Alvine Pharma’s Celiac Drug Hits the FDA’s Fast Track

If I had a magic pill that let me eat gluten, the first thing I'd want is a proper NY slice of pizza.

We always try to keep you up to date on the latest news about therapeutic treatment of celiac disease / gluten intolerance, which means we talk about a company called Alvine Pharmaceuticals every now and then. Today is one of those days!

For a brief refresher, have a look at our coverage of their Phase 2a trials back in 2011. The trials cover their drug, boringly named ALV003. Behind the boring name, though, are some interesting things. The FDA seems to agree, and so they’ve agreed to designate the drug as on the “Fast Track”.

What does this mean, and what is this maybe-magical-celiac-medication?

According to the press release‘s description of the drug:

ALV003 is an orally administered mixture of two recombinant gluten-specific proteases, a cysteine protease (EP-B2) and a prolyl endopeptidase (PEP). ALV003 targets gluten and degrades it into small fragments, which, in vitro, diminishes its immunogenicity.

In plain-speak, what this means is that ALV003 would get to the gluten after a person with celiac disease ate it — but before it triggered a celiac response. If the molecules can be broken down enough, research indicates that they can pass through a person’s digestive system as normally as any other gluten-free item. This is, in essence, the same science that allows for some gluten-free beers to be brewed using barley. It’s just that the process of breaking the gluten apart happens in a big vat with beer, and in the person with ALV003.

Also according to the press release:

Under the FDA Modernization Act of 1997, the Fast Track program was designed to facilitate the development and expedite the review of drug candidates intended to treat serious or life-threatening conditions, and that demonstrate the potential to address unmet medical needs. With a Fast Track designation, there is an opportunity for more frequent interactions with the FDA during clinical development and for the possibility of priority review, which can reduce the time required for FDA review of a New Drug Application.

So, in essence, Alvine Pharmaceuticals still has oodles of research to do and trials to complete before they can decide whether or not ALV003 can be made for the public. However, the FDA has indicated that they will look at this research more quickly than they might for a less-intriguing, important, or promising treatment.

Will we see ALV003 on the shelves or in our doctors’ offices any time soon? Who knows? Certainly even in a best-case scenario it’s years away — and this is a good thing, because a gluten-free diet seems to be working just fine for most of us and it would be awful to see a drug get rushed out that was more harmful than helpful — but there is still hope.

We’ll keep you up to date as more news of Alvine’s Phase 2 and 3 trials gets published. In the meantime, if your doctor gave you a pill and told you you could eat anything you want for a day: what would you eat?



15 thoughts on “Alvine Pharma’s Celiac Drug Hits the FDA’s Fast Track”

  1. It would be a toss up – either a serious slice of NY style pizza (forever my favorite) or an authentic French pastry – pain au raisin.

    Geez. That pizza photo made my mouth water.

  2. Nice commentary – balancing desire for speed with need for safety. And yes, that pizza slice looks great (and a (very) small part of why I moved back to NYC before I was diagnosed).

  3. “Against the Grain” brand baguette bread is great! It comes frozen. Thaw for 20 seconds in the microwave, put in the oven for 5-10 minutes and you have yummy, crusty bread. The inside texture is more like a pop-over, but you can make sub-sandwiches, bruschetta, cheese bread, etc.

  4. I have had my list for a while, waiting for a pill to get approved:
    -Real Chinese food – P F Chang’s is not really Chinese – I mean Chinatown, Chicago food – pot stickers, shu mai, dumplings…..
    -my home made rugelach – it is my favorite of allthe cookies I baked before going gf
    -a good rye break from a Polish bakery, when I was a kid my mom would send us to the bakery and I would eat the heel on the way home. No gf bread can ever taste that good or have that chewy crust.

  5. I’m a simple girl, french bread with real cold butter, real oat nut whole wheat toast with peanut butter and pizza. I could definitely get fancy but just the basics are what I miss most. It sure would be nice to indulge sometimes. sigh, one can dream at least.

  6. OMG! What would I not eat is the better question. I would have a bite of each of these: a Cheeseburger, Deep Dish Meat Lovers Pizza, Sub Sandwich, Hot Dog from Skins, Chicken Dumplings, Quiche Lorraine, Breakfast Ring, Gravy Biscuit from Hardees, Cheesecake, Oreo Cookies, a real Peach Cobbler, Krispy Kreme Doughnut, Apple Spice Cake, Bo Berry Biscuit from Bojangles…just to name a few!

  7. I’ve been GF for almost 8 years and I’ve been the heaviest I’ve ever been for the last 2 1/2. Jeff, please don’t perpetuate the myth that gluten-free = weight loss.

  8. Oh definitely Krispy Cream maple iced cream sticks! Then a loaf of warm Ciabatta bead with Olive Gardens fettucini alfredo!

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