Zeposia Effective in Keeping Ulcerative Colitis in Remission, Phase 3 Study Shows

Zeposia Effective in Keeping Ulcerative Colitis in Remission, Phase 3 Study Shows
Zeposia (ozanimod), an investigational anti-inflammatory medicine, significantly increased clinical remission and mucosal healing in patients with ulcerative colitis (UC), a form of inflammatory bowel disease (IBD), Bristol Myers Squibb announced in a press release. UC is an autoimmune disease characterized by an overproduction of lymphocytes — cells involved in the immune response — in the digestive system, also called the gastrointestinal (GI) tract. Consequently, symptoms such as inflammation, ulcers, and lesions start to appear and can affect patients' quality of life at several levels. Moreover, many individuals with UC show a poor response to currently available treatments, or don't respond at all. Zeposia is an investigational therapy that aims to reduce inflammation and allow the GI tract to heal, by adjusting the immune response. The treatment reduces the number of activated lymphocytes circulating in the GI tract by targeting two receptor proteins: the sphingosine-1-phosphate (S1P)-1 and -5. The True North trial is a Phase 3, placebo-controlled study (NCT02435992) that was designed to evaluate the safety and efficacy of  Zeposia (1 milligram) in the treatment of moderate to severe UC in people who did not adequately respond to prior treatment. The primary goal is clinical remission, or the disappearance of all signs of the disease, as detected by a colonoscopy (endoscopic remission) and based on the Mayo endoscopic subscore (MES), an endoscopy-based scale. Secondary endpoints include clinical response, endoscopic improvement, and mucosal healing. Mucosal healing was defined as endoscopic improvement with histologic remission — remission at the cell tissue level detected by a biopsy. The study comprised two stages: the induction phas
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