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BioLineRx Clears Latest Hurdle for Celiac Treatment Drug

Celiac.com 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
Rating: ratingfullratingfullratingfullratingemptyratingempty Unrated
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.

 
Rob
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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.

 
muriel
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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.

 
Andrea
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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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Hi! My daughter is 19 was diagnosed at age 16. It took about 12-18 month s for her to fully heal from the damage and feel "normal" again. Also because of the damage done she had reactions to dairy, so you may want to try no or minimum dairy until youre fully healed. Just a suggestion. Hope you start feeling well soon!

Hi yall! New to this blog, but really glad it exists because I have lots of questions. First off, I'm Allie! I'm 17 and newly diagnosed Celiac after about 3 years of searching for answers. I initially went gluten-free on the recommendation of a friend, I felt better in about a month and then my pediatric gastroenterologist had me do the gluten challenge, and my symptoms were the worst they have ever been, and ones I barely noticed before became very present. I did the biopsy and was diagnosed, it's been about 2 weeks and my symptoms are still pretty bad, although my diet has no known sources of gluten or cross contamination. Wondering if anyone has any input on healing post gluten challenge, any tips or how long it took for you would be quite helpful! Thanks

Might want to look into a keto diet, I have UC on top of celiacs and keto is working great Yeah I have major nerve and brain issues with gluten, gluten ataxia with nerve issues and brain issues. Seems to cause my body to attack my brain and nerve system. My brain stumbles fogs, and starts looping, the confusion causes me to become really irritable, I call it going Mr Hyde. Like my mind will start looping constantly on thoughts and not move driving me literally mad, or it used to. Now days it is primary the numbness anger but the gut issues and sometimes random motor loss limit me motionless to the floor now days for the duration of the major anger effects. Used to be a lot more mental then painful gut. I did a mental trauma post on it on while back where I came out about all my mental issues with gluten.

^^^^^^ good info, tips and tricks^^^^^^^^^ yes, crumbs will make you sick. also, breathing flour/pancake mix, etc that is in the air because eventually, you're going to swallow some.

Hello I was diagnosed Dec 15 of last year and went totally gluten-free the next day. I actually got worse before I got better - it's a steep learning curve - but now, 4 1/2 months later I'm finally seeing improvement. Hang in there.