Today, research has yielded new insights into Crohn’s and treatment methods are expanding. A new vaccine is on the horizon -- one that aims not only to treat the disease, but to cure it.
In the United States alone, over 780,000 individuals are living with Crohn’s disease, a chronic inflammatory bowel disease that affects the entire digestive tract. To this day, it remains a painful, debilitating, and complex disease for which a cure has yet to be found. But now, research has yielded new insights into Crohn’s and treatment methods are expanding. A new vaccine is on the horizon, one that aims not only to treat the disease, but to cure it.
Shedding light on Crohn’s and MAP
Dr. Jonathan Hermon-Taylor, a fellow of the Royal College of Surgeons and a professor of surgery at King’s College in London, has spent many years of his career studying the microbiology in the inflammatory bowel disease development. This has led him to derive to the conclusion that a single bacterium known as Mycobacterium avium subspecies paratuberculosis (MAP) may be the suspected cause of Crohn’s.
In a recent study, Dr. Hermon-Taylor and his research team analyzed tissue samples gathered from over 70 patients affected by Crohn’s. “A major part of our work has been developing a way to detect the organism in human patients. We’ve found that every single Crohn’s patient we studied is infected with MAP” said Dr. Hermon-Taylor. The high prevalence rate of MAP in patients with Crohn’s led him to believe that it is greatly associated with the development of the disease
MAP affects the immune system by weakening the walls of the gastrointestinal tract, thereby making it susceptible to secondary infections and irritants. This, in turn, is what triggers a severe inflammatory response in the intestines and prompts diseases like Crohn’s. Treatments are available to help diminish the response and temporarily alleviate the symptoms; however, unless MAP itself is treated, only the mechanism is treated and not the cause of Crohn’s.
MAP is a robust bacterium, which is why it has not been easy to develop an effective vaccine against it. For a period of 10 years, Dr. Herman-Taylor and his research team have worked to develop a possibly preventative and therapeutic vaccine – one that aims to identify MAP by manipulating the immune system to eliminate it. Although the vaccine will not be able to keep individuals in good health from developing Crohn’s, it may provide relief to patients with the disease.
A dilemma among experts
When it comes to the theory on MAP – more specifically, its role in the development of the disease - experts on Crohn’s disease are somewhat torn.
Dr. Saleh Naser, a professor of microbiology at the University of Central Florida, is optimistic about the theory. 15 years ago, he developed a way to identify the onset of MAP in the blood samples of patients with Crohn’s. He tested a total of 30 blood samples, all of which were seen with MAP.
At present. Dr. Naser and his research team at RedHill Biopharma are working to create an oral antibiotic that aims to specifically target MAP in patients with Crohn’s. The antibiotic, known as RHB-104, is a mix of rifabutin, clarithromycin, and clofazimine. While it passed an international phase III clinical with positive top-line results, additional clinical trials are most likely to be required in order to confirm its lasting effects.
David Graham, the lead investigator of the MAP US Phase III clinical trial, stated that if RHB-104 proves to be effective in healing inflammatory lesions caused by Crohn’s, it could validate the MAP theory.
Other experts in the field, however, are not quite convinced. Dr. Benjamin Hall, a practicing gastroenterologist in Omaha, remains skeptic. “We’ve heard about these kind of silver bullets before. And once the research is done, the numbers usually don’t bear them out. Crohn’s is multifactorial and complicated. I don’t think we’re going to see any one single cause of it [or cure for it]” he said.
Aaron Castens, executive director of the Crohn’s & Colitis Foundation of the Midwest, agrees with Dr. Hall, stating that MAP may be one of numerous microbes that play a role in the development of Crohn’s. “but until more convincing scientific proof emerges, it cannot be described as a primary or the sole cause of Crohn’s disease” he said.
Nevertheless, Dr. Hermon-Taylor remains optimistic about the possibility of a cure for Crohn’s in just a few years. He and his organization are continuously digging into significant clinical findings.
In pursuit of an effective vaccine
According to a study published back in 2014, utilizing the MAP vaccine in cattle has proved to be extremely effective. But the question remains: can it also work for human beings?
Consistent with Dr. Hermon-Taylor’s theory, once the body is rid of MAP, it will no longer trigger the inflammatory response that causes debilitating pain among patients with Crohn’s. “If it does in humans what it did in preclinical animal trials, the vaccine could have significant benefits for people with Crohn’s disease” said Dr. Hermon-Taylor.
Despite all of their efforts, Dr. Hermon-Taylor and his research team have not been able to retain an investment from drug manufacturers. Instead, $1.2 million dollars’ worth of donations have been provided by optimistic patients with Crohn’s and their families to cover the project’s expenses.
The key elements of the MAP vaccine are mechanism of action, efficacy, safety, treatment, and prevention. It has gone through one clinical trial, performed by the Oxford University in the United Kingdom. The trial found the vaccine to be safe for use in healthy human candidates.
Now, a second clinical trial is underway to determine if the MAP vaccine is safe for use in patients with Crohn’s. The results of the trial will be announced in March of 2019. “I’d like nothing better than to deliver good news to Crohn’s sufferers, but right now we don’t know if the vaccine can cure. But from what we know about how the organism presents in humans, the odds are better than an even split, I’d say” said Dr. Hermon-Taylor.
Through research and findings, our knowledge of Crohn’s continues to improve. More effective treatment methods can be expected in the future and hopefully, a cure.