REDHILL BIOPHARM - News -> RHB-104 - Possible Breakthrough Treatment for Crohn's Disease

I get so excited when I read about this possible treatment, RHB-104, for Crohn's!  I've been watching this drug for over a year now.  This is a  treatment that if approved by the FDA, I will be jumping on it as soon as it becomes available.  No doubt!  This is the kind of treatment we need.  Everything else just treats symptoms.
So, why is this so exciting?  If you read current research about what causes Crohn's disease, you will see that researchers are leaning away from considering Crohn's disease an autoimmune condition.  They have found that there is an underlying cause for the immune response to activate.  Crohn's is said to be caused by a combo of 3 factors - Immune system abnormalities, environmental influences and bacteria.  I just wiki'd Crohn's disease and this is what is said about what is believed to be the cause - "Crohn's disease is caused by interactions between environmental, immunological and bacterial factors in genetically susceptible individuals.[4][5][6] This results in a chronic inflammatory disorder, in which the body's immune system attacks the gastrointestinal tract possibly directed at microbial antigens.[5][7] While Crohn's is an immune related disease, it does not appear to be an autoimmune disease (in that the immune system is not being triggered by the body itself)."
What this means is that people that have Crohn's disease do not have the immune system capabilities to destroy a form of bacteria that have been introduced into the body at some point in time.  As research has indicated, a large number of people with Crohn's disease happen to have the MAP bacteria in their body somewhere.  The exact location of the bacteria is not known at this time.  Who cares where it is, as long as a treatment is available that will destroy it is my opinion.
See why this makes me super hopeful?  If Crohn's is caused by this MAP bacteria & if this new combination antibiotic eradicates the MAP bacteria from people with Crohn's disease, this could be the answer to the Crohn's disease epidemic!  Can someone say CURE :)
Wouldn't that be glorious?  

Clinical trial for a new antibiotic therapy for Crohn’s treatment started:

Crohn’s disease is an inflammatory bowel disease which may affect gastrointestinal tract from mouth to anus, and has a wide variety of symptoms. Mycobacterium avium subspecies paratuberculosis (MAP) is believed to be associated with Cronh’s disease. Professor Dr. Saleh Naser, UFC College of Medicine, believes that MAP is the cause of the disease. He said, "Crohn's disease affects more than 750,000 Americans, yet traditional treatments only address the symptoms of inflammation and not the cause." He further added, "I have seen case studies where patients' lives have been restored following treatment, which removes MAP. I have high hopes that this clinical trial may lead to finding a cure." Dr. Saleh Naser will soon conduct clinical trials on a new antibiotic therapy acquired by RedHill Biopharma for curing the disease. 240 participants will be recruited for this double blind clinical trial.

http://health-beauty-2468.blogspot.com/2013/09/clinical-trial-for-new-antibiotic.html



RedHill Biopharma to initiate phase III trial of RHB 104 in Crohn's disease patients

UCF College of Medicine professor Dr. Saleh Naser soon will participate in a clinical trial to test whether a new antibiotic therapy acquired by RedHill Biopharma can be used to treat Crohn's disease patients.

The FDA-approved phase III trial is expected to commence within weeks by RedHill Biopharma, which licensed Naser's DNA technology for detecting Mycobacterium aviumsubspecies paratuberculosis, known as MAP. It is believed to be associated with Crohn's disease. RedHill Biopharma developed the anti-MAP antibiotic regimen known as RHB 104. Crohn's disease is a chronic inflammatory disease of the gastrointestinal tract characterized by cramping and diarrhea.

Naser developed and patented a way to detect MAP from milk, blood and tissue clinical samples. The bacterium is known to cause inflammation in the intestines of cows. It is also linked to Crohn's disease, although its role has been debated for more than a century. Naser believes MAP is an underlying cause of the disease.

"Crohn's disease affects more than 750,000 Americans, yet traditional treatments only address the symptoms of inflammation and not the cause," Naser said. "I have seen case studies where patients' lives have been restored following treatment, which removes MAP. I have high hopes that this clinical trial may lead to finding a cure."

RedHill will be enrolling 240 subjects from the United States, Canada and Israel in this double blind clinical trial in which blood and intestinal biopsy specimens from Crohn's patients will be tested for MAP before, during and following the one-year treatment with the antibiotic RHB 104.

"Since we acquired the license to Dr. Saleh Naser's MAP detection technique in 2011, we have had an excellent collaboration with UCF," said RedHill's CEO Dror Ben-Asher. "The UCF team of researchers- is at the forefront of global academic research on MAP and its detection."

Naser is looking forward to the trial and hopes this will end the academic debate regarding MAP and Crohn's disease.

"I am ecstatic to be part of a team, which will help determine whether or not MAP is associated with Crohn's disease; certainly a final answer to a one hundred-year old controversy," Naser said.

