Celltrion said that is has presented the phase 1, part 2 trial results for Remsima SC in treating inflammatory bowel disease (IBD), at the United European Gastroenterology Week in Barcelona, Spain.
Remsima SC is the world’s first infliximab subcutaneous formulation drug developed by Celltrion and received approval recommendations from the European Medicines Agency’s Committee for Medicinal Products for Human Use Substance User Advisory Committee (CHMP) in September.
The company expects to receive sales approval for the drug by the end of this year.
The clinical study, participated in by 136 patients with Crohn’s disease or ulcerative colitis, either gave a subcutaneous (SC) injection or intravenous (IV) injection or Remsima. After confirming the non-inferiority of SC compared to IV, the company compared the efficacy and safety for 30 weeks.
Celltrion confirmed similar results in both the Remsima SC-administered group and the Remsima IV-administered group.
“These clinical findings confirmed similarities in efficacy and safety between the Remsima IV and SC formulations in IBD indications,” said Professor Stefan Schreiber, director of the clinic for internal medicine at Kiel Campus of the University Hospital Schleswig-Holstein in Germany.
Remsima SC is an infliximab ingredient highly preferred by medical workers in treating IBD, which is a large part of the autoimmune treatment market, and it is an attractive treatment for medical staff and patients around the world, Schreiber added.
The company also presented a long-term safety analysis of more than 2,800 patients with IBD in a post-marketing study (PMS), out of 4,400 patients who received Remsima IV.
The study analyzed the real-world data (RWD) after the drug received sales approval and demonstrated that the drug had no safety issues even in long term use.
“Celltrion’s announcement was selected as the top 12 posters with excellent academic value in the related field session among the 2,080 posters submitted to this year’s conference,” the company said.
Lee Sang-joon, Celltrion’s senior vice president of clinical development division, also said, “Due to clinical results presented at the European League Against Rheumatism (EULAR) and the UEGW, Remsima SC has attracted much attention from the practitioners of rheumatoid arthritis and inflammatory bowel disease around the world.”
As the safety and effectiveness of Remsima SC, which was developed according to medical needs, have been proven through clinical results, Celltrion will continue to promote the drug to become a global blockbuster, Lee added.