Drugs for Celiac Treatment See Progress
A clinical trial, designed to test the new drug, NexVax2 has started and the first participating patient has received their vaccine. In addition to that, CypCel has been tested, ZED 1227 has moved to phase 2 in clinical trials, and Larazotide Acetate is close to becoming the first drug for celiac disease to reach phase 3 in clinical trials. We covered the initial introduction of these drugs to clinical studies and testing, and we couldn’t be more thrilled to have the opportunity to report their progress. While this is all very exciting and seems to be moving forward at a remarkable pace, it will still be at least five years before any drug will become available to the patients. That being said, let’s take a closer look at the progress that has been made thus far in drugs for celiac treatment.
CypCel
The Mayo Clinic recently completed a study to test CypCel, a simvastatin-based diagnostic test, to see how effective it would be in measuring the intestinal damage in those with celiac disease.
According to Beyond Celiac, “Simvastatin has the unusual property of being highly metabolized in the small intestine by an enzyme that is expressed on the villi lining the intestine.” Two blood samples were taken from each participant after they were given a tablet with the medication. A direct relationship was found between the concentration of the simvastatin in the participants’ blood and how healthy their villi were. Healthy villi led to less concentration of simvastatin in the blood (due to the enzyme on the villi lining speeding up the metabolizing process), while the reverse was found for damaged villi.
This discovery could lead to an easy way of monitoring the success of treatment, such as the gluten-free diet, on someone with celiac disease. It could also lead to a less invasive testing protocol for celiac disease. The current process for diagnosis of celiac disease in the United States is genetic blood tests, followed by an endoscopy and biopsy to determine if damage has been done to the villi. This could eliminate the need for a biopsy in order to determine if the villi are damaged.
Jennifer Sealey Voyksner, chief scientific officer of ImmunogenX, the California-based company focused on finding a celiac treatment that is responsible for CypCel said: “We are very excited to be developing this new diagnostic method, which serves as an alternative to an expensive and invasive biopsy.”
NexVax2
NexVax2, developed by ImmusanT, is a vaccine to protect those with celiac disease from cross-contamination damage. It’s currently in phase 2 of clinical trials and is being tested to see if the benefits of the vaccine do, in fact, outweigh any risks. A phase 1 study done earlier helped to determine the proper dosage for each vaccine. ImmusanT’s end goal is to develop a vaccine to eliminate the need for a gluten-free diet in those with celiac disease, thus providing a complete celiac treatment.
The chief medical officer of ImmusanT, Ken Truitt, M.D. said: “Through this study we anticipate making new insights that will further our ability to demonstrate specific suppression of the immune response to gluten epitopes and associated effects of celiac disease.”
Larazotide Acetate
This drug is expected to begin Phase 3 clinical trials by the end of this year, becoming the first celiac treatment to do so. This drug was created to decrease “intestinal permeability and [regulate] tight junctions between intestinal cells,” according to Beyond Celiac. “This so-called ‘leaky gut’ is thought to be the gateway to many autoimmune diseases, including celiac disease.” It could hopefully help those who still experience symptoms while maintaining a strict gluten-free diet.
ZED 1227
The idea behind ZED 1227 is that it would block an enzyme that reacts with gluten, making “them more recognizable to the cells that cause destruction of the nutrient-absorbing villi in those who have celiac disease,” according to Beyond Celiac.
They added:
“The enzyme, tissue transglutaminase (tTG), makes the harmful gluten protein that passes through the intestinal lining more palatable and more recognizable to T-cells. TTG has a direct role in the gut lining where it enhances the inflammatory activity of gluten. By blocking tTG, ZED 1227 would prevent the immune response that drives celiac disease”
They’ve now entered into a Phase 2 clinical study, designed to determine the effectiveness of the pill, as well as the proper dosage.
Despite the long wait expected for these drugs to make it to the market, this news is very exciting. Scientists and researchers are showing a new interest in celiac disease, driving further research being conducted at a much faster pace than ever before. A celiac treatment other than following a strict gluten-free diet may very well be on the horizon, something of which those with it only dared to dream.