Future of IBD Meds?

DS just asked me if I really think there will be a cure for Crohn's soon. I said yes, hopefully in his lifetime. He's only 13, so pretty good odds, right?

Then he asked what new meds are being worked on. Does anyone have a quick list? Doesn't matter if its pediatric or not. By the time some come out he'll likely be an adult anyway. I just want to tell him something... give him some hope.

Q-Biologics (or some similar name) is current running a trial for SSI:

http://www.crohnsforum.com/showthread.php?t=36119


Recently read of another trial for Traficet-EN. I know virtually nothing about it other than it's currently in Phase III trials - here are two links:

http://www.crohnsforum.com/showthread.php?t=10424
http://www.chemocentryx.com/product/overview.html


I believe stem cell transplant has also had success. There is a member here, effdee , who posted his experience in going through this and, at his last post, two years post transplant, he continues to do well.

http://mypsct.blogspot.ca/

I'm sure there are others but these are the only ones I know.

But, great question!! I'm looking forward to seeing more answers!!

Great question !
Thanks for the links you provided Tess

I'll also be looking forward to more answers, as we have no idea where we're going next if Remicade doesn't do it for Gab.

How about Stelara? Or Vedolizumab?
I know there is a new biologic, Xeljanz (tofacitinib, that's a pill and was just approved for RA. According to my daughter's rheumatologist, it will be studied in Crohn's and Ankylosing Spondylitis too. There's also supposed to be a drug that "blocks" (that's probably not the correct term) IL 17 that will be approved in the next two years for Ankylosing Spondylitis and I think (but I could be wrong about this one) Crohn's.

http://www.medscape.com/viewarticle/763862

ibd drugs in the pipeline by medscape

Mayoclinic
http://www.mayoclinic.org/medicalprofs/ibd-pipeline-drugs-pudd0412.html


ccfa stuff
http://online.ccfa.org/site/DocServ...ides_New-Drugs-and-Treatments.pdf?docID=17225

When Brian was 6 yrs old We were told there would be a cure in 10 years...recently I said to the GI...well, he's almost 14...cure coming soon? She said, 10 years. UGH

I have high hopes for the SSI by Q Biologic. I'll attach a news story about it from a couple of months ago.

http://globalnews.ca/news/606100/new-clinical-trial-for-Crohn's-disease/

Maya142 said:

Or Vedolizumab?

Click to expand...

Completely failed in trials, in the first studies it barely beat out placebo, but it was statistically insignificant, in later trials it actually did worse than placebo.

Tell me if the huge pictures bother btw, unless you have access to journals it won't show up in a link. So I can't just "link it".

And I can't really make it smaller because the text loses too much sharpness then.

Vedolizumab seems very promising for UC, not for CD. I'm very hopeful about the Qubioligics treatment as well. Hope it's not too long before it's accessible (results so far are quite promising).

I would say something about the QuBiologics but they're very unspecific about what is being injected, at least they were, haven't bothered to check so maybe someone can tell us.

they use a strain of e.c not sure which 1, either way, it supposably stimulates new macrophages in the adaptive immune system.

kiny said:

I would say something about the QuBiologics but they're very unspecific about what is being injected, at least they were, haven't bothered to check so maybe someone can tell us.

Click to expand...

I did the first steps to be in the study, they've sent me the consent form in which they stat it is E. Coli, not alive. I'm now skeptical as to why such a specific substance should even work at all. I understand their rational, but I have my doubts.

Kiny we were considering this for our daughter and have spent a lot of time talking to them - to be honest, I can't remember (an ecoli vector but I can't remember what it contains and tbh it's over my head). But considering it's been cleared for trials and so far there haven't been any serious side effects and there aren't likely to be (I believe it's been used extensively by them in cancer patients) - based on that, if it works and considering the options I would take it. Having said that, nowI'm curious as well.

Yeah, something about microphage production - they site NOD2/ATLG extensively in their information package (both of which my daughter has, so I am very keen to try it).

Hi kill colitis, could you please elaborate on the NOD2 etc? I Havnt even looked into that for me, those are genes associated with cd?

