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Crohn's Disease Forum » Treatment » List of all Past, Current and Future Treatments for IBD


 
05-27-2016, 02:59 PM   #61
xeridea
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An update on BI-655066 (from the master list in the top post here).

Now being referred to in a more traditional name for a biologic, risankizumab, in a randomized and blinded, placebo controlled Phase IIa (dose discovery) trial showed favorable results vs. placebo with fairly good safety signals and showing effectiveness in a refractory patient population.

“This was conducted in a very refractory patient population; 94% of patients had actually received TNF-blocker therapy and had failed or were intolerant to those drugs,” Feagan said. “At week 12 what we saw in the pooled group — the 200 mg and 600 mg [groups] taken together— was [the] overall rate of remission was approximately 30% vs. 15% [with placebo], which was statistically significant. But perhaps more importantly, the high dose of the drug ... was approximately 36%, and there was a dose-response curve where the low dose was intermediate between placebo and the high dose. So, a very clear proof-of-concept, with dose-linearity of response ... about as good as you can get in a phase 2 study.”

This drug is being developed by Germany's Boehringer-Ingelheim and should now start moving into phase III trials.
05-27-2016, 03:08 PM   #62
FrozenGirl
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Thanks go the updates xeridea. Also risankizumab sounds very promising given the result within TNF failure group. It sounds like a higher dose might give an even better response, if they could get to the 40-50 percent remission rate it could be a blockbuster drug.
06-10-2016, 09:27 AM   #63
xeridea
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4D Pharma has re-started their Phase 1 trial of Thetanix for Pediatric Crohn's Disease. Thetanix is based on bacteroides thetaiotaomicron, a major symbiont of the adult human gut. It helps with digestion of many complex starches for which we don't have the enzymes, helps in the formation of the mucus layer and promotes the generation of new blood vessels in the gut.
06-10-2016, 10:46 AM   #64
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Hi xeridea, when you say we "don't have the enzymes" what do you mean? I am just curious - is this because of the immune disposition of Crohn's patients?
07-15-2016, 09:54 AM   #65
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Re: Refractory Perianal Fistulas

Takeda has licensed European riights to Ti-Genix's Cx601 treatment. They will further develop and commercialize the treatment. Takeda is the Japanese company that produces Entivyo.

The Cx601 treatment is wrapping up Phase III trials in Europe and expected to be approved there in 2017.
07-30-2016, 08:24 AM   #66
xeridea
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Seres reports disappointing interim results on its SER-109 "poo;-in-a-pill" drug for recurrent CDI. There was no statistically significant difference between the drug and placebo. They're trying to figure out why this doesn't align with earlier, much more promising results.

http://finance.yahoo.com/news/seres-...110000711.html
08-22-2016, 10:06 AM   #67
xeridea
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4D Pharma announced that they have initiated Phase 1 trial of Thetanix for Pediatric Crohn's Disease. Phase 1 trials are for figuring out the proper/safe dosing levels of a drug.

Here is an excerpt from the top-post for Thetanix, where it was referred to by its pre-clinical development name LBP-001:

Thetanix, comprised of Bacteroides thetaiotaomicron, an obligate anaerobe, is a major endosymbiont of the human gut. Bacteroides thetaiotaomicron is a major component of the adult intestine and has been used as a useful model for the study of human-bacterial symbiosis. Its metabolic function for humans is to degrade plant polysacharides, a very essential capability for the human gut. Additionally, it is very important during the postnatal transition between mother's milk and a diet heavily consisting of plant starches. It has been found to stimulate angiogenesis (growth of new blood vessels from pre-existing vessels) within the gut, due to a microbial signal via bacterial sensing Paneth cells. B. thetaiotaomicron benefits its host by providing sufficient absorptive ability for nutrients the microbe helps process. Another postnatal developmental process within the gut mediated by Bacteroides thetaiotaomicron is the formation of the intestinal mucosal barrier, which helps protect the host against pathogenic invasion via the regulation of the expression of species-specific protein antibiotics. The environment sensing regulatory apparatus present in B. thetaiotaomicron allows for adaptive food seeking, which stabilizes food webs, and subsequently leads to the longevity of communities.
09-12-2016, 08:49 AM   #68
xeridea
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Celgene today announced interim topline results from their CD001 GED-0301 (mongersen) oral antisense therapy.

This preliminary evaluation had a proportion of patients showing 25% or more endoscopic improvement, suggesting that mucosal healing is underway and that the drug is correctly targeting the underlying cause of Crohn's.

This is an assessment at the first 12 weeks of the Phase 1b study, a period where patients have been taking daily doses of the drug. The next leg, lasting 52 weeks, will continue to monitor these patients and includes further endoscopic evaluation. Final study results are expected in 2017. They are also ramping up for the start of the Phase II study.

More specific data on this preliminary leg will be presented later this year at a scientific meeting.
09-19-2016, 05:37 PM   #69
Crohn2357
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http://ibdnewstoday.com/2016/09/16/c...-disease-study

“These data support the notion that GED-0301, a potential first-in-class oral antisense therapy, may target an underlying cause of Crohn’s disease, rather than simply improving symptoms.

GED-0301 takes an unusual approach to treating Crohn’s, using antisense technology to target a key intracellular signaling protein thought to be involved in intestinal inflammation and the pathogenesis of the disease. It is orally administered and designed to act locally."

