Getting “glutened,” or accidental gluten ingestion, is unfortunately familiar to all of us.
The minute that you realize your mistake, either mid-bite or hours later, you more than likely experience a heavy dose of regret, a million “what ifs” in your head, and some pretty damn awful stomach pains.
And even if you don’t notice, it can still affect your system, and the buildup of these kinds of accidental ingestions can do some pretty serious damage.
What if there was a pill that could make those symptoms and their effects on your system disappear? That is exactly what Alvine Pharmaceuticals and Alba Therapeutics are hoping to accomplish.
While these drugs are similar in their goals, they will combat gluten in different ways. Let’s take a closer look at what these companies are doing to help out people with celiac disease.
Since studies show that as many as 70% of celiac patients continue to be exposed to gluten when on a gluten free diet, treatments like these are long overdue for the celiac community.
Alvine Pharmaceuticals are currently developing what may just be the first approved therapeutic treatment for patients with celiac disease, gaining FDA fast track approval and passing clinical tests with flying colors. Their drug aims to break up gluten into teeny tiny particles, so small that they won’t bother your system.
Alba Therapeutics are developing a drug that will potentially patch up holes in the intestines, effectively combating leaky gut and saving you from the agonizing symptoms of accidental gluten ingestion.
We’ve researched all of the details for you and break down what these companies are working hard to bring to the celiac communities.
Alvine is a company focused on the treatment of gastrointestinal and autoimmune diseases. Their current project, ALV003, is an orally administered drug consisting of a mixture of two prototeases designed to degrade gluten, diminishing its immunogenicity. In simpler terms, this means that the drug breaks up gluten into parts so small, they won’t bother your intestines. The drug will reduce or even eliminate symptoms if you accidentally ingest gluten.
Alvine is currently in Phase 2b of clinical trials and are recruiting people diagnosed with celiac disease who have been following a strict gluten-free diet for at least one year to participate. Previous clinical trials have shown that patients taking ALV003 fared better than those taking a placebo when introducing small amounts of gluten into their diet. If the following trials are successful, this unfortunately doesn’t mean that the ALV003 will allow us to eat gluten whenever we want. It is intended for incidents of accidental ingestion of gluten due to things like cross-contamination or other mistakes. Many people with celiac disease are sensitive to even the smallest traces of gluten, and continue to have symptoms after going on a gluten-free diet, making this drug especially important.
ALV003 has been designated as a “fast track” item by the FDA, meaning that it can potentially be approved quite quickly if trials are successful. Study results should be available in the coming year, and approval could take as little as a few years, meaning that the drug could be available as early as 2017. U.S. Doctors will be able to prescribe ALV003 to all patients, regardless of whether or not they have a celiac diagnosis, meaning the drug will also be available to those with gluten sensitivity.
Alba Therapeutics is a Maryland based biopharmaceutical company focused on the development of treatments for autoimmune and inflammatory diseases. Their product aims to combat “leaky gut,” thought to be one of the main precursors which can lead to a cascade of gastrointestinal discomfort and pain. They are successfully moving quickly and successfully through the stages of clinical trials with AT-1001 (larazotide acetate), and we can’t wait for their drug to hit the market.
AT-1001 is designed to combat intestinal permeability, by inducing your body to close the junctions between the cells in your intestines, reducing or even eliminating the symptoms experienced by “leaky gut.” It will potentially be effective at reducing symptoms experienced due to ingesting small amounts of gluten. Clinical trials so far have involved hundreds of celiac patients who have continued to experience symptoms while following a strict gluten-free diet, and the drug has been successful in reducing or eliminating these symptoms. The drug has proven successful when taken before a meal containing small amounts of gluten.
AT-1001 holds fast track FDA recognition, similar to the previously mentioned drug being developed by Alvine Pharmaceuticals. Trials have produced positive results and Alba has moved their drug to stage 3 trials. Stage 3 is the last stage before approval, meaning that Alba may make it to market status before Alvine Pharmaceuticals.
So, hurry up and let’s get this show on the road, Alba and Alvine! I’m sure that we aren’t the only ones who are waiting!