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In Celiac Disease and the Quest for a Cure Part 1, we discussed Nexvax2. This vaccine could one day offer a real cure for celiac disease by “teaching” our immune systems to tolerate gluten.

Today, we’re going to look at a company that’s taking a completely different approach.

California-based biotechnology company Alvine Pharmaceuticals has been hard at work on their leading candidate for celiac disease treatment. The newest version of this therapy is called ALV003, which uses an enzyme-based approach to break down the harmful components of gluten.

See, humans do not break down the massive gluten particle as completely as it breaks down smaller, simpler food particles. These partially digested gluten peptides make their way into the human gut and, in a normal person’s body, pass through without a problem. However, people with celiac disease suffer from a “leaky gut” which allows these molecules to pass through the cellular gaps in the gut and into the blood. Once there, the immune system goes into a frenzy, attacking the gluten and damaging the tissue around it.


Getting to the Gluten before the Gluten Gets to You


So because humans lack the ability to completely break down this massive protein, scientists have turned to another source.

ALV003 is a combination of ALV001 and ALV002. ALV001 is an enzyme produced by the glutinous grain barley and is known as EP-B2. ALV002 is an enzyme derived from bacterial sphingomonas capsulata and is known as SC-PEP. Instead of trying to break down the entire gluten molecule, these two enzymes go after the glutamine and proline residues on the molecule, which causes it to break down into smaller fragments that are not recognized by the immune system as gluten.

When combined into ALV003, the results have been promising. Alvine successfully completed a Phase IIa clinical trial in 2010 (Phase IIa studies tend to focus on human safety, while Phase IIb studies focus more on therapeutic effectiveness). Adding more momentum to Alvine’s progress is the fact that in May 2011, the U.S. Patent and Trademark Office approved four patents for Alvine’s Stanford University-based researchers. This significantly increases Alvine’s ability to raise money and conduct further research and clinical trials.

While the intended final ALV003 product would be an orally administered drug to be taken with glutinous food (similar to how people with lactose intolerance take Lactaid), there are further possibilities for this promising therapy. Eventually, something like ALV003 might be added to the food itself, so that you wouldn’t even have to take the pill with food.

Who knows – maybe one day these enzymes will be mandated by the government to be added to breads. If that sounds unreasonable, remember that it already happened with folic acid.

ALV003 aims to break down gluten while it’s still in the stomach so that by the time it reaches your intestine, where it can potentially slip through your “leaky gut” and cause damage, it has already been degraded. This is where Alvine is headed, and it looks like things are moving right along for them.


A Third Path?


Some of you may have heard of Dr. Alessio Fasano. Well if you haven’t, he is the authority on celiac disease. His team is taking a completely approach to finding a cure for celiac, and they may be the closest of them all… Well at least the FDA thinks so.

We’ll discuss what they’re doing in the next installment of Celiac Disease and the Quest for a Cure.


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