How? Forgive my ignorance, but I can't see a fundamental difference of action between this and humira.
09-27-2016, 09:01 AM   #70
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Aerpio has begun Phase 1a safety and tolerability study of AKB-4924. This is a small molecule, HIF-1α (hypoxia inducible factor 1 alpha) stabilizing agent. HIF-1α is critical for the regulation of innate immune responses and maintenance of epithelial barrier function, particularly in the gut. AKB-4924 is being developed as a once-daily, orally administered therapy for IBD.

In multiple in vivo preclinical models of IBD, AKB-4924 has been shown to markedly reduce disease activity, with decreased levels of inflammation and preservation of mucosal integrity.

HIF is a master regulator in the control of gene expression in response to changes in tissue oxygen levels. Though HIF is commonly associated with changes in vascular growth, it is also critical for the regulation of innate immune responses and maintenance of epithelial barrier, particularly in the gut and skin.
10-07-2016, 08:45 AM   #71
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I gleaned this news from the anti-MAP therapy RHB-104 from the 'MAP Vaccine Ready for Human Trials' thread, posted by Scared1. Big news for folks tracking treatments of Crohn's.

On the contrary - very good news if you tuned into their webcast (I did). By increasing their length of the trial - they are able to show greater efficiency because they have a larger sample size, and they are introducing an early stop process for very success results as an option. The interim results are very good and a new paper was published:

"A single capsule formulation of RHB-104 demonstrates higher anti-microbial growth potency for effective treatment of Crohn’s disease associated with Mycobacterium avium subspecies paratuberculosis"
Additional notes:
I added the link to the above paper. See also RedHill Biopharma's Crohn's page and their 6 October 2016 announcement.

Antimicrobial (anti-MAP) therapy is different from the vaccine, but both developing therapies target MAP (mycobacterium avium paratuburculosis). There is much evidence supporting MAP as a cause of Crohn's, although this remains controversial and is ignored by most gastroenterologists and CCFA. If you are not familiar with this topic, good starting places are Phil Nicholson's Crohn's Controversy video, and the Core Literature packet downloadable from Dr. John Hermon-Taylor's group.
10-17-2016, 10:00 AM   #72
xeridea
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Celgene released some additional positive data from their Phase 1b trial of GED-0301 (mongersen). Of note is the endoscopic improvements that were observed.

From this source:

Clinical improvement was seen by week 2, and clinical response (CDAI decrease ≥100) and remission (CDAI <150) rates were highest in the 12-week treatment group at 67 and 48 percent respectively, at week 12. The mean CDAI reduction from baseline at week 12 in the 12-week treatment group was 133 points. Of the patients with evaluable endoscopies at week 12 (n=52), 37 percent had an endoscopic response (≥25 percent reduction in SES-CD score from baseline), with no meaningful difference across treatment groups. In addition, of those patients with greater endoscopic disease activity at baseline (SES-CD score of >12; n=16), 63 percent exhibited a reduction ≥25 percent in SES-CD score and 31 percent had a reduction of ≥50 percent.
11-22-2016, 02:38 PM   #73
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I will be probably involved in the GED-03-01 ( Mongersen) in a few week...
01-06-2017, 06:22 PM   #74
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Enterome is gaining more traction on the AIEC (Adherent Invasive E. Coli) front by securing an exclusive worldwide license of Vertex Pharmaceuticals small molecule FimH antagonists. FimH is a cell surface adhesion protein that allows the pathogenic E. Coli to stick to the gut wall and penetrate it, which leads to inflammation.

They will embark on their first clinical trial of one of these drugs, EB8108, later this year.

Looks like the AIEC race is on...
...and it was announced yesterday the kickoff of their Phase 1 trial.
05-24-2017, 12:26 AM   #75
DB in PVE
 
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I would like to see dietary treatment included in this list because it's very effective and not all treatment has to be pharmaceutical. I have a link to a short video from Dr. Micheal Greger summarizing the research on this but am not able to post it here because I'm a fairly new member. But the study showed that the group assigned to a vegetarian diet achieved a higher and more sustained remission rate than any study ever documented. That's pretty powerful. The video can be found on the Nutrition Facts website.
08-13-2017, 10:41 AM   #76
jlvk
 
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I don't know if this is silly question, but does anyone go without Humiera or TNF blockers and just treat during "flare ups" ? Im on prednisone right now for the inflammation they found, as well as antibiotics for an abscess that was caused by the disease. I'm very newly diagnosed and don't know whole lot about the condition but I figured there may be different severeties and I'm wondering if it is possible to go without the injections. Also trying to weigh the risk of taking/ not taking the injections (if it is at all possible).
08-13-2017, 11:02 AM   #77
Guerrero
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Not everyone are on biologics it depends on your condition. A good GI should assess what's the best therapy for you.
Biologics have to be taken for long term period without quitting it to avoid building antibodies, while steroid for short term period to avoid many side effects.
Dont hesitate to ask question should you need further info
08-13-2017, 11:19 AM   #78
jlvk
 
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This is extremely helpful! Thank you, I really want to make sure it's necessary before I committed into it.. this makes me very hopeful.
08-13-2017, 01:22 PM   #79
DB in PVE
 
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It may be helpful to review this outstanding resource for understanding the published medical studies regarding Crohn's disease and diet (ie, clinical nutrition). I have learned so much here. I have healed my own GI issues by making changes to a whole food plant-based diet. Most physicians have not been trained in nutrition and don't have time to keep up with all the medical journals so this is an important resource and they synthesize it down to easy to understand videos.

I am not yet a frequent-enough poster to be allowed to post a direct link, sorry.
Just go to the nutritionfacts dot org website and search on the word Crohn and it will all come up.

DB
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