Direct link to their announcement: https://www.redhillbio.com/news/new...dHills-RHB-104-in-Crohns-Disease/default.aspx
News from RDHL - RHB 104 update
- Thread starter Veske
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Good news, thanks for sharing
I thought you disregarded the MAP stuff as a waste of time?
Might be related to their financial situation. The stock went through some reverse-splits as well during the after-covid crash. They did rake in some cash now with Talicia and Opaginib seems to be promising as well.
Why?
If it turns out that Crohn is bacterial infection then only antibiotics will be taken into account
My disease happened when I was trying to lose on weight.
Only thing that I ate were shakes made of banana and milk (which is said that may cause MAP infection)
Stomach ulcers are caused by helicobacter and intestine ulcers may be caused by this bacteria. Who knows?
I hope it is truth and keep fingers crossed
If it turns out that Crohn is bacterial infection then only antibiotics will be taken into account
My disease happened when I was trying to lose on weight.
Only thing that I ate were shakes made of banana and milk (which is said that may cause MAP infection)
Stomach ulcers are caused by helicobacter and intestine ulcers may be caused by this bacteria. Who knows?
I hope it is truth and keep fingers crossed
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I support the hypothesis of a Mycobacterial basis to the Crohn disease. This works in my case.
But I would also like to know the following things:
1) Does the MAP mean that Crohn's is not an autoimmune, but an autoinflammatory disease?
2) Does the MAP only affect people who have a genetic predisposition?
3) How does this correlate with the fact that more people in northern countries suffer from Crohn's disease than in the south? Or the increase in Crohn's patients with the emergence of Covid-19?
1) MAP according to researches is an autoinflammatory disease
2) yes, MAP only affect people who have a genetic predisposition
3) in south high dose od vit D can inhibit inflammation /vit D should be taken in dose of 10000IU
4) Covid as virus could triggered disease which was calm by that time- I also suffer from 2021 after Covid disease and vaccine injection
2) yes, MAP only affect people who have a genetic predisposition
3) in south high dose od vit D can inhibit inflammation /vit D should be taken in dose of 10000IU
4) Covid as virus could triggered disease which was calm by that time- I also suffer from 2021 after Covid disease and vaccine injection
kiny
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Several Mycobacteria have caused unimaginable human and animal suffering, that alone makes research into MAP worth looking into. MAP causes paratuberculosis in ruminants which causes extensive ileal inflammation in those animals, they discharge MAP and their feces will eventually infect the whole herd, it can easily travel to other farms through aerosol and waterways, it's everywhere. If MAP causes disease in humans is not as easy to answer, showing some people with crohn's harbour MAP is not sufficient, you need to prove the bacteria acts as a pathogen in humans, and not just a transient guest.
News from redhillbio
https://www.redhillbio.com/news/new...Positive-RHB-104-Phase-3-Results/default.aspx
https://www.redhillbio.com/news/new...Positive-RHB-104-Phase-3-Results/default.aspx
At this stage nobody knows it but at least few years, I think?
In terms of clinical trials, they are going backwards. Apparently, their Phase 3 data, though statistically "positive," were not strong enough to submit for FDA approval. So they have gone back to Phase 2 to focus their clinical trial populations more narrowly: they will enroll only Crohn's patients who also have proven MAP infections. And they will also be measuring stronger trial endpoints (outcomes) of mucosal healing measured by colonoscopy and advanced imaging evaluations rather than the weak and vague outcome of "improvement" used in the prior Phase 3 study.
So they have a long way to go. Assuming this new Phase 2 trial works out, they will likely then need to repeat the Phase 3 trial to incorporate what they learned in the new Phase 2. And, assuming the new Phase 3 is successful too, they will need to prepare and submit their FDA submission. Depending on the strength of the data the FDA, after a review taking anywhere from 6 months to several years, could accept or reject the drug or perhaps demand further trials.
One thing to note, assuming this all works out, the use of the drug will be limited by the FDA to only Crohn's patients with proven MAP infections, since that is what will be enrolled in the new Phase 3 trial. That might reduce the eligible population by about half or more, depending on which study you believe about the prevalence of MAP infection in Crohn's patients.
