In the treatment of ulcerative colitis, Bristol Myers Squibb S1P receptor regulator has obtained new indications
Bristol Myers Squibb (BMS) announced in June that the US FDA approved zeposia (ozanimod) 0.92 mg for the treatment of moderate and severe active ulcerative colitis (UC) in adults. The press release pointed out that this is the first oral S1P receptor modulator approved for the treatment of patients with moderate and severe active UC.
This approval is based on the results of a critical phase 3 clinical trial called true north. Compared with placebo, zeposia in the 10th week of induction treatment (18.4% vs 6.0%; P < 0.0001) and at the 52nd week of maintenance treatment (37.0% vs 18.5%; P < 0.0001) significantly increased the proportion of patients with clinical remission and reached the main end point of the trial. At the same time, zeposia achieved a number of key secondary endpoints, including clinical response, endoscopic improvement, endoscopic histological mucosal improvement and so on.
Ulcerative colitis is a chronic inflammatory bowel disease (IBD), which is characterized by long-term abnormal immune response, resulting in persistent inflammation and ulcer in the mucosa of colon or rectum. Symptoms include bloody stool, severe diarrhea and frequent abdominal pain. Ulcerative colitis has a significant impact on patients’ health-related quality of life, including physical function, social and emotional health, and work ability. Many patients have insufficient or no response to the currently available treatment.
Zeposia (ozanimod) is an oral S1P receptor regulator that binds to S1P receptors 1 and 5 with high affinity. Zeposia reduces the ability of lymphocytes to leave lymph nodes and reduces the number of circulating lymphocytes in peripheral blood. It has been approved by the FDA for the treatment of multiple sclerosis. At present, the mechanism of zeposia in the treatment of ulcerative colitis has not been fully clarified, but it may involve reducing the number of lymphocytes migrating to the inflamed intestinal mucosa.
“Despite a variety of approved therapies, UC patients still have unmet needs and need additional treatment options to help them better manage the disease.” Mr. Adam lenkowsky, head of the U.S. Department of cardiovascular, immunology and oncology of Bristol Myers Squibb, said: “we are very pleased that scientific research in immunology can bring a new treatment option for UC patients with different mechanism of action from existing therapies.”