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RedHill Biopharma Announces Positive Pre-Clinical Rheumatoid Arthritis Results With RHB-104 And Plans For A Phase IIa Study

  • The planned phase IIa, proof of concept, clinical study will assess the efficacy and safety of RHB-104 in patients suffering from rheumatoid arthritis (RA)
  • RA is one of the most common inflammatory diseases, with 2012 w orldwide sales of therapies exceeding $20 billion
  • A Phase III clinical study with RHB-104 for Crohn's disease is in final preparations
  • A Phase IIa, proof of concept, clinical study with RHB-104 for multiple sclerosis (MS) is ongoing

TEL-AVIV, Israel, July 30, 2013 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (Nasdaq:RDHL) (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, 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 2012 1. It is estimated that the prevalence of RA ranges from 0.5% to 1% of the general population 2 with an estimated 1.5 million people affected by the disease in the U.S. alone 3. The prevalence of RA increases with age and is more common among women 4. 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.

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