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BioLineRx Clears Latest Hurdle for Celiac Treatment Drug 12/09/2014 - Biopharmaceutical company BioLineRx Ltd., has announced successful final results from its Phase 1/2 study for BL-7010, a novel co-polymer for the treatment of celiac disease.

Photo: Wikimedia Commons--CitrusZestBL-7010 is a new, non-absorbable, orally available co-polymer intended for the treatment of celiac disease. The drug works by sequestering gliadins, effectively masking them from enzymatic degradation and preventing the formation of immunogenic peptides that trigger an adverse immune reaction when people with celiac disease consume wheat.

This significantly reduces the immune response triggered by gluten. BL-7010 is excreted with gliadin from the digestive tract and is not absorbed into the blood.

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The trial results showed BL-7010 to be safe and well tolerated in both single- and repeated-doses, and pharmacokinetic analyses revealed no systemic exposure of BL-7010 in plasma and urine samples.

The company has also settled on a one gram, three times per day regimen of BL-7010 as the optimal repeated dose for an upcoming randomized, placebo-controlled efficacy study set to begin in the last half of 2015.

The absence of systemic exposure will likely support a medical-device classification for BL-7010, which would significantly accelerate its development in Europe.

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9 Responses:

Tina K
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said this on
15 Dec 2014 11:33:59 AM PDT
That's nice, however, I will not use it. Why should I pay to take a drug for the rest of my life just so I can eat gluten-containing foods which really aren't good for you anyway and cause more health problems. Sounds like a lose-lose situation to me.

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said this on
19 Dec 2014 9:02:45 PM PDT
Wrong! - every time you don't prepare everything you eat from scratch you risk a gluten exposure. The amount for a Coeliac reaction is so tiny (one breadcrumb) and the time to repair (6 to 12 months) so long this would help ensure you keep yourself safe. No matter how careful a Coeliac is - this is a very useful product. Cant wait...

Carol August
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said this on
15 Dec 2014 5:31:33 PM PDT
Article worth the time/effort to read it. Perhaps a bit more thorough explanation of the chemistry of this new drug could be helpful to the lay person.
Thank you.

Angela Thompson
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said this on
16 Dec 2014 9:44:39 AM PDT
How long will it be before BL-7010 is approved by the FDA in the US? I need relief from the celiac symptoms. I am ultra sensitive even to a lot of the gluten free products. I have lost down to 112lbs. I weighed 122 almost 9 months ago.

Phyllis Smoker
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said this on
19 Dec 2014 8:08:31 AM PDT
I also am sensitive to a lot of GF foods. I have found out it is the mono and diglicerides that are used in manufacturing. Mono glicerides are OK, but eliminate foods with mono and diglicerides, see if that helps you. It has helped me.

Peter Olins
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said this on
26 Dec 2014 1:32:28 PM PDT
Hi Angela. This drug is still in the early stages of clinical development. The latest study was simply to test for safety at different doses, and to measure if the drug was absorbed by the body. It did not address whether the drug actually works. Sadly, a large majority of drugs that reach this stage of development never reach the market, due to safety or efficacy problems. In other words, while this work is exciting, we are still a long way from being able to celebrate.

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said this on
16 Dec 2014 10:57:23 AM PDT
This is GREAT news!!!

Wayne Boswell
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said this on
20 Dec 2014 6:46:25 PM PDT
I might be interested in such a drug, if it is performing a function that the normal (non-celiac) body performs. I've never read anything as to how the non-celiacs body handles gluten (gliadin). I did appreciate the comment on digicerides, and plan to attempt that. Still looking for answers 20 years after celiac diagnosis.

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said this on
23 Dec 2014 2:28:32 PM PDT
The celiac situation is so complex and there is so much that remains unknown. The danger with a drug to treat part of a problem doesn't allow intelligent consumer choices. For instance for a great many celiacs, the casein in dairy products causes similar symptoms. There is too great a similarity between the proteins in casein, corn even other grains originally thought to be safe for celiacs. So lets say you take a drug that handles gliadin and you think, "Great" now I can eat anything. Not really. You may take chances with wheat because of the drug and never know that you are causing damage because of the other proteins. You are also ingesting a chemical which needs years of trials and after market testing to show the real side effects. There is so much great whole food to eat, why stay so heavily focused on wheat induced happiness?

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I would stick to a very basic gluten-free diet as recommended by Dr. Fasano and other celiac experts. It would not hurt for a short amount of time and might get him through his exams. This is the study about dealing with Trace Amounts of Hidden Gluten (not saying your son has non-responsi...

Yes do follow up with testing, once confirmed we can help you along the road. Other intolerance and allergies are very common with this disease. Lactose is broken down by enzymes produced by the tips of your villi in your intestines, they are normally the most damaged and in some cases just gone....

Please follow the advice of celiac experts and get your daughter tested before going gluten free, Your doctor, like many, is woefully misinformed. You should be tested too (all first degree relatives), even if symptom free, and especially since your mother was recently diagnosed. Learn more a...

We in the UK he takes a pack lunch and have asked for a health plan so wait and see. Not easy when he taking his gcse and he wants to do well. Thanks for the advice

My daughter, who does not have celiac disease, is also in the 11th grade. Since you said exams instead of finals, I assume you are not in the US where a 504 plan can accommodate anyone with a disability (celiac disease counts). This includes tudors, more time to complete tests, etc. Do you hav...