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?