Celltrion, a South Korean biopharmaceutical company, participated in the 2023 Digestive Disease Week (DDW) held in Chicago and online from May 6 to 9 local time
DDW is the largest international academic conference in the field of gastroenterology, hepatology, endoscopy, and digestive surgery, where experts from around the world gather to discuss the latest findings in research, medicine, and technology in the field.
At the conference, Celltrion presented the results of a global phase 3 clinical trial of its subcutaneous injection type autoimmune disease treatment, CT-P13 SC (Remsima SC), through oral presentations and posters. The trial was conducted on 343 patients with Crohn's disease and 438 patients with ulcerative colitis.
During the clinical trial, Celltrion administered the intravenous (IV) formulation of Remsima until the 6th week for the patients. After that, the patients who showed a clinical response to Remsima IV induction therapy at 10 weeks were randomly assigned to a Remsima SC-treated group and a placebo control group in a 2:1 ratio. The efficacy of Remsima SC compared to placebo in terms of maintenance treatment was confirmed.
The clinical trial results showed that Remsima SC was statistically superior to the placebo control group in terms of treatment efficacy after 54 weeks of maintenance treatment. In terms of safety, the Remsima SC administration group did not show any significant difference from the placebo control group, and no new safety-related concerns were found.
Celltrion had previously announced the clinical trial at the European Crohn's and Colitis Organization (ECCO) in February and introduced the efficacy and safety of Remsima SC through a poster at the Asian Organization for Crohn's & Colitis (AOCC) in April.
The study results are clinical data that were conducted by Celltrion for the purpose of obtaining new drug approval in the US for Remsima SC, which is Celltrion's next-generation strategic product that improves patient convenience with a subcutaneous injection formulation.
