Hundred-time Meishi Shiguibao S1P subjectulation agent is expected to open up a "new battleground" for inflammatory bowel disease

Unsuperfected medical needs in patients with IBD Ulcerative colitis is a chronic inflammatory bowel disease (IBD) characterized by an abnormal, persistent immune response that produces persistent inflammation and ulcers in the mucous membranes of the large intestine or rectum.
symptoms include blood stools, severe diarrhea and frequent abdominal pain.
ulcerative colitis has a significant impact on the quality of life of patients, including physical function, social and emotional health, and ability to work.
many patients are not responding at all to the treatments currently available.
estimated that about 12.6 million people worldwide suffer from IBD, and in addition to UC, another common IBD is Crohn's disease.
currently, the treatment of IBD includes a variety of biological products that target TNF and erythrin (IL) signal path pathlines, as well as oral inhibitors that target JAK signal path paths.
, however, antibody biologics drugs often need to be administered under the skin or intravenously, and may gradually fail due to the patient's immune response to antibodies.
JAK inhibitors may inhibit multiple signaling path paths mediated by JAK family proteins, resulting in some patients not being able to withstand such treatments.
the "new battleground" of the next generation of S1P regulators mentions Zeposia (ozanimod), the first thing that comes to mind may be "it's a drug for multiple sclerosis (MS)."
, Zaposia was approved by the FDA in March to treat adult patients with multiple sclerosis.
Zeposia is an oral acetaminophen-1-phosphoric acid (S1P) subjectivity regulator that binds to S1P ligands 1 and 5 high affinity.
S1P subject regulator as a drug type has been repeatedly used in the treatment of MS.
novartis first received FDA approval to treat MS in 2010.
, the company's next-generation S1P regulator, Siponimod, was approved in 2019.
Janssen's S1P1 subject regulator, ponesimod, is also currently under FDA review and is expected to be approved for treatment of MS next year.
these drugs, in combination with S1P subjects on the surface of lymphocytes, prevent lymphocytes from leaving the lymph nodes, thereby reducing the immune system's attack on myelin, which protects nerves.
And in IBD, immune cell attacks on the intestinal mucous membranes are also a major cause of chronic inflammation, and by targeting S1P subjects, Zeposia may block the migration of lymphocytes to the intestinal mucous membranes, thereby reducing the inflammatory response.
Photo Source: In a multi-center, randomized double-blind, placebo-controlled Phase 3 clinical trial called True North, patients with moderate to severe ulcerative colitis who had not adequately responded to previous treatments were randomly treated with Zeposia or a placebo.
in the induction phase, a total of 645 patients were randomly assigned Zeposia (n-429) or a placebo (n-216), of which 94% and 89% completed the induction period, respectively.
during the maintenance period, 457 patients were randomly assigned to receive Zeposia (n=230) or placebo (n=227) maintenance therapy.
, 80 percent and 54.6 percent of patients who received Zeposia and a placebo completed the study, respectively.
results show that Zeposia not only reached the primary endpoint of the trial, but also reached a number of key secondary endpoints, including clinical response at week 10 of induction and week 52 of maintenance, endoscopy improvement, and mucous membrane healing.
, for example, more patients in the Zeposia treatment group had clinical responses (clinical response) at week 10 (47.8 percent than 25.9 percent, p.lt;0.0001) and 52 weeks (60.0 percent to 41.0 percent, p.lt;0.0001).
"Zeposia's results in the True North clinical trial are a significant achievement for patients with ulcerative colitis, many of whom have inadequate or no response to the treatments currently available," said Dr. Mary Beth Harler, director of immunology and fibrosis development at Pershing Mercer.
"In addition to treating ulcerative colitis, Shishi Shiguibao is conducting Phase 3 clinical trials at YELLOWSTONE to assess the efficacy and safety of Zeposia's treatment of moderate to severe active Crohn's disease.
Phase 3 clinical trial of innovative S1P regulators for the treatment of UC patients has been launched in China And other biopharmaceutical companies are developing specific S1P regulators for the treatment of a variety of immunometric and inflammatory diseases.
, for example, Arena Pharmaceuticals has developed etrasimod, a next-generation oral S1P regulator that combines with S1P subjectivity 1, 4, and 5 specificity and may have better efficacy/safety characteristics.
currently used in clinical trials of research therapies to treat UC, Crohn's disease, adiotic dermatitis and baldness. everest Medicines, which was officially listed on the Hong Kong Stock Exchange on September
, has been awarded a development interest in etrasimod in Greater China, where phase 3 clinical trials using the drug to treat UC patients are already in the patient registration stage.
Photo Source: Everest Medicines Website We wish the next generation of S1P-subject regulators a smooth development, not only for ulcerative colitis patients with oral treatment options with new mechanisms of action, but also for the benefit of more immuno-mediated and inflammatory disease patients.
: Bristol Myers Squibb Presents Positive Late-Breaking Data from Phase 3 True North Trial Evaluating Zeposia (Ozanimod) in Adult Patients with Moderate to Severe Ulcerative Colitis. Retrieved October 10, 2020, from .2. Retrieved October 11, 2020, from . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Retrieved October 11, 2020, from