Anti-MAP antibiotics against CD - Redhill study results

[Deleted member 431298]

This thread is dedicated to discussions regarding the top-line results of the RHB-104 antibiotic pill conducted by Redhill Biopharma.
The results are due in july 2018, and the research outcome will cast more light on whether an infection with Mycobacterium Avium Ssp. Paratuberculosis (MAP) can cause / sustain Crohns disease in humans.
Selby et.al made a similar study back in 2003 but with a slightly different combination of antibiotics. The conclusion was initially that no effect was found, but later the conclusion was put into question, and a re-analysis concludes that the antibiotics did help induce remission.

The ambiguity of that study is what makes this new study by Redhill so interesting. If the researchers make a rigorous and credible analysis we will finally get an answer to the question: Can the treatment of a MAP infection lead to remission of Crohns Disease?

Results are in soon and will be posted here when they arrive so we can discuss their implications.

 

[Deleted member 431298]

Here is a link to an interview with a representative of Redhill on Youtube:https://youtu.be/2o3bdL3RUlc

Of course he talks about the study as being potentially groundbreaking

It will be interesting to see if the data supports that claim. I am especially curious to see the expirienced side effects. Two forum users have tried a regimen similar to rhb-104 and have experienced severe side effects.. others report no side effects. As this is all anecdotal it is not something a GI will use. Hopefully this study will change that and provide clinical evidence of the side effects.

 

[Deleted member 431298]

On july 2nd Redhill announced release of the study results “within the coming weeks”. I think they will be put up on their press release page: https://ir.redhillbio.com/press-releases

 

[irishgal]

My guess is mid-August. Excited to see what they say!

 

[Gabriel89]

It is published on their site

 

[irishgal]

Positive RedHill results!

https://globenewswire.com/news-rele...-III-Study-of-RHB-104-in-Crohn-s-Disease.html

 

[eleanor_rigby]

The numbers of people in remission seem low. Only 18% achieved continuous remission from weeks 16-52. I’m pleased their findings were significant but I guess I was hoping for higher numbers achieving and sustaining remission, given that so many hope this avenue of treatment could lead to a possible cure??!
I really would be interested to know actual colonoscopy findings. I know studies get approved based on CDAI alone but I hope one day there will be a shift in that.
Still I am all for this drug being added to our treatment options, the more options the better.

 

[irishgal]

I really would be interested to know actual colonoscopy findings. I know studies get approved based on CDAI alone but I hope one day there will be a shift in that.

The secondary results like MAP levels and endoscopic mucosal healing data are coming. I think they said 1-2 months.

 

[eleanor_rigby]

https://www.fiercebiotech.com/biotech/redhill-s-rhb-104-hits-primary-endpoint-crohn-s-phase-3

 

[irishgal]

These stock and trading reports don't necessarily analyze the medical impact the same way the healthcare community would. Did you comment have something to do with endoscopic data? I was on the Webinar, and they mentioned mucosal data still to come.

 

[Crohn2357]

..

 

[Gabriel89]

Compared to Humira i dont see the superiority of this antibiotics treatment as it was stated in some websites promoting AMAT.

Regardless of the numbers its good to have any additional knowledge in this subject.
And yes let the doctors have more tools if it helps at least some.

 

[Scipio]

It's encouraging that the trial showed a clinical benefit, but these results are kind of modest and perhaps not very durable over the long run. They may however be sufficient to gain FDA approval once the follow-up trials are completed and the NDA filed.

Overall, I would say it will be good for docs to have this treatment as one more tool to help manage this disease, but this is far from the Cure! for Crohn's that MAP partisans have been touting for so long.

 

[Deleted member 431298]

Rednill recently went out a statement elaborating the results:
RedHill Elaborates on its Announced Positive Top-Line Results from Phase III Study of RHB-104 in Crohn’s Disease
It does seem like the remission rates are comparable with the biologics, which is good news I think. It tells ud that Redhill will most likely press forward to get a share of the huge market value those drugs represent.