NOD2 is associated with CD specifically higher chance of fistulizing/stricturing disease at least according to Jack's GI. Can't remember about ATLG I would have to look at his prometheus prognostic again as it seems it was on there. Will have a look when I get home as I'm curious now as well

Don't want to hijack this but NOD2 is highly correlated with CD (and my daughter has a "UC" diagnosis) and there are three NOD2 SNPs which they've studied - one is correlated with stricturing disease but the others are not. They seem to be correlated with ileo colitis but again there's some research which shows that certain one of these is not. Even though it's highly correlated with CD there's not been a ton of research on it, more like subsequent studies referencing previous ones.
ATG is weaking correlated with CD, though there's been quite a lot of research on it. It's not a mutation but a polymorphism.
One reason the Qubiologics therapy resonates with me is because it references these genes and seeks to address them, so it's well worth a shot for my daughter if she can hang on to her colon until we can get it.
Joshuaa, I wouldn't worry too much about the genetic stuff since you already have a CD dx. It's particularly relevant to me because of the UC dx. This info has persuaded me to try to treat as aggressively as possible (currently on 4 weekly remi at 10mg/kg) instead of going to surgery (my preferred option if it were clearly UC. All other tests including three sets of scopes, biopsies etc say UC).
http://www.researchgate.net/publica...lasma_membrane_at_the_site_of_bacterial_entry

Jacqui, Is the ATLG from the prometheus test in reference to the NOD2 gene? We got results from this test in 'he doesn't have antibodies to humira' but I haven't actually seen the report.

It's the prometheus prognostic test, different test then testing for antibodies. It tests for genetic markers/mutations for Crohn's Jack had it done even though we knew he had Crohn's as his GI felt he was missing something or there was something we were not seeing and wanted to get a bigger picture of his Crohn's.

We were told there would be a cure in my son's lifetime too.

It was explained that it would happen for certain "sub types" of crohn's first. A Dr. at our GI clinic said they are starting to type crohns and get the treatments more specific for disease course. Anyone have anymore info on this? I apologize if this info is in the links above, I haven't had a chance to read them all.

I didn't see LDN listed in any of the links. Is it not considered new for crohn's treatment? Are there any trials going on for LDN?

TNI BioTech has acquired the patent rights to LDN and are planning a Phase III trial but I have not seen any further information on it. Here's a blurb from their website

"TNI BioTech is extremely pleased to acquire the exclusive rights to low dose naltrexone and other opioid antagonists for the treatment of inflammatory and ulcerative diseases of the bowel," stated Noreen Griffin, CEO of TNI BioTech. "We believe that low dose naltrexone has the potential to provide significant relief to those who suffer from Crohn's disease or other auto-immune disorders of the bowel." Low dose naltrexone has already been evaluated in two randomized placebo-controlled phase II trials, one for adult patients with Crohn's disease and the other for children with Crohn's disease by Dr. Jill Smith. Naltrexone in low dose has been well tolerated in almost all patients, and it showed significantly greater treatment efficacy than the control group in both trials. TNI BioTech is now planning to meet soon with the FDA to design and implement pivotal phase III trial(s) for treatment for patients with Crohn's disease using naltrexone in low dose. A platform immunomodulatory technology, naltrexone in low dose also is expected to be clinically tested for treatment of other immune-mediated or immune-deficient diseases, for which the company has previously acquired additional patents.

Click to expand...

Here is another more recent blurb from their website so it looks like they are moving forward hoping for early 2014 according to article

TNI BioTech Receives Meeting Minutes from FDA Type C Meeting on Naltrexone HCL for the treatment of Crohn's Disease
BETHESDA, MD., July 23, 2013 – TNI BioTech, Inc. (OTCQB: TNIB) is pleased to announce that on July 17, 2013 the company received the official minutes from its recent Type C meeting held June 26, 2013 with the Division of Gastroenterology and Inborn Errors Products regarding the clinical and regulatory aspects of the proposed Phase III development program and future 505(b)(2) application for Low Dose Naltrexone (LDN) in the treatment of adults and pediatric patients with Crohn's Disease. TNI BioTech, Inc. also received official written responses regarding CMC and non-clinical aspects of the LDN development program.

