RedHill Readying Phase III Trials In Crohn's for Triple Antibiotic Pill

[nogutsnoglory]

"RedHill is preparing to begin a potential groundbreaking Phase III study in the current quarter in North America and Israel (the MAP U.S. Study) of Crohn's disease, using a novel patent-protected formulation that combines three antibiotic ingredients in a single capsule, and is planning and preparing a parallel Phase III study in Europe (the MAP Europe Study)."

http://seekingalpha.com/article/1645962

 

[kiny]

It's clarithromycin, clofazimine and rifabutin.

Have nothing to say but I think that if MAP is present you would need an antibiotic that is specific and is effective against non-dividing cells or you'll be chained to years of antibiotics treatment because of the slow division of MAP, which will result in resistance and the antibiotics will be ineffective.

An issue with rifabutin is also that it's needed for other mycobacteria, like TB.


I do hope when people do trials with antibiotics that GI recognise that it's highly unlikely that crohn's disease is a single disease. You can't ignore the benefit of antibiotics for crohn's disease by ignoring that if there is an intracellular pathogen involved it will unlikely be 1 type, and patients will harbour many different strain, just like in any other infectious disease.

 

[rollinstone]

to eradicate it yes, but at the same time this potentially offers relief to many who don't respond to traditional CD meds.

 

[kiny]

right, I agree

 

[rollinstone]

there is a professor who is developing a vaccine against MAP, I don't know how he intends for it to work but I don't think they're overlooking the fact that map is extremely slow dividing, but the use of the multiple antibiotics is what stops the MAP from developing resistance, if it was to develop a resistance to one, the other antibiotics kill that resistance

 

[sir.clausin]

Ok so this is Thomas Borodys "famous" antibiotics for MAP. Hmm..but what is the benefit of this versus taking clarithromycin, clofazimine and rifabutin at the same time?

I wonder what ever happened to this http://www.crohns.org/treatment/vaccine.htm
it just Went dead....

Do we have a 100% method on diagnosing/finding MAP in tissue/blod now? If I go to my GI and say that I want them to look for it would it be possiable or do you need a fancy expensive Equipment? It would only be for my own curiosity.

 

[rollinstone]

yeah its a bit weird, I asked my GI about MAP he said it causes something like CD but not CD, I think theres a lot of discrepancy about it, its found in a lot of patients, is it a causative or is it making it worse, dr broody has had success with it, and then there have been people who haven't responded, I think they can detect MAP better than in the past but I don't know if its 100% full proof.

 

[sir.clausin]

Kiny, what´s your take on this? Do I ask for dna sequencing on inflamed tissue?

 

[kiny]

Ok so this is Thomas Borodys "famous" antibiotics for MAP. Hmm..but what is the benefit of this versus taking clarithromycin, clofazimine and rifabutin at the same time?

Nothing. But doctors will not give patients medication unless it's in a standardised formulation.

Why do doctors all use 500 / 1000 mg ciprofloxacin, even though patient weight, diseases, bacterial load, all differ. Why don't they use 600mg or 300mg. Because they want a standard treatment, they want to be able to say "I gave him X like it said, not y or z, X"

So if you put those 3 antibiotics into a single form or treatment, doctors might be more willing to use it.

Of course it could also make them more reluctant, especially because it has rifabutin in it, since rifabutin is used extensively for TB too. What do you do with a patient on long-term rifabutin once they get TB.


There's the fact you can sell it too of course. Which I'm not getting into really, I'm not interested in that, nor do I know how that works.

 

[kiny]

Kiny, what´s your take on this? Do I ask for dna sequencing on inflamed tissue?

I don't know, I can't say. Yes you can ask for IS900 DNA testing on whole blood, I did, it was negative.

But what do I know extra with this, nothing. It doesn't prove or disprove I have MAP, maybe the test wasn't good, maybe it doesn't show up in blood, maybe I don't have it, maybe maybe maybe.....I am none the wiser.

As long as tests are so unreliable there's not much benefit.


On the other hand, a positive test does tell you something, it tells you you harbour MAP. A negative test just tells you nothing, since you can't draw any conclusions from it.

 

[kiny]

Btw, afaik, in that study borody did, in which he showed improvement after tripple antibiotics, he did not test those people for MAP afaik.

Those antibiotics are effective against a whole host of intracellular organisms.

You can not give someone those antibiotics and say "this shows MAP is causative" or "they had MAP"...(not saying he did, I'm just saying). It tells you the antibiotics seemed to work...why....no idea....

 

[kiny]

Here's an IS900 test on patients. IS900 PCR is specific for MAP DNA.

If you want you can ask this test, on tissue or blood. Blood can very unreliable though.

Do not expect all GI to be cooperative though. Some GI are very "ivory tower / status quo" for some reason.

 

[kiny]

Do we have a 100% method on diagnosing/finding MAP in tissue/blod now?

no, there isn't even a standardised test

it's also not like with TB where there is a governing body, the WHO will come out and say if a certain TB test is not accurate, they did so not too long ago

there is no governing body overviewing MAP testing, especially not in humans

If I go to my GI and say that I want them to look for it would it be possiable

depends entirely on the GI

do you need a fancy expensive Equipment? It would only be for my own curiosity

no, you need a lab with experience detecting MAP

 

[GypsyRay]

In regards to MAP testing for humans... I wonder if you all have read or seen this study:

"Molecular identification of Mycobacterium avium subspecies paratuberculosis in oral biopsies of Crohn’s disease patients"

(Google it... I'm too much of a newbie to be allowed to run around posting links.)

I think I recall something about a study for fecal testing for MAP too.

I recently asked my GI to test me for MAP and she said MAP was a natural occurring mycobacterium in the human gut.

To which I asked, "A mycobacterium related to TB and leprosy is occurring naturally in me?"

She nodded yes.

I'm not sure how this makes me feel.