Celltrion announced on the 15th that it has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for a phase 4 clinical trial in the United States to secure evidence for a 240mg high-dose regimen of its autoimmune disease treatment “Zympentra.”

This clinical trial will be conducted at 55 institutions in the United States with 447 patients with Crohn’s disease (CD) and ulcerative colitis (UC). The objective is to secure clinical data necessary for high-dose administration by comparing the non-inferiority of a high-dose infliximab intravenous (IV) regimen with a 240mg Zympentra regimen.

Through the trial, Celltrion plans to add a 240mg dose to the existing 120mg dose, thereby expanding prescribing options according to patient condition and disease severity.

In Europe, a high-dose prescribing strategy based on patient condition is already being applied to Remsima SC, the European product name for Zympentra. As of the first quarter of this year, Remsima SC recorded a market share of about 32% in the five major European countries (EU5). After securing high-dose clinical data in the United States, Celltrion plans to pursue a prescribing strategy that combines both 120mg and 240mg doses.

In parallel with dose expansion, the company is also working on adding indications. Celltrion is currently conducting a global clinical trial to add a rheumatoid arthritis (RA) indication for Zympentra, which is currently used for inflammatory bowel disease (IBD). If the RA indication is obtained, the patient population eligible for Zympentra prescriptions could be expanded beyond the current IBD-focused group.

Zympentra posted KRW 99.5 billion in sales in the first half of this year, an increase of 176.4% compared with the same period last year. According to Celltrion, insurance reimbursement coverage for Zympentra in the United States exceeds 90%.

Celltrion plans to expand the scope of prescriptions in the U.S. market by securing evidence for the 240mg high-dose regimen and adding the RA indication.

A Celltrion official said, “This is a clinical trial aimed at broadening treatment options based on patient condition,” adding, “We will expand Zympentra prescriptions in the U.S. market based on clinical data and our direct sales capabilities.”

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