Celltrion: Zymfentra Demonstrates Long-Term Safety and Efficacy in Phase 3 Extension Study

Securing Evidence for Long-term Prescription of Zymfentra
Expectations for Expanded Prescriptions in the US Market

Celltrion announced on April 24 that a paper detailing the long-term results of a global Phase 3 clinical trial for its autoimmune disease treatment 'CT-P13 SC (infliximab subcutaneous formulation, marketed as Zymfentra in the United States)' has been published in the international journal 'Journal of Crohn's and Colitis'.

This journal is the official publication of the European Crohn's and Colitis Organisation (ECCO). It is recognized as a highly influential journal in the fields of gastroenterology and inflammatory bowel disease (IBD). Celltrion presented the results of a long-term maintenance therapy study conducted over 102 weeks (approximately 2 years) as part of the global Phase 3 clinical trial for CT-P13 SC.

The 102-week extension study was designed as an open-label trial in which all patients received CT-P13 SC. A total of 278 patients with Crohn's disease and 348 patients with ulcerative colitis participated. This study evaluated the overall long-term treatment effects of CT-P13 SC, including efficacy, safety, pharmacokinetics, and pharmacodynamics, based on previous 54-week clinical data.

In the clinical trial, patients initially received CT-P13 in intravenous (IV) form for 6 weeks. Patients who demonstrated a therapeutic response were then randomly assigned at week 10 to receive either CT-P13 SC 120 mg or placebo until week 54. Notably, patients who required dose escalation after week 22 were allowed to increase the dose to 240 mg. All patients who entered the extension study subsequently continued treatment with CT-P13 SC monotherapy up to week 102.

The results showed that CT-P13 SC maintained stable efficacy, safety, and tolerability even with long-term administration, and also demonstrated positive outcomes in terms of pharmacokinetics and pharmacodynamics. The treatment showed significant effects on key indicators such as clinical remission and endoscopic response, and no new safety concerns were identified in the dose escalation group.

A Celltrion representative stated, "Through this clinical trial, we have additionally secured evidence for the sustained therapeutic effect and long-term prescription of CT-P13 SC, which is expected to help expand prescriptions in the United States. As Zymfentra is the only subcutaneous formulation among infliximab-based treatments preferred for IBD that offers improved dosing convenience, we will do our best to enhance accessibility for both patients and healthcare professionals."

Meanwhile, Celltrion is strengthening its competitiveness in the global market and accelerating the expansion of its market share based on its robust portfolio of autoimmune disease treatments. In particular, in major countries such as the United States and Europe, the company plans to expand prescribing experience through communication with healthcare professionals and actively implement customized strategies tailored to each country's treatment environment.