safety, there was no significant difference compared to the non-escalation group, and no new safety concerns were identified.

Through these study results, Celltrion reaffirmed that it can provide various treatment options for inflammatory bowel disease, and it expects that U.S. physicians' preference for prescribing Zimpenetra will increase.

A Celltrion representative stated, "Research results demonstrating the therapeutic efficacy and safety of Zimpenetra continue to be presented at numerous prestigious international academic conferences, garnering significant interest and positive responses from medical professionals. We will continue research to enhance the product’s competitiveness to increase prescription preference in future medical environments, while also striving to improve treatment accessibility to rapidly expand market share."