Source: University of Central Florida

http://www.news-medical.net/news/20130918/RedHill-Biopharma-to-initiate-phase-III-trial-of-RHB-104-in-Crohns-disease-patients.aspx

RedHill Readying Phase III Trials In Crohn's

With a PDUFA target date of Feb. 3, 2014 for its migraine drug, RHB-103, and NDA filing planned for the first quarter of 2014 for the anti-emetic drug, RHB-102, RedHill Biopharma (RDHL) is now focusing its efforts on its flagship programs: RHB-104 for Crohn's disease and RHB-105 for Helicobacter pylori (H. pylori).

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).

"Following the discovery of the link between H. pylori bacterium and peptic ulcers, there is a growing body of evidence supporting the proposition that Crohn's disease and other so-called autoimmune diseases, such as multiple sclerosis, are linked to infections," chief business officer Guy Goldberg says in an interview with BioTuesdays.com, referring to emerging scientific evidence that the microbiome, or the trillions of intestinal microbes, plays a major role in health and disease.

"There's a paradigm shift of viewing the body not as a single organism but as a collection of organisms, with the microbiome as the habitat within the body," he adds.

In 2005, researchers in Australia won the Nobel Prize for identifying H. pylori bacterium and the role it plays in causing peptic ulcers. Stress and lifestyle were long believed to be the primary cause of intestinal ulcers. Fellow Australian, Prof. Thomas Borody, who is now a member of RedHill's advisory board, developed the first antibiotic treatment for ulcers.

RedHill's two lead drug candidates - RHB-104, for Crohn's disease and multiple sclerosis (MS), and RHB-105, forH. pylori - were built on the success of Prof. Borody's approaches to gastrointestinal tract diseases and infections.

"RHB-104 is the biggest program in our pipeline," Mr. Goldberg says. "To the best of our knowledge, we are the only company with a Phase III combination antibiotic approach for treating Crohn's disease, even though there is a lot of academic research connecting Crohn's to a bacterial infection."

RedHill is currently advancing six clinical programs; two of which are expected to be reviewed by the FDA during 2014, and three that are entering pivotal clinical studies.

In a research report last month, Bioassociate Innovative Consulting reiterated its "buy" rating and price target of $14.91 per RedHill American Depositary Share, "given the multiple milestones approaching and the company being on-track with the clinical programs' timelines."

Crohn's is a severe inflammatory disease in the GI tract. Existing drugs, such as Remicade, treat the inflammatory symptoms of the disease by suppressing the immune system. However, they are widely considered to have a poor safety profile and limited long-term efficacy. "There clearly is a strong unmet medical need for a better alternative for Crohn's patients," Mr. Goldberg contends. The global market to treat Crohn's exceeded $3.5-billion in 2012.

(Click to enlarge)

Phase II Study Pictures in Crohn's Patients (Borody et al (2002), Digest Liver Dis 34:29-38)

He explains that RHB-104 is a novel and proprietary combination of three approved antibiotic ingredients - clarithromycin, clofazimine and rifabutin - targeting Mycobacterium Avium Paratuberculosis (MAP). Crohn's patients are believed to have seven times greater likelihood of being MAP-positive than non-Crohn's patients.

The MAP U.S. Study will enroll 240 moderately-to-severely active Crohn's patients at 50 sites in North America and Israel. The primary endpoint is the state of remission at week 26. The study will also examine safety, the maintenance of remission through week 52, efficacy outcome measures in relation to the presence of MAP infection and other secondary endpoints.

If the study is successful, RedHill may submit a new drug application to the FDA in 2015. RHB-104 previously received orphan drug status from the FDA for pediatric use. Mr. Goldberg says discussions are underway with European regulators to begin a second Phase III study with RBH-104 in Europe - the MAP Europe Study.

RedHill also is developing RHB-104 to treat patients with relapsing remitting MS. In June, the company commenced a Phase IIa proof-of-concept trial in Israel. "This is the first time that this type of antibiotic therapy will be tested on MS patients in a Phase II clinical trial," Mr. Goldberg contends.

RedHill's second lead program is RHB-105 in development to treat H. pylori bacteria, which plays an important role in gastritis, peptic ulcers and gastric cancer. Mr. Goldberg points out that H. pylori is increasingly developing resistance to treatment with clarithromycin and metronidazole, and that standard therapy fails in up to 30% to 40% of patients who continue to remain H. pylori-positive.

A Phase IIa study in 2005 by Prof. Borody in Australia demonstrated over 90% eradication of the bacteria in 130 patients who had previously failed standard therapy with clarithromycin. Approximately three millionH. pylori-infected patients are treated annually in the U.S. market, resulting in a potential market estimated at $1-billion to $1.5-billion.

Mr. Goldberg explains that RHB-105 is a novel all-in-one combination of two antibiotics - rifabutin and amoxicillin - and a proton pump inhibitor, omeprazole. RedHill plans to begin a Phase II/3 clinical trial with RHB-105 during the quarter, he says, adding that a successful study could lead to an NDA filing in 2014.

http://seekingalpha.com/article/1645962-redhill-readying-phase-iii-trials-in-crohns?source=yahoo

Could RHB-104 Be The Cure For Crohn's Disease?? Very Hopeful Article

Wouldn't that be great!?? Actually curing the Crohn's!

Be encouraged and read this article, especially if you've been struggling with symptoms and just feeling blah because it's taking a toll on you. After reading this, you'll feel hopeful and optimistic about what's to come in the future and the advances that are in the making RIGHT NOW!

