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16
Oct

Crohns: RedHill Biopharma's RHB-104 Achieves 80% Remission in Independent Pediatric Crohn's Study

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TEL-AVIV, Israel, Oct 15, 2013 (GLOBE NEWSWIRE via COMTEX) -- -- The retrospective study, presented at the 2013 American College of Gastroenterology (ACG) Annual Scientific Meeting, demonstrated strong results with a high remission rate of 80%

 

-- RedHill's RHB-104 is a new and improved proprietary single-pill formulation of the combination of active ingredients used in the retrospective pediatric study

 

 

 

 

-- The independent, single-site, retrospective pediatric study was conducted in Australia by Prof. Thomas Borody, MD, a member of RedHill's Advisory Board, a renowned researcher in gastrointestinal diseases and the developer of RHB-104

 

-- RedHill has recently initiated a Phase III study in the U.S. with RHB-104 for the treatment of Crohn's disease in adult patients and plans to initiate a second Phase III in Europe by mid-2014

 

 

RedHill Biopharma Ltd. RDHL +2.00% (tase:RDHL) (the "Company" or "RedHill"), an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary formulations and combinations of existing drugs, reported the presentation of a poster at the ACG (American College of Gastroenterology) 2013 Annual Scientific Meeting on October 14, 2013, and the pending publication in the American Journal of Gastroenterology, of positive results from an independent, single-center, retrospective study with 10 pediatric patients suffering from Crohn's disease - an inflammatory disease of the gastrointestinal system with significant unmet medical need. The patients were treated with an earlier formulation of RedHill's RHB-104 anti-MAP (Mycobacterium avium subspecies paratuberculosis) combination therapy, using the same active ingredients in doses adjusted for pediatric usage.

 

 

The study was conducted by Professor Thomas Borody at the Centre for Digestive Diseases in Sydney, Australia, and was aimed at evaluating the safety and efficacy of the anti-MAP combination therapy for the treatment of Crohn's disease in pediatric patients.

 

The result of the retrospective Australian study demonstrated a clinical remission rate of 80% in 10 pediatric Crohn's disease patients, aged 8 to 17 (median:14.3), treated for six to 117 months (9.75 years). The state of remission was assessed and recorded regularly throughout treatment and was defined as Pediatric Crohn's Disease Activity Index (PCDAI) <10 for a minimum of three months, with stable, or reduction in, preexisting Crohn's disease medications.

 

 

The median duration of remission was 16 months, with one patient in remission for 76 months at the time of publication. Results of the retrospective analysis also showed a particularly close relationship between treatment with the anti-MAP combination and clinical response in patients naïve to immunosuppression agents commonly used for treatment of Crohn's disease. Adverse events were mild with none necessitating dose adjustment.

 

RedHill has recently initiated a Phase III study in the U.S. with RHB-104 for the treatment of Crohn's disease in adult patients (the MAP US study), and a second Phase III study is planned to commence in Europe by mid-2014 (the MAP Europe study). In addition, RHB-104 was granted in 2011 Orphan Drug Designation from the U.S. Food and Drug Administration (FDA) for the treatment of Crohn's disease in children.

 

 

RHB-104 is a proprietary and potentially groundbreaking combination antibiotic therapy in oral pill formulation, with potent intracellular, antimycobacterial and anti-inflammatory properties. The earlier combination therapy used in the pediatric study, as well as RedHill's new and improved RHB-104 proprietary formulation, are based on increasing evidence supporting the hypothesis that Crohn's disease is caused by MAP infection in susceptible patients rather than being an autoimmune disease.

 

Professor Thomas Borody, the developer of the original RHB-104 formulation, is an unpaid member of RedHill's Advisory Board. He is the founder and medical director of the Centre for Digestive Diseases in Sydney, Australia and is a leading innovator of therapeutic approaches to gastrointestinal tract diseases. Prof. Borody, who also developed the original triple therapy for peptic ulcer disease associated with H. pylori, has published over two hundred studies, articles and book chapters.

