An international clinical trial led by Dr. Brian Feagan of Western University in London, Canada, has found that the investigational antibody vedolizumab is an effective treatment for those suffering from ulcerative colitis (UC) and Crohn's disease (CD) when other treatments have failed. The results of the study called GEMINI are published in the August 22 issue of the New England Journal of Medicine.
Chronic and debilitating diseases, CD and UC are the two most common forms of inflammatory bowel disease and affect more than four million people worldwide. Symptoms may include bleeding, diarrhea, fatigue, weight loss and anemia.
"The publication of these study findings are important since the results support the potential for vedolizumab, if approved, to help manage symptoms in some patients for whom previous treatments have failed," said Dr. Brian Feagan, professor of medicine, and epidemiology and biostatistics at Western's Schulich School of Medicine & Dentistry and director of Robarts Clinical Trials at the Robarts Research Institute. "The data from the GEMINI program suggest that vedolizumab may provide people living with CD and UC an additional option for inducing and maintaining clinical remission."
Takeda Pharmaceutical Company Limited, the largest pharmaceutical company in Japan and a global leader in the industry, funded the trial and has applied to the U.S. Food and Drug Administration and the European Medicines Agency to have vedolizumab licensed for the treatment of adults with moderately to severely active CD and UC.
The GEMINI studies are the culmination of 15 years of work. The molecule involved was initially developed by a London (Canada) scientist, Andrew Lazorovits, doing post-doctoral studies in Boston. He died before seeing his discovery go to clinical trial.
There are four parts to the GEMINI studies, involving 2,700 patients in 40 countries. Both Phase 3 trials, GEMINI I studied patients with UC and GEMINI II focused on patients with CD. Those studies found patient outcomes with the new drug were superior compared to placebo.
"I think the most exciting part of it is, this molecule has the potential to be something quite different than our existing therapies. CD and UC are chronic inflammatory diseases, conditions of the immune system which have a dis-regulated immune response presumably to the bacteria in the bowel. And we don't really know the cause of that dis-regulated response, and so we're forced to treat that with potent immunosuppressant anti-inflammatory drugs. These drugs have side effects because they're broad spectrum. They affect inflammation in the gut which we want them to do, but they also affect other places such as the lungs, the skin and the brain where we don't want to suppress the immune system. The consequence of that broad spectrum activity can be side effects such as pneumonia, skin infections or blood infections," explains Dr. Feagan. "Vedolizumab interferes with trafficking of white blood cells into the gut specifically, as opposed to other places in the body. It has the potential advantage of selective suppression of the immune system and perhaps avoiding the side effects which are a major detriment to patient care."
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