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2020-10-13| Trials & Approvals

Bristol Myers Squibb’s Zeposia Shines in Ulcerative Colitis Trial

by Tulip Chakraborty
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By T. Chakraborty, Ph.D.

Ulcerative colitis falls under the broad umbrella of chronic inflammatory bowel disease (IBD). This disease is responsible for wreaking havoc in a patient’s quality of life by causing frequent abdominal pain, severe diarrhea, long-lasting inflammation, and ulcers in the large intestine or rectum mucosa. Approximately 1.6 million Americans currently have this disease, and as many as 70,000 new cases are diagnosed every year in the United States alone [1].

While disease-modifying therapies exist, many patients either do not respond to these treatments or provide an inadequate response. On October 10th, Bristol Myers Squibb announced encouraging results from their Phase 3 trial named “True North,” which aimed to evaluate the use of their proprietary drug, Zeposia (ozanimod), as therapy in adult patients with moderate to severe ulcerative colitis [2].

William Sandborn, M.D., Chief, Division of Gastroenterology and Director, Inflammatory Bowel Disease Center at University of California (UC), commented, “The data from the Zeposia True North trial demonstrate patients with moderate to severe ulcerative colitis achieved clinically meaningful improvements in key clinical, endoscopic and mucosal healing endpoints. Notably, the endoscopic and histologic benefits, which can be difficult to achieve, suggest Zeposia has the potential to address the need for a safe and effective oral treatment option for this serious, chronic disease.” [2]

 

Zeposia

Immune cell proliferation and infiltration, leading to mucosal abnormality and inflammation, are key hallmarks of ulcerative colitis. Sphingosine-1-phosphate (S1P) regulates the proliferation, migration, and survival of immune cells through receptor-mediated signaling. Hence, modulation of S1P may be beneficial in reducing immune cell activation in colitis.

Zeposia (ozanimod) is an orally available S1P receptor modulator that can bind to S1P receptors, thereby regulating downstream signaling. Zeposia has been shown to reduce lymphocyte migration, thereby reducing the number of circulating immune cells.

 

True North Trial

True North is a randomized, double-blinded, multicenter Phase III clinical trial. A total of 645 patients were enrolled who either received Zeposia or placebo for 10 weeks for the induction phase and 52 weeks for the maintenance phase. During both the Phases, Zeposia treatment statistically improved the clinical symptoms, endoscopic symptoms, and mucosal healing. The major adverse events that were reported were anemia, headache, and nasopharyngitis. The results will be discussed in greater detail at the UEG Week Virtual 2020.

Mary Beth Harler, M.D., head of Immunology and Fibrosis Development, Bristol Myers Squibb, added, “These Zeposia True North results represent a meaningful achievement for patients living with ulcerative colitis, many of whom have an inadequate response or do not respond at all to currently available therapies. We look forward to working with health authorities to bring Zeposia to this patient population and remain committed to pursuing new scientific advances to help deliver transformational medicines for the gastroenterology community.”

On the contrary, patients who were previously treated with Abbvie’s blockbuster drug Humira did not show statistically significant improvement clinically when treated with Zeposia [2].

The U.S. Food and Drug Administration (FDA) and the European Commission have already approved the drug for multiple sclerosis earlier this year. The drug is also in Phase III clinical trial for the treatment of Crohn’s disease. If approved, this drug will be a relatively new orally available therapy for colitis. Additionally, the safety profile of Zeposia looks to be seemingly better than Pfizer’s JAK inhibitor Xeljanz and Rinvoq from AbbVie.

Editor: Rajaneesh K. Gopinath, Ph.D.

Related Article: Boston Biotech, Alivio Receives Substantial Grant from U.S. DoD, a Second in Two Years

References
  1. https://www.crohnscolitisfoundation.org/sites/default/files/2019-02/Updated%20IBD%20Factbook.pdf
  2. https://news.bms.com/news/corporate-financial/2020/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/default.aspx

 

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