 

 

Professor Thomas Borody, MD commented: "This is the first published study describing treatment of pediatric Crohn's disease patients with anti-MAP therapy, and I am very excited with the remarkable results. Reaching a remission rate as high as 80% demonstrates a true potential to substantially improve the lives of young patients suffering from Crohn's disease." Professor Borody added: "There is a significant unmet medical need for novel treatments with new mechanisms of action, and the results from this pediatric study reaffirm my strong belief in this unique antibiotic combination therapy as a new and potentially groundbreaking treatment for Crohn's disease. I am excited by the fact that RedHill Biopharma recently initiated a Phase III study evaluating the safety and efficacy of RHB-104 in adult patients with Crohn's disease.“

 

About RHB-104:

 

 

RHB-104 is a proprietary and potentially groundbreaking combination antibiotic therapy in oral pill formulation, with potent intracellular, antimycobacterial and anti-inflammatory properties. 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 rather than being an autoimmune disease. RHB-104 was originally developed by Professor Thomas Borody, a leading innovator of therapeutic approaches to gastrointestinal tract diseases, who also developed the original triple therapy for peptic ulcer disease associated with H. pylori. Several clinical trials were conducted with earlier formulations of RHB-104, including two Phase II studies, an Australian Phase III study published by Pfizer and several supplementary studies. The formulation of RHB-104 is covered by several issued and pending patents.

 

About Crohn's Disease:

 

Crohn's disease is an inflammatory disease of the gastrointestinal system with significant unmet medical need. The inflammation caused by Crohn's disease can lead to abdominal pain, severe diarrhea, rectal bleeding, weight loss, malnutrition, fever and other symptoms, the range and severity of which vary. There is no known cure for the disease; current treatments are limited to treating the symptoms, are widely considered to be of limited efficacy in the long term, and are associated with numerous side effects. While the onset of Crohn's disease may occur at any age, it is more prevalent among young adults and is commonly described as a 'young person's disease.' The worldwide market of therapies for Crohn's disease is expected to exceed $5 billion in 2013.

 

 

About RedHill Biopharma Ltd.:

 

RedHill Biopharma Ltd. RDHL +2.00% (tase:RDHL) is an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary formulations and combinations of existing drugs. The Company's current product pipeline includes: (i) RHB-101 - a once-daily formulation of a leading congestive heart failure and high blood pressure drug, with a planned NDA submission in the U.S. subject to further CMC and PK work, and a planned Marketing Authorization Application (MAA) in Europe subject to further CMC work; (ii) RHB-102 - a once-daily formulation of a leading chemotherapy and radiotherapy-induced nausea and vomiting prevention drug, planned for U.S. NDA submission in the first quarter of 2014; (iii) RHB-103 - an oral thin film formulation of a leading drug for the treatment of acute migraine, with a U.S. NDA accepted for review by the FDA in June 2013 and a PDUFA date of February 3, 2014; (iv) RHB-104 - a combination antibiotic therapy for the treatment of (a) Crohn's disease, with a first Phase III trial currently underway, (b) multiple sclerosis (MS), with a Phase IIa proof of concept trial currently underway, (c) rheumatoid arthritis (RA), with plans for a Phase IIa proof of concept trial, and (d) systemic lupus erythematosus; (v) RHB-105 - a combination therapy for Helicobacter pylori infection, planned to commence a phase II/III trial shortly, and (vi) RHB-106 - an encapsulated formulation for bowel preparation (laxative) ahead of colonoscopy and other GI procedures.

 

For more information please visit: www.redhillbio.com.

 

http://www.marketwatch.com/story/redhill-biopharmas-rhb-104-combination-achieves-80-remission-in-independent-pediatric-crohns-study-2013-10-15?reflink=MW_news_stmp

 

Crohns: RedHill Biopharma's RHB-104 Achieves 80% Remission in Independent Pediatric Crohn's StudyDynamic Neural Retraining Program (DNRS)

 

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