Click to expand...

LDN new.... I guess it depends on your point of view. Here we are... August, 2013. I've successfully held my disease (I'm lucky enough to have both Crohns and Ulcerative colitis) at bay since November of 2007... so, essentially.. 5 3/4 years. based on a study posted in the American Journal of Gastro-enterology early in 2007 (June or July, I think).

There have been 2 studies on treating IBD in adults with it... and the results mirrored each other... very positive, high success rate, either little or no side effects (minor ones, sleep disruption, feeling wired, vivid dreams... I had this last one... unfortunately, it didn't last long... imagine, I'm talking about a 'side effect' that I regret having passed.. as for the others... nuisances, pains in the proverbial.. but none of any life threatening note... you know what I mean? The sort of thing that, if the drug was giving you your life back, paying the price of these side effects is really a no brainer.. or at least that is the way I look at it).. There was also a pediatric trial... again, the same general results. A safe, effective way of treating IBD in young and old. The only change in the pediatric study was that, in the case of children, dosages were based on body size.. by weight. I don't have the numbers... or the formula.. but I'm sure someone on here has the info.

Look, this isn't my 'mission from God' as it were... but my honest to goodness opinion. If I didn't have this disease, and didn't have all these years of success and experience with it... but were just looking at high success rate, high safety factor, low risk factor, I would independantly advance the theory that LDN should be the absolute 1st drug to look into. I don't own the company (nor any part of it, dammit) and they don't pay me royalties for talking like this. In fact, just the opposite. I spend $86 CDN every 3 months. (Hmmmm, you think with all the good word I spread, I'd at least be entitled to a discount). Kidding aside, I can't think of a safer, saner choice to fight off IBD, OK?

I'm really excited to see what happens with Xeljanz. I think it seems really promising for IBD. And it's a pill, so that's an added benefit. Pills are easier to take than injections or infusions.

why are pediatric gi doctors so opposed
to even talking about LDN if its so fantastic?
Its like bringing up a bad topic at the appts.
Ours even kinda does an eye roll. Its not
even discussed. I've asked a few times and
its like they are "REALLY??...Move on..."

Yeah, that's confused me too.

I know there's lots said about doctor kickbacks, perks, etc. but I really have a hard time believing that doctors would ignore a safe treatment simply due to perks and pharma company influence.

On the other hand, the immunosuppressants, biologics, 5-asa (whether they work or not) are well known, well studied, etc. For a doctor to prescribe LDN, he/she is going out on a limb... if the patient worsens, it's their reputation... ie why would you give your patient LDN when you have all those proven treatments at your disposal? Is that a risk the doctor wants/needs to take?

It would be interesting to know how long it took for GIs to commonly use EEN as a treatment... we know, even with it's track record and studies, many GIs still don't believe it works.

So what baffles me is Jack's GI who brought up LDN as an option, when we talked about EEN says he wasn't sure that it worked at least from the studies he read. I don't think he routinely prescribes LDN as from what he has said Jack was the only one doing really well on it from the handful of his patients that were on it, but based on Jack if someone wanted to try it he would but I don't think he brings it up anymore.

If I remember correctly, Jack was doing well but, given Jack's age, due to drug risks in young boys, his GI suggested trying LDN??

There's always one rebel in the class! I imagine he'd read good things and thought Jack was stable enough to try. He could justify his decision by saying his patient was stable and the risks of 'undertreated' crohns were less severe than the risks of adding stronger meds given Jack's circumstances (age, sex, disease activity).

IDK???

I think you hit the nail on the head Tess, he was doing well (not 100%) and we couldn't use MTX which is apparently what he generally does for teen boys that are doing well and don't need biologics. In his words he likes to keep the biologics in his back pocket so to speak.
Looks like we may be moving towards biologics for the hubby though, His liver levels are way out of wack so Imuran may not be an option for us anymore - goes for another blood test in 2 weeks so we'll see. His GI won't even look at LDN but I think I may go to his next appt. and bring all Jack's stuff and see what we can do. I'll push for it harder then the hubby.

