Clinical trial findings show promising results for potential new UC treatment

Initial results from two important ulcerative colitis clinical trials were recently released, suggesting that a new treatment option for IBD may receive FDA approval soon. These results have been eagerly awaited by the IBD research community as an important step in advancing a long-term research goal: to develop therapies for IBD based chemicals in the body known as sphingolipids. 

Sphingolipids are involved in many biological process, including the transit of immune cells between different parts of the body. Immune cells need to move around the body to respond to infection; however, in IBD, overly active immune cell transit can lead to inflammation. Reducing immune cell transit is an important opportunity for the development of new treatments for IBD. Many years of work by IBD researchers around the world has led to an understanding of how sphingolipids work in the body and has enabled several drug companies to develop investigational drugs targeting this pathway. Notably, Bristol Myers Squibb has a Phase 3 clinical trial on ozanimod and Arena Pharmaceuticals is performing clinical trials on etrasimod. Both investigational drugs target sphingolipids and would be administered orally.

Clinical trials are studies in which an intervention (like a new drug candidate) is evaluated to determine its impact and potential benefit for patients. Clinical trials are typically the last step before a drug may be approved by the FDA and available to patients. Virtually every drug currently available on the market to treat Crohn’s disease or ulcerative colitis went through the clinical trials process previously.

In June, Bristol Myers Squibb announced that their Phase 3 study of ozanimod had met its target outcomes in patients with moderate-to-severe ulcerative colitis. The study results showed that administration of ozanimod resulted in a significantly increased proportion of patients reaching clinical remission (absence of signs and symptoms of their disease). Detailed study results have not yet been released but will certainly be received with intense interest once made available in academic presentations and journals. In addition, results from Arena’s clinical trial for etrasimod were recently published demonstrating a clinical benefit for the drug. The results also showed that etrasimod reduced the number of immune cells in the blood, which is an indicator of response. The results from both studies are highly encouraging that this new approach may be a viable and important new treatment option. Further studies are ongoing, including clinical trials for Crohn’s disease. 

The Foundation is sponsoring further research on new treatments targeting the sphingolipid pathway. One example is our support of the work of Dr. Susan Schwab, associate professor at New York University School of Medicine, through our IBD Ventures program. Susan, a rising star in the immunology field, has studied the sphingolipid pathway for much of her career and has identified a novel approach that may recapitulate the benefits of prior sphingolipid -targeted strategies, while avoiding potential side effects. Working with NYU’s Office of Therapeutic Alliances, Susan and her team have started the process of discovering new potential drugs based on this novel approach. To learn more about her work, join us for her talk at our virtual innovation conference, IBD Innovate 2020, on November 17 & 18! 

Dr. Gerard Honig is Associate Director, Research Innovation for the Crohn's & Colitis Foundation.