Nexvax2, an immune system-modifying treatment, has received positive results during Phase 1 of trials. It has proven itself to be both safe and tolerable in adults with Celiac Disease.
Fixing The Body's Response To Gluten
Celiac disease is an autoimmune disorder that occurs when a person ingests gluten, a type of protein. It damages the small intestine, causing a variety of digestive problems that might develop into more serious health concerns if left untreated.
People who have celiac disease cannot eat wheat, barley, and rye products. In the United States, it affects 2.5 million Americans.
Nexvax2 works on patients who carry the HLA-DQ2.5 gene, which is responsible for the creation of the recognition protein that instructs the T-cells to flag gluten peptides as threats. About 80 to 90 percent of those who have celiac disease also carry the immune recognition gene.
The vaccine, according to ImmusanT, reprograms the T-cells so that it no longer responds to gluten peptides. This will allow the patients an unrestricted diet and an overall improved health.
Phase 2 Trial And Beyond
The Phase 2 trial will involve patients confirmed to have celiac disease in Australia, New Zealand, and the United States. The participants will be asked to take either Nexvax2 or placebo during the trial period.
Clinical trials usually take around two years, so it would be a while before the vaccine becomes widely available. After Phase 2 is deemed a success, it will undergo another round of clinical testing and then apply for approval at the U.S. Food and Drug Administration.
"This trial is important in establishing clinical proof-of-concept for a treatment that would provide benefit beyond that of the gluten-free diet," said Jason Tye-Din of the Royal Melbourne Hospital and principal investigator. "The gluten-free diet is the only current treatment for celiac disease, but it is onerous, complex and not always effective. Even the most diligent patients can suffer the adverse effects of accidental exposure."
The price of the vaccine has not yet been disclosed to the public as of this writing.