RedHill Biopharma Announces Positive Pre-Clinical Rheumatoid Arthritis Results With RHB-104 and Plans for a Phase IIa Study

RedHill Biopharma

an emerging Israeli biopharmaceutical company focused primarily on the development and acquisition of late clinical-stage, proprietary formulations and combinations of existing drugs, today announced positive results from a pre-clinical study with RHB-104 for the treatment of rheumatoid arthritis (RA), one of the most common chronic inflammatory diseases. In light of these positive results, the Company plans to conduct a phase IIa, proof of concept, clinical study to assess the efficacy and safety of RHB-104 in patients suffering from RA. The pre-clinical study was designed to evaluate the potential therapeutic effects of RHB-104 using the Collagen-Induced Arthritis (CIA) pre-clinical model, the most commonly studied autoimmune model of RA. The results from the pre-clinical study demonstrated that disease severity was significantly reduced in the RHB-104 arm, indicating that RHB-104 was effective in treating CIA in the study. RA is a systemic chronic inflammatory disease considered to be one of the most prevalent immune-mediated inflammatory diseases, with worldwide sales of RA therapies estimated to have exceeded $20 billion in 20121. It is estimated that the prevalence of RA ranges from 0.5% to 1% of the general population2 with an estimated 1.5 million people affected by the disease in the U.S. alone3. The prevalence of RA increases with age and is more common among women4. RA is nearly always polyarticular and causes joint destruction, deformity, and loss of function. Extra-articular manifestations include cardiopulmonary diseases, eye diseases, Sjogren's syndrome, rheumatoid vasculitis and neurological diseases. There is no known cure for RA. Common therapies treat the symptoms of the disease and are considered of limited efficacy in the long term. RHB-104 is a patent protected combination therapy of three antibiotics in a single oral capsule. It is a multifaceted drug with potentially distinct anti-inflammatory and neuroprotective properties, in addition to its bactericidal activity against intracellular infections. RHB-104 is also being evaluated for the treatment of Crohn's disease, with a phase III clinical study planned to commence in the third quarter of 2013 in the U.S., Canada and Israel, and for the treatment of multiple sclerosis, with an ongoing phase IIa proof of concept study. Dr. Reza Fathi, RedHill's Senior VP R&D, commented: "We are delighted with the outcome of the pre-clinical study conducted with RHB-104 for rheumatoid arthritis. We plan to advance our clinical development program towards a phase IIa, proof of concept, clinical study to assess the efficacy and safety of RHB-104 in patients suffering from rheumatoid arthritis. The planned Phase III clinical study with RHB-104 for Crohn's disease, the ongoing Phase IIa study in multiple sclerosis and the planned Phase IIa study in rheumatoid arthritis, are designed to test a new and innovative hypothesis, that a bacterial induced dysregulated immune system plays a critical role in the pathogenesis of these diseases, all of which exhibit characteristics of both infectious and autoimmune pathology." About RedHill Biopharma Ltd.: RedHill Biopharma Ltd.

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 therapy for the treatment of Crohn's disease, planned to commence a first Phase III trial in the third quarter of 2013, multiple sclerosis (MS), with a Phase IIa proof of concept trial currently underway, and plans for a Phase IIa proof of concept trial in rheumatoid arthritis (RA); (v) RHB-105 - a combination therapy for Helicobacter pylori infection, planned to commence a phase II/III trial in the third quarter of 2013, 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