New Data Regarding the Larazotide Acetate Drug
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Oct 14 2008

New Data Regarding the Larazotide Acetate Drug

Ever heard of Larazotide Acetate?  Apparently there has been a study going on of a drug called Larazotide Acetate which was designed to prevent the immune system’s negative reaction to gluten. 

As you can imagine, this could be pretty significant for those of us that suffer from celiac disease and follow a strict gluten-free diet, so I wanted to share some of the information I found from the study:

Results from the study showed that larazotide acetate is the first pharmacologic agent to prevent changes in blood mononuclear cell populations (specifically T-reg cells and B Cells) and other markers of immunological change associated with active celiac disease. This data suggests that larazotide acetate offers potential as a future treatment of celiac disease. Results from a second poster presented at ACG showed that larazotide acetate also inhibited the effect of inflammatory cytokines, including tumor necrosis factor (TNF-alpha) and interleukin (IL-4) on intestinal epithelial permeability, in vitro, further suggesting that the product offers potential as a future treatment for inflammatory bowel disease (IBD).

Larazotide Acetate is a novel, non-absorbed peptide currently being studied in Phase IIb trials for the treatment of celiac disease. Larazotide acetate has the potential to become the first approved medicine to treat celiac disease and has been granted “Fast Track” designation from the U.S. Food and Drug Administration (FDA) for this indication.

It sounds like the FDA is expediting this, so hopefully it will get a lot of attention once it reaches the testing phase.   In the meantime, if I get any additional information, I will pass it along here so make sure you are subscribed to our feed.

Article Written by:

Kyle Eslick is the founder of Gluten Free Media, as well as the creator of the popular Celiac Support Groups page. Connect with us on Facebook, Twitter, and now Google+!

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  • Mona

    How long time will it take for the drug to come out on the market? It will be tested in phase three. Is it the last phase? If everything goes well can we get a prescreption from the doctor?

  • http://celiac-disease.com Kyle Eslick

    @ Mona – That is the goal eventually, but there are a number of testing phases. Also, if you live in the United States, it typically takes longer for medications to get clearance here than in other countries, so the wait may be a little longer. :(

  • Dan

    I have just completed being a volunteer for these trials. I will have my results within the next month and will update with the results. Lets keep our fingers crossed.

    • pritam

      my 9 yrs son is suffering from coeliac disease so we are very anxious about the results pls let me know what came out of your results
      pls reply
      anxiously waiting father

  • Mona

    Have you got your test results yet. Do you think it will be possible to eat ordinary food together with the medicine or is the medicine just for “hidden” gluten sources in food.
    Please let me know. I keep my fingers crossed. Have you heard if they will test the medicine in Europe preferably in Sweden?

    • Dan

      Hi Mona. Coincidentally, I requested my results again this afternoon. I will check on any trials in Sweden. This medication is designed to be taken 15-45 minutes prior to a regular meal so you can eat “real” food. The test trial I was in had us take the medication and 2 capsules of gluten. The medication is not absorbed into the bloodstream but does block the absorbtion of gluten. I will keep everyone updated. Dan

      • Mona

        Have you heard anything more regarding the testresults. It’s so exciting. I keep my fingers crossed. Is it Larazotide acetate you have tested?

  • Dan

    Yes it was Larazotide. They are suppossed to be putting the results together the end of August. They should have it all ready by Dec 2009. I cant wait !!! Dan

  • MOna

    You meen the medication will come out on the market in december? If so what a christmas gift. Hope it will come to Sweden. If not I take the first best flight and come to get it!!

    • Dan

      I dont know that it will be available right away but the testing results will be published. The FDA in the states is very slow in actually releasing the drug into the market. I will check however about the possible relaease time.

  • Paula

    Will this drug be available in Canada soon?

  • Chip

    Dan,

    When you participated in the trials, did they tell you that the purpose of the med was to permit celiacs to actually eat wheat, like regular bread, or was it really just to help prevent symptoms in case of a minor contamination to a regular gluten-free diet?

    I didn’t think it was going to allow for full gluten intake.

    • Dan

      My understanding is that was designed to allow you to eat products with gluten. The testing procedure I followed was to take the drug 15 min prior to eating. I then ingested 2 capfuls of gluten.

      • Chip

        How did you feel after eating the gluten capsules? Any typical celiac symptoms?

  • Dan

    Actually, no. During the second phase of the trials, I believe I got the placebo. The effects were mild but I noticed the fatigue came back within 2 days. I won’t know for sure what I got until the test results come back. The amount of gluten they gave me was the equivilent of 1/2 slice of bread.

  • Mona

    I also found an australian company who is trying do develop an medication against glutenintolerance. Please check this websides out.

    http://www.abc.net.au/news/stories/2009/04/13/2541789.htm?site=local

    I become so hapy everytime I read about nwe drugs for gluten.

