A new drug safely and effectively treats patients with the inflammatory bowel disease ulcerative colitis, according to a recent study co-authored by Northwestern Medicine investigator Stephen Hanauer, MD. The results of the phase II clinical trial were published in the New England Journal of Medicine.
The drug, called ozanimod, stops self-attacking immune cells from traveling to the colon.
“Ozanimod is one of a new class of medications that inhibit trafficking of lymphocytes, cells that are important for many chronic immune-mediated diseases,” said Hanauer, who is the Clifford Joseph Barborka Professor of Medicine in the Division of Gastroenterology and Hepatology.
Normally, lymphocytes protect the body against infections and other potentially harmful invaders. But in immune-mediated diseases like ulcerative colitis, Crohn’s disease and multiple sclerosis, lymphocytes damage tissue instead of protecting it. The drug ozanimod treats disease by inhibiting a receptor involved in immune cell trafficking.
“Ozanimod traps lymphocytes in the lymph nodes so they can’t get back into circulation and into tissues,” Hanauer explained.
A previous study showed that ozanimod reduced disease symptoms in patients with relapsing multiple sclerosis.
In this trial, investigators tested the drug in patients with moderate to severe ulcerative colitis. About 400 participants at 57 centers worldwide received one of two oral doses of ozanimod or a placebo for up to 32 weeks. Patients who received ozanimod had a higher rate of clinical remission than the placebo, without significant side effects.
“This new oral agent looks to be a very promising effective and safe medicine for ulcerative colitis,” said Hanauer, who enrolled patients in the trial. “Larger trials are underway to clarify the dose and long-term safety.”
Hanauer said the drug appeals to clinicians because other agents that target lymphocytes have been associated with dangerous side effects, including brain infections and cardiovascular risks, or they require expensive intravenous administration.
This study was funded by Receptos, the pharmaceutical company that manufactures ozanimod. Dr. Hanauer is a paid consultant for Receptos and serves on the steering committee for ozaminod trials in inflammatory bowel disease.