RedHill Biopharma Presents Crohn’s Disease Therapeutics Program at International Research Symposium

Someone posted this on the Anti-MAP board, thought it might be worth posting here, so I just cut and pasted it.

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"Agree. Great symposium. I would encourage folks to look for the presentations online. The symposium's web claims the presentations will be coming soon. thecrohnsinfection.org/symposium-information/

I found Dr. Amy Hermon-Taylor's presentations (yes, both of them) to be great & encouraging news. They were all really good, though I felt that Aitken's material was mostly of use to other scientists interested in the specific morphology of different forms of MAP (ie. not much actionable stuff for the layperson who wants to deal with his/her Crohn's). But great stuff from Mr. McClean, and Drs. Hermon-Taylor, Chamberlain, Collins, and a late addition to the agenda, David Rubin (Prof of Medicine, Chief, Section of Gastroenterology, Hepatology and Nutrition, University of Chicago). There were a few A/V problems which slowed things down a bit, so be forewarned if you look for the presentations online... They'll take some time to go through.

I tracked down one of the interesting references on genetics susceptibility to IBDs and mycobacterial infection. One of the presenters described this as a "pivitol paper." Host–microbe interactions have shaped the genetic architecture of inflammatory bowel disease www.nature.com/nature/journal/v491/n7422/full/nature11582.html

Opinions / take-home messages from this interested layperson:

1. If you've got debilitating Crohn's, get on anti-MAP therapy using some version of Dr. Borody's 3-drug cocktail. Find a Doctor who will be willing to prescribe such a regimen. Consider ramping up the dosage gradually, rather than hitting it hard right from the get-go. Fewer side effects (flu-like symptoms).

2. If you're not quite at the debilitating Crohn's stage, might want to do option 1 anyway. Or, consider the ongoing clinical trial that Red Hill is conducting. (see anti-map.org/index.php/getting-started/g...tor?showall=&start=4 for more on the clinical trial).

3. There is real hope for a vaccine that will both prevent and "cure" MAP-caused Crohn's. There is also hope for other therapies that will enhance the body's immune system to fight off MAP.

4. This symposium should have been required for gastroenterologists. I was disappointed in the low turnout of local doctors, except for Dr. David Rubin.

ibdnewstoday.com/2015/08/28/redhill-biopharma-issued-notice-of-allowance-for-new-israeli-patent-covering-rhb-104/

RedHill Biopharma Issued Notice of Allowance for New Israeli Patent Covering RHB-104

"Israel-based biopharmaceutical company RedHill Biopharma Ltd., announced it has been issued a Notice of Allowance by the Israeli Patent Office for a new patent (No. 207420 – “Methods and Compositions for Treating Inflammatory Bowel Disease”) which covers RHB-104, a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation, with potent intracellular, anti-mycobacterial and anti-inflammatory properties. The company expects the patent, once granted, to be valid until 2029.

This patent allowance in Israel expands the global reach of RedHill’s intellectual property for RHB-104, adding to existing US patents and pending applications in other territories.

RHB-104 is based on increasing evidence supporting the hypothesis that Crohn’s disease is caused by the Mycobacterium avium subspecies paratuberculosis (MAP) infection in susceptible patients. At present, RHB-104 is undergoing a multinational Phase III trial (MAP US) on patients with Crohn’s disease. A second Phase III study is set to launch in European countries and will run parallel to the ongoing MAP US study. Preliminary results of the ongoing MAP US study, which is a randomized, double-blind, placebo-controlled trial, are expected within the second half of 2016, once half of the targeting 270 patients are enrolled and have completed 26 weeks of treatment with RHB-104.

The drug is also undergoing tests as a potential treatment for relapsing-remitting multiple sclerosis (RRMS). The company recently enrolled the last patient in this open label Phase IIa, proof-of-concept clinical study that aims to evaluate RHB-104 as an adjunct therapy to interferon beta-1a in RRMS. Preliminary results are expected towards the end of 2015, or within the first quarter of 2016.

To learn more about the ongoing MAP US Phase III study, titled, “Efficacy and Safety of Anti-MAP Therapy in Adult Crohn’s Disease (MAPUS)” visit www.ClinicalTrials.gov and type in identifier number NCT01951326."