According to a story from Pharma Advancement, Bristol Myers Squibb recently announced encouraging findings from a phase 3 clinical trial. This study was testing its drug ozanimod (marketed as Zeposia) as a maintenance and induction therapy for patients living with ulcerative colitis considered moderate to severe. The therapy was able to satisfy all primary endpoints as well as many secondary endpoints, suggesting that ozanimod could be a useful treatment option for these patients.

About Ulcerative Colitis

Ulcerative colitis is a long term condition which is characterized by the appearance of ulcers and generalized inflammation of the rectum and colon. The exact cause of the condition remains a mystery, but there do appear to be some risk factors, such as family history, diet, and exposure to the medication isotrentinoin. Smoking appears to have a slightly protective effect. Symptoms can include anemia, bloody diarrhea, weight loss, fever, and abdominal pain. They tend to appear in a relapsing-remitting pattern. In severe disease there is a risk of serious complications, such as megacolon or inflammatory disease in other parts of the body. The risk of colon cancer is also elevated. Treatment may include dietary changes, medication to control inflammation, and, when complications appear, surgery. To learn more about ulcerative colitis, click here.

Study Results

At ten weeks, the drug produced clinically meaningful and statistically significant remission in 18.4 percent of patients (vs 6 percent placebo), and this jumped to 37 percent (compared to 18.5 percent) at 52 weeks. 47.8 percent of patients treated with ozanimod saw a clinical response at ten weeks compared to just 25.9 percent in the placebo group; at 52 weeks, these numbers rose to 60 percent versus 41 percent, respectively.

This phase 3 trial tested a 1mg dose of ozanimod in a total of 645 patients with moderate to severe disease that were not responding sufficiently to other treatments. 60 percent of the participants were male and the mean age of the participants was 42 years.

A significant portion of patients living with ulcerative colitis still have trouble controlling their disease symptoms and achieving durable remission. The results from this study indicate that ozanimod could be an effective, orally available therapy for patients with severe disease.