Even although the RHB-104 must undergo 2 years of clinical trials (US, Canada & Europe) before the drug can even be looked at by the FDA (our wonderful friends... that's sarcasm people), 2 years is nothing and will be here before we know it. Let's hope & pray that this medicine is found to be effective during the trial stage. If this RHB-104 is found to be successful, This would shed a whole new light on the disease and impact a huge population of people that suffer & struggle with Crohn's Disease everyday.

LOL is anyone else as giddy as me right now after reading that article?

Professor patents test for possible Crohn’s disease cure

The UCF Research Foundation has licensed a promising diagnostic test for the detection of the mycobacterium avium paratuberculosis, also known as MAP, bacterium in humans to an international biopharmaceutical company that is developing a treatment for Crohn's disease.
The diagnostic technology is able to diagnose MAP infection in humans using DNA testing based on nested PCR molecular technology. MAP is present in roughly 50 percent of people who suffer from Crohn's disease and could be a leading cause of the disease.
Dr. Saleh Naser, a professor in the Burnett School of Biomedical Sciences in the College of Medicine, patented the diagnostic technology in 2009 with hopes of using it to help cure Crohn's disease patients who are positive for the MAP bacterium.
Crohn's disease is an inflammatory disorder of the gastrointestinal tract affecting about 700,000 people in the United States alone, with no cure.
"Our goal with this technology is to help speed the process of diagnosing, treating patients with the correct antibiotics and helping the patient begin remission as soon as possible," Naser said. "We want to see a change in these patients' lives."
Now that RedHill Biopharma Ltd., an emerging international biopharmaceutical company, has licensed Naser's diagnostic technology, Naser is closer to achieving his goal of diagnosing and treating Crohn's disease patients.
RedHill Biopharma Ltd. is currently developing an oral drug called RHB-104, which is intended to treat and possibly cure Crohn's patients with MAP bacterium, but without a way to detect MAP, the use of the drug has been limited. Partnered with the UCF Research Foundation, RedHill Biopharma Ltd. is able to use Naser's diagnostic test to detect MAP DNA in the patient's blood and finally allow physicians to prescribe RHB-104 to Crohn's disease patients.
"Our findings in our lab since 2000 is instrumental evidence showing that MAP is a significant part of this disease, and therefore the technology to detect such pathogens is extremely useful for diagnosis and ultimately treating this disease; and with that, our partnership with RedHill is sure to be valuable," Naser said.
Under the license agreement, in consideration for an exclusive license for all indications and medical applications, RedHill Biopharma Ltd. will pay UCF an upfront payment, as well as future net sales royalties of 7 percent to 20 percent.
Despite monetary advantages, Naser is most looking forward to putting his technology to use. RedHill Biopharma Ltd. is currently in discussion with Naser regarding the use of his technology to screen Crohn's patients for MAP infection to determine whether RHB-104 would serve as an effective treatment option in two parallel placebo-controlled, double-blind clinical trials, one in the U.S. and Canada, and one in Europe.
The trials will last two years and from there, if successful, Redhill Biopharma Ltd. will bring the data to the Food and Drug Administration for approval of RHB-104, and then Naser's technology and RHB-104 could possibly be readily accessible in local labs within five years.
If available to the public, patients will first get a blood sample taken at their doctor's office, which is then sent to a local lab where the blood's white blood cells are isolated and screened for DNA of the MAP pathogen. The information from the lab will be sent back to a doctor, who can then prescribe the patient with the either RHB-104 or an antibiotic to fit the patient's needs.
This is most hard-hitting for Naser, because he knows if these trials are successful, he could impact patients' lives.
"It is hard to establish the immense amount of phone calls and emails I receive from patients and their families who are desperate to be tested for this bacteria, because what is out there is not good enough and is not helping them beat this disease," Naser said. "For the first time, we might be talking about curing Crohn's disease and not just managing the disease; the patients know the difference."
For junior language arts and English education major Molly Taylor, that difference could change her life.
Taylor has suffered from Crohn's disease for seven years, first being diagnosed in her freshman year of high school. The diagnosis forced her to quit cheerleading as she became very sick with treatment. She dropped down to weighing 85 pounds, and soon she could not even go to school; instead, she had to take online classes for a year.
After going through invasive diagnostic procedures, trying five different treatment methods and now giving herself shots every week, Taylor is thrilled about this new discovery.
"The diagnosis process has been really hard and very invasive, but this sounds like a less invasive test. Blood samples are like nothing for Crohn's patients," Taylor said. "And to have found a cure for this would be the most amazing news for me. It is hard to face a disease daily that you know is never going to go away, especially when you first find out at 15."
For research assistant Sammer Elwasila, who has been working alongside Naser since 2006, this new technology means a new beginning for Crohn's patients like Taylor, and he is excited for the chance to make a difference in people's everyday life before it is too late.
"With this technology, we hope to accomplish a clinical test that a physician can order on the spot, and that can identify and diagnose Crohn's disease patients as quickly as possible, before the damage is done," Elwasila said.