About 1% of the global population suffers from celiac disease, an autoimmune disorder that damages the small intestine when a person ingests gluten. But a new treatment currently in phase II clinical trials may change all that, allowing people with the disorder to include gluten in their diets.
Celiac disease is hereditary and causes the immune system to respond against gluten, which are proteins found in wheat, barley, and rye. For reasons that are not completely understood, ingesting gluten makes the body see the intestine as foreign and attacks it with an inflammatory reaction.
Besides damage to the intestines, the immune response also blocks nutrients from being absorbed properly in the body. Other symptoms include abdominal pain, bloating, diarrhea, constipation, headaches, bone or joint pain and chronic fatigue.
Right now, the only thing a person with celiac disease can do to stay safe is to cut out gluten entirely from their diets. The disorder is so severe that even trace amounts of wheat or rye can trigger an immune response. In the future, however, people with celiac disease might be able to live a normal life thanks to an innovative new treatment.
The difference between celiac disease and gluten intolerance
There is a difference between celiac disease (CD) and gluten intolerance. Things get even more complicated if you add gluten allergies in the mix, which is another distinct condition related to gluten.
Unlike celiac disease, both gluten sensitivity and gluten intolerance do not cause damage to the lining of the small intestine. The body does, however, identify gluten as a foreign invader which triggers the launch of an immune response. Unfortunately, 83% of people with celiac disease are undiagnosed or misdiagnosed because the signs and symptoms with other conditions are so similar.
Nexvax2 is a vaccine meant to protect people with celiac disease from inadvertent gluten exposure and to allow patients to follow an unrestricted diet. The vaccine is specifically designed to work against the HLA-DQ2.5 genetic form of the disease, which accounts for 90 percent of people with celiac.
According to ImmusanT, the manufacturer of Nexvax2, the vaccine is administered in multiple doses that reprogram T-cells to stop triggering a pro-inflammatory response.
In September, the first patient received a dose of a vaccine. Now, Immusant is starting a phase II clinical trial involving 150 participants from the U.S., Australia, and New Zealand. Over the course of 16 weeks, researchers will steadily increase the dose of the vaccine and will follow how patients response to gluten proteins in the gut.
Phase II trials typically last around two years. If all goes well, the therapy can enter phase III, where researchers need to demonstrate that vaccine is at least as safe and effective as currently available options. Finally, if the treatment passes this phase, it may apply for FDA approval so it can be made available to patients in the United States.