Celltrion Reveals First Post-Hoc Analysis Results of Remsima SC Phase 3 Clinical Trial

Presented at the European Society of Gastrointestinal Diseases on the 17th
Confirmed efficacy recovery effect with increased dosage

Celltrion on the 17th (local time) unveiled the post-analysis results of the global Phase 3 clinical trials of the autoimmune disease treatment RemsimaSC for the first time at the '2023 United European Gastroenterology Week (UEGW)' held in Copenhagen, Denmark.

The research results announced by Celltrion this time are from two newly conducted global Phase 3 clinical trials for the approval of RemsimaSC (U.S. brand name: Zimpenetra) in the United States, focusing on 'dose escalation' and 'RemsimaSC monotherapy without concomitant immunosuppressants.'

Celltrion explained, "Through post-analysis, we confirmed the efficacy recovery effect in patients who lost response," adding, "We also obtained similar effects for the RemsimaSC monotherapy regimen compared to the existing concomitant immunosuppressant therapy." In particular, this study revalidated that RemsimaSC is effective for patients with Inflammatory Bowel Disease (IBD) while additionally securing clinical data on the dosing convenience and expanded indications of RemsimaSC.

Celltrion conducted clinical trials on 343 Crohn's disease patients and 438 ulcerative colitis patients who showed clinical response after receiving Remsima intravenous (IV) formulation induction therapy up to week 6. From week 10, patients were randomly assigned in a 2:1 ratio to the RemsimaSC 120mg treatment group and placebo control group, respectively, and dosed every two weeks for 54 weeks to ensure efficacy and safety.

Post-analysis results on dose escalation showed that increasing the dose to 240mg in patients who lost response in the RemsimaSC 120mg group was effective in restoring efficacy. Safety also showed no significant difference compared to the non-escalation group, and no new safety concerns were identified.

Along with this, Celltrion presented a poster on the efficacy of RemsimaSC monotherapy through a post-analysis comparing the RemsimaSC monotherapy group and the immunosuppressant combination therapy group. According to Celltrion, while previous studies on infliximab IV formulation indicated that combination therapy with immunosuppressants was more effective, the post-analysis comparing RemsimaSC monotherapy and combination therapy groups showed similar levels of efficacy. Safety was also generally comparable between the two groups. Notably, the infection rate was reported to be lower in the RemsimaSC monotherapy group. This suggests that RemsimaSC monotherapy could be a viable option for patients who previously chose combination therapy for efficacy despite the side effects of immunosuppressants.

Celltrion stated, "The safety and efficacy results of RemsimaSC dose escalation and RemsimaSC monotherapy without immunosuppressants are expected to have a positive impact on the expanded prescription of RemsimaSC in global medical settings, including the United States."

RemsimaSC continues its growth momentum in Europe, where it was first launched. According to Celltrion Healthcare and IQVIA, as of the first quarter of this year, Remsima and RemsimaSC combined held a 68.5% market share in the five major European countries (EU5). Celltrion has completed two new global Phase 3 clinical trials for the new drug launch of RemsimaSC in the U.S. and has applied for FDA approval under the U.S. brand name 'Zimpenetra,' expecting approval this month. If approved as a new drug in the U.S., it will be able to maintain long-term market patent rights, securing an absolutely advantageous position in targeting the infliximab market in the U.S.

A Celltrion official said, “Following multiple clinical results confirming the efficacy and safety of RemsimaSC, the post-analysis results of the global Phase 3 clinical trials allow us to anticipate a broader prescription environment for RemsimaSC. Based on the proven excellence of RemsimaSC through clinical results, we will proceed smoothly with the U.S. approval process and do our best to supply high-quality biopharmaceuticals not only in the European market but also in the U.S., the world’s largest pharmaceutical market.”

This content was produced with the assistance of AI translation services.