A new experimental treatment could change the way those suffer from the celiac disease. If clinical trials prove positive, those that are put on strict dietary constraints could be offered a new hope that would make gluten tolerable for those that suffer.
Nexvax2, the treatment in question, has the ability to change the immune response people have to gluten. The adjustment will no longer create a body response that is harmful and inflammatory.
Celiac disease is defined as an autoimmune disorder that involves the harming of the small intestine as a result of gluten consumption.
Currently being tested, Nexvax2 looks to provide people with immune recognition genes that equate to approximately 90 percent of the celiac patient population. This information is according to ImmusanT, Inc., the Massachusetts-based company leading the charge on the vaccine.
Testing currently includes a phase 2 clinical trial that is using United States patients in Australia. The average length of a phase 2 clinical trial is two years.
At the conclusion of the trial, a phase 3 clinical trial would be the next step for the treatment in order to prove that it provides the same level of safety and effectiveness as treatment options that are currently available.
A successful clinical trial at phase 3 would then mean Nexvax2 must apply for FDA approval in order reach consumers within the U.S. The treatment’s cost is currently unknown.
If it is approved, the treatment could provide an option for Americans with celiac disease who’s only current treatment option is a strict gluten-free diet.
“Further research and results are awaited, but if the therapy does work, it has the potential to enable patients to return to a normal diet and improved health,” said Dr. Dean Railey, a gastroenterologist in Sunrise, Florida, who is not affiliated with Nexvax2. “It’s really tough to go gluten-free, you have to read every label and know exactly what you’re eating at restaurants.”
To learn more about celiac disease, Dr. Johanna Kreafle answered five questions about the disease. Kreafle is an emergency medicine physician at the Carolinas Medical Center in Charlotte, North Carolina, and a member of the ABC News Medical Unit.
1. What is celiac disease?
Celiac disease is a hereditary autoimmune disease that causes the body to mount an immune response against gluten, which is a combination of proteins found in wheat, barley and rye. This response causes damage to the small intestine and when this happens, nutrients cannot be adsorbed properly into the body.
2. Do all people with “gluten intolerance” have celiac disease?
No. Some people have non-celiac wheat sensitivity, which has similar symptoms to celiac disease but they do not test positive for celiac disease. And it is not confirmed that gluten is the culprit triggering the immune reaction in these people — it may be another protein or antigen.
3. What are the symptoms of celiac disease?
There are many symptoms but the most common are abdominal pain, bloating, diarrhea, constipation, headaches, bone or joint pain and chronic fatigue.
4. How are people diagnosed with celiac disease?
Two steps: screening and diagnosis. You should always consult a physician to ensure proper diagnosis.
Screening: Blood tests to screen for celiac disease antibodies. If the blood tests suggest celiac disease, your physician will recommend a biopsy of your small intestine to confirm the diagnosis.
Diagnosis: Biopsy of your small intestine during an endoscopy looks for damage to your small intestine consistent with celiac disease.
5. What treatments are available for celiac disease?
Currently, the only treatment available for celiac disease is lifelong adherence to a strict gluten-free diet. This means avoiding foods with wheat, barley and rye.