I'm not sure about the LDN issue. I know our GI has used rifaximin, flagyl, cipro, vanco, and low dose long term pred based either on one or a few very small studies or purely on clinical experience to treat my daughter. Rifaximin for IBD is off label and there's only one study (or was at the time) backing it. Also, drs will use mtx for UC even though again there's really only one small study with limited efficacy and the Cochraine Library review concludes that it's not effective at all. I don't personally believe that what our kids are rxed is based solely on good, hard science unfortunately.
Our GI dismissed it. We got it through an integrative dr. We've tried it for extended periods twice. Didn't work but then nothing much has. I still don't see why it shouldn't be tried if other unproven or ineffective treatments (including asas for CD) are.

Why hasn't LDN been widely adopted and accepted? Good question. I have some "gut" hunches... pet theories. First off.. there have been only 3 studies.. 2 on adults, and 1 pediatric. The 1st study was criticized for being performed on a very small group (less than 30 patients.. don't hold me to it.. I 'think' it was 27) and not being a double blind study. (I don't know if this latter complaint is fact based or not, it may be just some mud slinging).. The 2nd study upheld the findings of the 1st, and I never heard of any criticisms on sample size or other irregularities. Then, the pediatric study, with pretty much the same conclusion... safe and effective. So, the 'number' of studies to some Dr's poses a problem. Mind you, as others have noted, some meds Dr's do seem to push have little or poor scientific credendials.. either few studies or lack luster results that are also combined with some pretty severe potential side effects. Makes you wonder.
I know some doctors are too busy to do more than they currently are handling, so when a patient shows up with studies, info and suggestions.. it pretty much just gets filed away... LDN lacks an organized pharmaceutical company with deep pockets and sales reps to push it, intro it to doctors, wine N dine them, hold their hands, re-assure them, etc., etc.. Have any idea as to what lengths, what expense, these companies go to to sell their products? Years ago, when I was a young, handsome devil... I dated a lovely lady doctor. She was invited to a dinner hosted by a pharma company. I was her date. It was strictly black tie, evening gown. The company rented the Citadel (goggle the Halifax Citadel... a national historic fortress... and available for private parties if the price is right..). They served the group of local doctors who attended a 7 course meal, each food course was preceeded and followed by 2 wine courses... and these wines don't come in cardboard cartons. All imported, all expensive, and the food and beverage was free... all you had to do was sit through a 20 minute presentation on this companys brand new treatment for migraines. So, tally up in your heads what food, wine, and the setting... a fortress.. for 200 people would cost? And, although Halifax is a nice city, it is rather on the small side... try to put a dollar figure on what a larger city might rate. And, this was 1 dinner... 1 drug.. how many times before or since has that repeated???

Sure, some docs put their patients first... like mine did. Others are overly cautious. Is it their patients who their primary focus is on???? Hmmm, patient is getting worse, drugs currently being used are not working, or not working well, and they present side effects of potentially... catastrophic.. proportions. Should the doctor try this .. LDN???? Hmmm, no big company, no sales rep offering him/her dinners, freebies, support, advice. If it doesn't work.. who is the doctor going to blame??? It is off label prescribing. Some doctors fear their peers will ostracize them for going with an unorthodox drug like LDN.

I 'understand' the docs who are too busy, or just too lazy, to do the real research on it. I understand the docs who fear losing their source of referrals from conservative doctors. I understand (it may not be quite as bad here in Canada yet, but doctors here REALLY fear lawsuits.. I know their US counterparts are suit paranoid) AND if a doctor tried something.. unorthodox, experimental, on my kids.. and it didn't work.. a lawsuit would be the least of their worries... So, there are all kinds of legitimate reasons that LDN is still not front and center. It's annoying, frustrating, I 'hate' the thought of folks suffering when this potential solution is out there... but I'm OK with that. Que sera, sera.

What really grinds my gears... is when doctors deliberately obfuscate, or cloud the facts on LDN. Making comments, statements, that are not based on the actual facts/studies.
I cannot hazard a guess as to what would drive a so called 'professional' to act this way.

OK, off the soapbox...

fecal transplant have been shown to cure UC and also seem to cure crohns too

been studying this for about 2 years now http://www.crohnsforum.com/showthread.php?t=52400