An experimental "vaccine" for celiac disease is set to be tested in a new clinical trial to see if the treatment can protect patients with the condition from the effects of eating gluten - or, in other words, allow those patients to eat gluten safely. It has proven itself to be both safe and tolerable in adults with Celiac Disease.
Celiac disease is a hereditary autoimmune disorder that damages the small intestine when gluten is ingested. This response causes damage to the small intestine and when this happens, nutrients can not be adsorbed properly into the body. In the United States, it affects 2.5 million Americans.
Doctors say the vaccine is designated to target 90% of celiac patients with the HLA-DQ2 genetic form of the disease. The vaccine is specifically created 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. This will allow the patients an unrestricted diet and an overall improved health.
A phase 2 clinical trial typically lasts around two years.
If it is successful in the phase 3 trial, then it would have to apply for FDA approval to become available to consumers in the U.S. The cost of the treatment is unknown.
"This [new] trial is important in establishing clinical proof of concept for a treatment that would provide benefit beyond that of the gluten-free diet", Tye-Din said.
ImmusanT, the makers of Nexvax2, announced they've started phase-two clinical trials for the vaccine, which is created to protect people with celiac disease from inadvertent gluten exposure and, ultimately, could "allow patients to return to an unrestricted diet", ImmusanT CEO Leslie Williams said in a release about the clinical trials. "Even the most diligent patients can suffer the adverse effects of accidental exposure", study researcher Jason Tye-Din, head of celiac research at the Walter and Eliza Hall Institute of Medical Research in Melbourne, Australia, said in an October 30 statement.