[Edaily Reporter NA EUN-KYUNG ] Celltrion(068270)Celltrion is launching a U.S. Phase 4 clinical trial to establish the safety and efficacy of a 240 mg high-dose regimen of “Zimpendra” (active ingredient: infliximab), a treatment for autoimmune diseases.

Celltrion announced on the 15th that it has submitted an Investigational New Drug (IND) application for a Phase 4 clinical trial of the high-dose 240 mg Zimpentra to the U.S. Food and Drug Administration (FDA).

This clinical trial will be conducted at 55 sites across the U.S. and will enroll a total of 447 patients with Crohn’s disease (CD) and ulcerative colitis (UC). The trial will evaluate non-inferiority by comparing a group receiving high-dose intravenous (IV) infliximab with a group receiving Zimpentra 240 mg.

Through this clinical trial, Celltrion aims to establish clinical evidence for the 240 mg dose of Zimpentra and expand prescribing options in the U.S.—where prescriptions currently center on the 120 mg dose—so that physicians can select the appropriate dosage based on the patient’s condition and disease severity.

Zimpentra is the subcutaneous (SC) formulation of Celltrion’s infliximab biosimilar “Remsima” and received FDA approval in 2023 following the new drug approval process in the U.S. It is currently marketed in the U.S. as a treatment for Crohn’s disease and ulcerative colitis in adults.

Celltrion has previously utilized high-dose prescribing of Remsima SC in Europe. According to the company, Remsima SC recorded a market share of approximately 32% in the five major European countries (EU5) during the first quarter of this year. Celltrion initiated this clinical trial to apply the dose adjustment strategy currently used in Europe to the U.S. market as well.

In addition to establishing the evidence for high-dose administration, the company is also working to expand the drug’s indications. Celltrion is currently conducting a global clinical trial to add rheumatoid arthritis (RA) as an indication for Zimpentra, with the aim of broadening its prescription scope in the U.S., which is currently limited to inflammatory bowel disease (IBD). If this indication is added, Zimpentra’s potential patient population could also expand.

Sales in the U.S. are also on the rise. Zimpentra’s sales for the first half of this year reached 99.5 billion won, a 176.4% increase compared to the same period last year. According to Celltrion, Zimpentra currently has insurance reimbursement coverage of over 90% in the U.S. and is sold through the local subsidiary’s direct sales network.

Celltrion plans to pursue a prescribing strategy in the U.S. that utilizes both the existing 120 mg and the new 240 mg dosage once clinical data for the 240 mg dose is secured. The company intends to broaden Zimpentra’s prescribing scope in tandem with the expansion of its rheumatoid arthritis indication.

A Celltrion spokesperson stated, “This clinical trial is intended to broaden the dosage options for Zimpentra based on patient condition,” adding, “We will secure clinical data on high-dose administration and expand Zimpentra’s prescription base in the U.S. through the expansion of its indications.”