What’s Up with the Celiac/T1 Diabetes Pill?

I’m not sure how I missed this one last Spring, but a certain Dr. Alessio Fasano of the University of Maryland Center for Celiac Research in Baltimore helped kick off Celiactrunk some super-exciting research on a pill that could “put an end to off-limits foods for diabetics and celiacs.”

The pill, which works by decreasing the permeability of the intestines, is being developed by a spin-off startup company called Alba Therapeutics, where Dr. Fasano serves as a board member. 

The capsule they’re designing is taken 20 minutes before each meal, so that the active ingredient, AT-1001, can be slowly released in the intestine, where it inhibits the action of the protein zonulin. Zonulin regulates intestinal permeability, and is apparently overproduced in people with auto-immune diseases like diabetes and celiac disease. Taking AT-1001 should restore the barrier function of the intestinal wall.

One original story also quoted Fasano as saying, “If everything goes to plan, we could have a product on the market by the end of 2006.”  Wow! The anti-gluten intolerance pill we’ve been waiting for! So what’s up with this wonder pill?

I reached Dr. Fasano by phone on Monday to get the scoop.  (A pill like that could change mine and many thousands of lives, of course.)

“I don’t know where they got that information about a product this year.  That was a misquote,” Dr. Fasano says. “What I told them was, we could have clinical trials underway by the end of this year, and we’re actually a little ahead of schedule there.”

In fact, in current Phase 2 studies, more than 70 celiac patients are testing the pill that will hopefully offset the effects of this disease — a chronic intolerance to gluten, which requires a lifelong avoidance of products made with wheat (a humungeous pain in the ass, to say the least).

Did you know that nearly 1 in 133 Americans has celiac disease?  It’s also chronically underdiagnosed in Type 1 diabetics (since the two are often paired — witness: me)  Check out more info at the University of Maryland Center for Celiac Research.

“I believe that it is going to be the case that restoring the intestinal barrier will mean that those prone to developing diabetes or celiac disease can eat a normal diet,” Fasano has said. The next round of research should be with Type 1 diabetics, he tells me.

OMG, sign me up. This is huge. A potential life-changer for sure.

But as usual, “time to market is totally unpredictable” based on the outcome of the current studies, Fasano says.  Still, Alba’s pill is worth keeping an eye on because this remedy is in “the most advanced stage of research” of any other treatment of its kind (!)

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7 Responses

  1. Michael Park
    Michael Park December 7, 2006 at 9:21 am | | Reply

    Excuse my ignorance, how does intestinal permeability effect diabetics, and what are the foods that are off-limits due to it?

  2. AmyT
    AmyT December 7, 2006 at 9:39 am | | Reply

    I believe the issue with diabetes is how quickly carbs will be broken down into sugar. If they are absorbed more slowly, this will be a huge help in avoiding blood glucose spikes.

  3. Scott
    Scott December 7, 2006 at 10:41 am | | Reply

    Its my understanding that Alba’s work will impact several autoimmune diseases not just T1DM and Celiac, as the medicine(s) they are developing supposedly blocks the trigger(s) of the body’s mistaken immune system. Most treatments for autoimmune disease today only treat the symptoms, not the disease itself.

    Based on clinical trial results, I think they are a bit further ahead on their work on celiac, but this would indeed be a novel way to address a variety of autoimmune diseases. While some have complained that this would not meet their definition of a “cure” because it would require daily maintainance treatment, and not a one-time cure. From my perspective, if all I would need to do is pop a pill, I’d trade that for this carb counting and inability to precisely dose with insulin in a second.

  4. Felix Kasza
    Felix Kasza December 7, 2006 at 12:34 pm | | Reply

    > Did you know that nearly 1 in 133 Americans has celiac disease?

    No, I didn’t. Neither does emedicine.com:

    “In the US: The frequency of celiac sprue in the United States is relatively low, about 1 case in 3000 persons.”

    Even for high-incidence populations, emedicine.com claims only that “celiac sprue affects 1 in 250-300 individuals.”

    Source: http://www.emedicine.com/med/topic308.htm

    Cheers,
    Felix.

  5. AmyT
    AmyT December 7, 2006 at 2:29 pm | | Reply

    Hmm, Felix, a number of other organizations report 1 in 133. See:

    http://www.celiac.com/st_prod.html?p_prodid=1376

    and

    http://www.usatoday.com/news/health/2006-11-01-celiac_x.htm

    for just a few. I guess this just goes to show how statistics can vary.

  6. cevenol
    cevenol December 7, 2006 at 11:49 pm | | Reply

    Hi,

    in fact, the serological prevalence of CD is increasing extensively T/O the world. I recently obtained the abstracts of the last CD symposium in NY. the data are alarming…and don’t know why the gvt does not make any move toward more information to the GP and public.gluten is everywhere.
    the seroprevalence is around 1% in developped country and as high as 7% in sarahwhi population, 2% in mexico etc…
    fasano pills…hum, the last clinical data are disapointing as i understand because gliadin is getting inside the cell throgh transcytosis! the AT1001 product does not act as efficiently and I am afraid there are some business interest in this story (see the recent “abarxis affair with a derivative of taxol!).
    instead have a look at F koning results with his pill..h ereview the results in a recent issue of trends in biotechnology (scientific paper)…I have anxisouly waiting for any results from clinicla trials..supposed to be start shortly!
    so fingers cross and maybe we can have once more a slice of pizza

  7. Felix Kasza
    Felix Kasza December 9, 2006 at 5:38 pm | | Reply

    Hi Amy,

    and thanks for the reply. I dug up the original study the 1:133 number seems to be based on (PubMed has an abstract, PMID 12578508). The authors define CD as the presence of human transglutaminase antibodies (IgA cat.) and ignore the presence (absence, rather) of clinical symptoms. That would indicate one possibility why the numbers vary so wildly.

    Thanks again,
    Felix.

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