Researchers at University of California San Diego School of Medicine have shown that ozanimod (RPC1063), a novel drug molecule, is moderately effective in the treatment of ulcerative colitis. Results of the Phase II clinical trial will appear in the May 5 issue of the New England Journal of Medicine.
"This new class of immunotherapy drug traps white blood cells in the lymph nodes to prevent their escape into the gut where they cause inflammation," said William J. Sandborn, MD, professor of medicine at UC San Diego School of Medicine and director of the Inflammatory Bowel Disease Center at UC San Diego Health. "In addition to inducing remission in patients, the experimental drug reduced rectal bleeding and healed the mucosal lining of the intestine."
Ulcerative colits is a debilitating autoimmune disease that causes chronic diarrhea. One of the disease's defining characteristics is an abnormal accumulation of lymphocytes or T-cells in the lining of the gut. This activation of immune cells causes inflammation resulting in chronic, painful bowel movements. To counter this activity, ozanimod, a sphingosime 1-phospahte receptor modulator, halts the body's ability to recruit cells for an immune response.
"A one milligram pill of the drug induced clinical remission at week eight," said Sandborn. "Unlike other currently available drugs for inflammatory bowel disease, ozanimod can be orally administered and does not suppress the immune system to the point of increasing likelihood of infection or cancer."
Patients in the study were randomized to ozanimod 0.5 mg, 1.0 mg, or placebo. The most common side effects were anemia and headache.
Other symptoms of ulcerative colitis include intestinal bleeding and weight loss. Bowel obstruction, colon cancer, and malnutrition can also occur, resulting in hospitalization and the possible need for surgical removal of portions of the bowel and colon.
The Inflammatory Bowel Disease (IBD) Center at UC San Diego Health is dedicated to diagnosing and treating people with IBD from around the world. The center's leadership in IBD medical research means patient access to clinical trials for the newest therapies and advanced surgical techniques for the treatment of this challenging condition. Care is provided by a multidisciplinary team of specialists in gastroenterology, endoscopy, oncology, surgery, transplantation and radiology.
Contributors to the study include: Brian Feagan, MD, Robarts Research Institute; Douglas Wolf, MD, Atlanta Gastroenterology Associates; Geert D'Haens, MD, PhD, Academic Medical Centre, Netherlands; Severine Vermeire, MD, PhD, University Hospital Gasthuisberg, Belgium; Stephen Hanauer, MD, and Subrata Ghosh, MD, University of Calgary; Heather Smith, MA, MBA, Matthew Cravets, MA, Paul Frohna, MD, PhD, Richard Aranda, MD, Sheila Gujrathi, MD, and Allan Olson, MD, all at Receptos, Inc.
This study was sponsored by Receptos, the manufacturer of ozanimod.
Disclosure: Sandborn has a past consulting relationship with the sponsor, Receptos.