Celltrion Presents Global Phase 3 Clinical Trial Results of 'Remsima SC' at the American Gastroenterological Association Meeting

Validation and Safety Confirmation
FDA Approval Expected Within the Year
"We Will Do Our Best to Complete the Remaining Approval Procedures"

Celltrion announced on the 10th that it participated in the '2023 Digestive Disease Week (DDW)' held in Chicago, USA, and online from the 6th to the 9th of this month (local time), where it presented two global Phase 3 clinical trial results of the subcutaneous injection formulation autoimmune disease treatment 'CT-P13 SC (Remsima SC)' through an oral presentation and a poster, respectively.

2023 American Digestive Disease Week (DDW) Celtrion Oral Presentation Session On-site.
[Photo by Celtrion]

The American Gastroenterological Association is the largest international academic conference in the field, gathering experts worldwide in gastroenterology, hepatology, endoscopy, and gastrointestinal surgery. This year, more than 3,100 abstracts related to the latest research, medicine, and technology in the field were disclosed.

The studies Celltrion presented through the oral and poster sessions at this conference are global Phase 3 clinical trial results conducted on 343 Crohn's disease patients and 438 ulcerative colitis patients. Celltrion administered Remsima intravenous (IV) formulation to patients participating in the clinical trial up to week 6. Among them, patients who showed a clinical response to Remsima IV induction therapy were randomly assigned at week 10 in a 2:1 ratio to the Remsima SC treatment group and the placebo control group, and subsequently, the statistical superiority in efficacy and safety of Remsima SC compared to placebo was confirmed during maintenance therapy.

According to the clinical results, after maintenance treatment with Remsima SC, statistically significantly higher therapeutic efficacy was observed at week 54 compared to the placebo control group, demonstrating the superiority of Remsima SC. In terms of safety, the Remsima SC treatment group showed no significant difference compared to the placebo control group, and no new safety concerns were identified.

Celltrion previously presented this clinical trial at the 'European Crohn's and Colitis Organisation (ECCO)' in February, a leading European inflammatory bowel disease conference. Subsequently, in April, the efficacy and safety of Remsima SC were introduced through a poster at the Asian Organization for Crohn's and Colitis (AOCC) conference.

The study results are clinical data conducted by Celltrion for the purpose of obtaining US new drug approval for Remsima SC. Remsima SC, which improves patient convenience with a subcutaneous injection formulation, was recognized by the US Food and Drug Administration (FDA) for product differentiation and was recommended to proceed with the new drug approval process. Accordingly, Celltrion completed the new drug application for Remsima SC to the FDA at the end of last year and expects to obtain approval by the end of this year.

A Celltrion official stated, "The study confirming the efficacy and safety of Remsima SC has been continuously accepted at globally renowned international academic conferences, confirming the competitiveness of Remsima SC," and added, "Based on the excellence of Remsima SC proven through clinical results, we will do our best to proceed with the remaining procedures to obtain US approval within this year."

Remsima SC. [Image provided by Celltrion]

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