S1P subject regulator Yunding Xinyao Pharmaceutical Co-technology New Drug Phase 3 Clinical Start Patient Recruitment.

On August 24th Everest Pharmaceuticals announced that it was recruiting patients in China for a randomized, placebo-controlled, double-blind, international multi-center Phase 3 clinical trial of etrasimod (APD334), a candidate innovative drug for the treatment of ulcerative colitis developed in collaboration with Arena Pharmaceuticals.
inflammatory bowel disease is an idynogenic intestinal inflammatory disease, including ulcerative colitis and Crohn's disease, the incidence is mostly in young adults, the pathogenesis is still not clear.
recent years, the incidence of inflammatory bowel disease in China has increased rapidly, with an estimated 1.5 million patients by 2025, which has become a common digestive disease affecting people's health.
new S1P subject regulator, etrasimod Etrasimod, is a new generation, oral, highly selective arginol 1-phosphate (S1P) regulator with the potential for superiority in its class.
based on existing research data and its selective binding to S1P subjects 1, 4 and 5, etrasimod may have better safety and ability than similar drugs available.
in a randomized, double-blind Phase 2 OASIS clinical trial conducted by Yunding Xinyao Pharmaceuticals partner Arena Pharmaceuticals for patients with moderate to severe ulcerative colitis (UC), etrasimod achieved a predetermined therapeutic endpoint and was well-to-resist.
New Yao Pharmaceuticals is currently conducting Phase 3 clinical trials of the product for UC, with a view to obtaining market approval for the treatment of moderate to severe UC patients in its business area.
Etrasimod also has the potential to treat other autoimmune adaptations, including Crohn's disease (CD) and allergic dermatitis.
is expected to become a new option for the treatment of ulcerative colitis At present, the treatment of ulcerative colitis is mainly to suppress inflammation of the intestines, however, the existing treatment methods such as aminoic acid, glucositogen, immunosuppressants or biological agents, etc., in terms of safety and effectiveness, are not satisfactory.
with the deepening of basic research on the immune system, the therapeutic targets related to the mechanism of inflammation are constantly discovered, and a variety of new targeted drugs have been introduced for treatment, providing new ideas for treatment.
, the phosphoric acid 1-phosphate (S1P) regulator is the current research and development hot spot, in August 22 held in the "2020 Xi'an IBD Summit Forum", has also been widely discussed and recognized by experts.
Chinese Professor Wu Kaichun, Vice Dean of Xijing Digestive Hospital affiliated with the Fourth Military Medical University of the People's Liberation Army, said: "The advantages of S1P subject regulators in treating ulcerative colitis are gradually being recognized, and their rapid effectiveness, continuous maintenance of remission, good safety, and easy oral use will provide new options for patients' treatment."
" Yunding Xinyao Pharmaceutical co-development of etrasimod (APD334), is the first in China to carry out ulcerative colitis Phase 3 clinical study of S1P subjectulation agent.
according to published Phase 2 Clinical Studies (OASIS) data, etrasimod has good effectiveness, safety and tolerance for moderate to severe active ulcerative colitis.
Etrasimod began to take effect quickly after taking the drug, and improvements in stool frequency and blood symptoms were observed at 1 week of medication, and significant improvements in histology were observed after 12 weeks of treatment, in addition to significant improvements in clinical symptoms, which was essential to reduce the recurrence of the disease.
follow-up long-term open label studies, etrasimod therapy continued to improve clinical remission rates and had a low risk of infection throughout the study.
References: The Chinese Medical Association's Digestive Credits Society Inflammatory Bowel Disease Group. Consensus Opinion on the Diagnosis and Treatment of Inflammatory Enteropathy (2018 Beijing) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Luo Ruili, Hollyo, Zhang Wei, Zhang Weinan.
meta-analysis of the causes of ulcerative colitis. Chinese Journal of Epidemiology, 2015, 36 (12): 1419-1423. [3] WangY, Ouyang Q, APDW 2004 Chinese IBD working group. Ulcerative colitis in China: retrospective analysis of 3 100 aused patients . J Gastroenterol Hepatol, 2007, 22 (9): 1450-1455. DOI: 10.1111/j.1440-1746.2007.04873.x. population⁃based cohorts: a system review . Clin Gastroenterol Hepatol. [5] Yashiro M. World J Gastroenterol. 2014 Nov 28;20 (44):16389-97. [6] Rutter M, Saunders B, Wilkinson K, et al. Gastroenterology. 2004 Feb;126 (2): 451-9. [7] Torres J, Billioud V, Sachar DB, et al. Inflamm Bowel Dis. 2012 Jul;18 (7):1356-63. [8] Berg DR, Colombel JF, Ungaro R. Inflamm Bowel Dis. 2019 Apr 1. pii: izz059. doi: 10.1093/ibd/izz059. [9] Peyrin-Biroulet et al. A new generation of oral, selective antiaminol-1-phosphate-subject regulator etrasimod (APD334) is safe and immunomodulated in healthy volunteers.
13th European Congress of Organizations for Crohn's Disease and Colitis;