This morning, BMS said Zeposia achieved positive topline results in the Phase III True North clinical study in patients with moderate to severe ulcerative colitis.
Zeposia recieved top line results in the ulcerative colitits study
One day after Bristol Myers Squibb announced the commercial launch of multiple sclerosis drug Zeposia (ozanimod), the company said the medication demonstrated statistically significant efficacy as a potential induction and maintenance therapy for ulcerative colitis.
This morning, BMS said Zeposia achieved positive topline results in the Phase III True North clinical study in patients with moderate to severe ulcerative colitis. Zeposia demonstrated highly statistically significant results for induction of clinical remission at Week 10 and in maintenance at Week 52, the company said. The True North study also met key secondary endpoints of clinical response and endoscopic improvement in induction at Week 10 and in maintenance at Week 52. The safety profile of Zeposia remained consistent with data generated from previous studies. Detailed results of the study will be presented at a future medical conference, the company said this morning.
Zeposia is a sphingosine 1-phosphate (S1P) receptor modulator that binds with high affinity to S1P receptors 1 and 5. The drug blocks the capacity of lymphocytes to egress from lymph nodes, reducing the number of lymphocytes in peripheral blood. In ulcerative colitis, BMS said it does not know exactly how Zeposia generates therapeutic results, but it’s believed it involves the reduction of lymphocyte migration into the inflamed intestinal mucosa. In March, the U.S. Food and Drug Administration approved Zeposia for the treatment of adults with relapsing forms of multiple sclerosis. It was the first approval for BMS following the completion of its merger with Celgene.
Samit Hirawat, BMS’ chief medical officer, said the results of the Phase III True North study are encouraging for patients with ulcerative colitis, a chronic inflammatory bowel disease. Hirawat said the trial results shows that Zeposia “demonstrated consistency across key clinical and endoscopic endpoints.” This suggests that the drug could provide a favorable benefit for ulcerative colitis patients should it be approved in this indication.
“At Bristol Myers Squibb, we are committed to researching innovative treatment options that may elevate the standard of care for people living with ulcerative colitis, with a focus on finding solutions that have the potential to transform outcomes for the inflammatory bowel disease community,” Hirawat said in a statement.
Ulcerative colitis is characterized by an abnormal, prolonged immune response that creates long-lasting inflammation and ulcers in the lining of the large intestine. Symptoms, including bloody stools, severe diarrhea and frequent abdominal pain, usually develop over time rather than suddenly. Ulcerative colitis has a major impact on patients’ health-related quality of life, including physical functioning, social and emotional well-being and ability to work. It is estimated that 12.6 million people worldwide have IBD.
Bristol Myers Squibb is also investigating Zeposia for the treatment of moderately to severely active Crohn’s disease in the ongoing Phase III YELLOWSTONE clinical trial program.