  • Dan

    I contacted Alba Pharmecuticals just the other day. I have not received a date yet for the results. I would urge everyone to email them and ask about the test results. Keep your fingers crossed ! Dan

  • Dan

    For Pritam and anyone else who’s interested. Your son will probably be concerned about not being able to eat anything. There is a book called Gluten-Free Grocery Shopping Guide. It has many products that although not labeled gluten free, actually are. You can order it at http://www.ceceliasmarketplace.com Good luck

    • pritam

      Dear Dan,
      Thanks for the help.
      I stay in India and the awareness is woefully lackiing
      pls let me know abt the results of your tests as soon as you get them.

    • pritam

      Dear Dan,
      will Alba let you know the results. If yes pls let us know as i am waiting in horrible anxiety for some positive news.
      pls God let this succeed ps pls pls
      pritam

  • Kenny

    Dan,

    Do you know if larazotide is being considered for treatment of only people with Celiac Disease or will it also be used as treatment for Non-Celiac gluten sensative individuals?

  • Dan

    I really don’t know the answer to that. I would urge everyone with questions directly related to the drug to contact Alba. They need to know the interest we all have in this drug.

    • pritam

      Dear Dan,
      any news from Alba . pls let us know . you must be aware of the anxiety we go through
      Pritam

  • Tiffany Jakubowski

    For more information about the clinical trials please visit the website, which can be viewed here.

    It looks like the completion date for this phase of testing is set for Feb 2010 (that is for this phase, not for the drug to be released to the public).

  • Mona

    Does anybody know when it could be launched if succeded?
    Will it be any more testing faste after feb 2010?
    Does anybody knows anything about it.
    I still keep my fingers crossed.

    • pritam

      Dear Mona,
      i think that after IIb there will be phase III trial world wide

  • Dan

    Hello Pritam. I have not heard anything as of today. sorry

  • ABHISHEK

    WELL ONCE THE DRUG IS IN THE MARKET IT WOULD BE PARTY TIME!

    • Tom

      I am a bit concerned that it is taking this long to come out with results. Also, I cannot speak for everyone but if this ever does make it in the market and just allows me to eat what I want instead of making me feel like I did before I became a Celiac then it will be a great disappointment.

  • pritam

    hi Dan,
    how are you
    any news form alba yet?
    pritam

  • Mona

    I’m just curious if anybody know when the result will be published. I check Alba’s homepage everyday for new results, but without any luck. I just hope they will succeed.

  • Tom

    This is what I got back when I sent an email to inquire:
    Thank you for your continued interest in clinical trials in celiac disease sponsored by Alba Therapeutics. Unfortunately there are no ongoing studies at this time. Please check either of the following websites periodically http://www.albatherapeutics.com or http://www.clinicaltrials.gov as information related to ongoing clinical trials will be posted on both websites when available.

  • ctgrusendorf

    See additional testing being done at U of A here.

  • Mona

    I have read that the result would have been published in February, but now it’s mars. Does anybody know how it’s going? I’m afraid something is wrong when it takes so long time.

  • fouz

    when we will know about the results?

  • neil

    I don’t have celiac but my friend does, you guys should be really happy, i’ve been reading about your condition and knowing some chemistry it really really should not be too hard a condition to contain using the latest medical technologies, not only do you know the trigger, you know the location, you know the reason, there are so many ways to tackle it i wouldn’t be surprised if more than one med came out, the problem for the last ten years is the best companies have been working on erectile dysfunction, probably because there are more guys with that problem within the board of directors than gluten, but i’m noticing they have gotten bored with that and are out to solve real problems now.

  • Denize

    I’m waitting for these results too. Does anybody knows something more about this medicin? I’m in Sweden but I would fly to USA in a second if they start selling this:)

  • Chip

    Initial trials are looking promising. Looks like 2012 for an availability date. Details here.

  • Dan

    I’m very disappointed in Alba and this trial. I cannot get any answers either from them or the facility where I participated in this program as to a release date or even the results.

  • Mona

    I have read at the internet that the trial is terminated becuase it was not succeded. I will try to find the article later on the internet. I also read that Shire who was a financer has terminated there corporation with Alba. I have e-mailed them and asked for the results of the trial they did ( I have nor participate in the trial) but I havn’t got any answers and that says all abot the failure. They refer to http://www.clinicaltrial.gov.
    Lucky for us with celiac alvine pharma in the USa and Nexpep in Australia are also doing great research.

    Please check there home page

    http://www.alvinepharma.com and http://www.nexpep.com

    Also check a german company http://www.zedira.com.

  • http://www.glutenfreepromotions.com Tiffany Janes

    If you read the details about the Alba drug, you’ll notice the medication is meant to protect from cross contamination – not something you can take and order a Dominos pizza. That is fine with me as I’d like to not have to worry so much about cc issues when dining out and eating at someone else’s home. However, I don’t want to take rx meds every day, no matter what they can do.

  • http://www.riversideclinicalresearch.com Aaron Cooper

    We are currently conducting the the Alba study for larazotide Acetate for the phase 2B chohort. if you have any questions please feel free to contact me. Dr. Fassano of the CD center in md is the creator of the medication.

    • dr.sonal sonule

      is larazotide acetate available in india?