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2022-10-25| Trials & Approvals

Bristol Myers Squibb’s Ulcerative Colitis Treatment Gains Further Validation

by Max Heirich
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Bristol Myers Squibb (BMS) announced an analysis of its Phase 3 True North study evaluating the duration of response following Zeposia (ozanimod) treatment continued for up to a year. Although approved in both the United States and the European Union, the True North program aims to evaluate the continued use of Zeposia in active ulcerative colitis.

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The Ulcerative Colitis Treatment and Other Uses

Ulcerative colitis is a chronic inflammatory bowel which causes inflammation and ulcers within a patient’s digestive tract. Though currently, the direct cause is not understood, factors like an abnormal immune response, genetics, microbiome, and environmental factors play a part in the disease’s development. 

While there is no direct cure, there are a number of treatments available that help patients mitigate the symptoms as well as assist in preventing life-threatening complications from arising. Among these treatments is BMS’ Zeposia.

Zeposia gained approval from the United States Food and Drug Administration (FDA) in May of 2021, with approval from the European Commission following in November of that year. The drug treats ulcerative colitis through the reduction of certain white blood cells (lymphocytes) in the lymph nodes, resulting in a reduction of inflammation. This mechanism of action also works for the treatment of multiple sclerosis, for which the FDA granted approval for Zeposia’s treatment in 2020.

Though having already gained approval, BMS initiated the True North clinical trial program with the goal of analyzing the duration of response following continuous Zeposia (ozanimod) treatment for up to one year. Overall, approximately 86.1% of patients remaining on Zeposia showed no sign of disease relapse after a year.

On the data presented, Bruce E. Sands, MD, MS, Gastroenterologist and paid consultant of Bristol Myers Squibb, said, “Understanding the duration of response after continuous ozanimod treatment is critical, as it can assist in clinical decision making when considering temporary discontinuation of UC treatment in clinical practice. These analyses reaffirm that ozanimodtreatment is effective at helping patients remain relapse-free and suggest that a majority of patients remain relapse-free for up to eight weeks after treatment is interrupted.”

Despite the results reinforce Zeposia’s efficacy in treating ulcerative colitis, BMS is not done with the treatment just yet. The Phase 3 YELLOWSTONE clinical trial is currently evaluating the usage of Zeposia in treating Crohn’s Disease. With an end date set in early 2024, any results, as well as any potential approval, remain to be seen. 

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