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The Company is assessing the possibility of a Phase IIa proof of concept study in systemic lupus erythematosus as a next step
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RedHill expects to commence a Phase III study with RHB-104 for Crohn’s disease in the U.S. during the third quarter of 2013 (the MAP US study), and plans a second Phase III study for Crohn’s in Europe (the MAP Europe study)
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Patients recruitment is underway in a Phase IIa study with RHB-104 for multiple sclerosis (MS)
TEL-AVIV, Israel I September 10, 2013 I RedHill Biopharma Ltd. (RDHL) (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 systemic lupus erythematosus (SLE), a systemic autoimmune disease causing inflammation and damage to tissues in various parts of the body. In light of the positive results, the Company is currently assessing the next steps in the clinical development program, including a possible Phase IIa clinical study.
The pre-clinical study was designed to evaluate the potential therapeutic effects of RHB-104 on disease development in an experimental SLE model when administered orally.
The results from the pre-clinical study demonstrated that disease severity and overall disease development were reduced in the RHB-104 arm, indicating that RHB-104 was efficacious in reducing the development of SLE in this study.
SLE is an autoimmune disease in which the body’s immune system attacks healthy cells and tissues resulting in inflammation and possible harm to multiple organs and organ systems including joints, skin, kidneys, blood, brain, heart and lungs. Symptoms of SLE may vary accordingly. The underlying cause of SLE is unknown and there is no cure for the disease, thus available therapies are aimed at controlling the symptoms. Worldwide sales of SLE therapies are estimated to have exceeded $370 million in 20121.
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 antibacterial activity against intracellular infections. RHB-104 is 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 (the MAP US study) and a planned Phase III study in Europe (the MAP Europe study), the treatment of multiple sclerosis – with an ongoing phase IIa proof of concept study, and the treatment of rheumatoid arthritis – with a planned Phase IIa proof of concept study.
Dr. Reza Fathi, RedHill’s Senior VP R&D, commented: “We are very pleased with the results of the pre-clinical study conducted with RHB-104 in the treatment of systemic lupus erythematosus. The results of this study are consistent with the hypothesis that a dysregulated immune system response to bacterial origin in genetically predisposed individuals plays a role in the pathogenesis of various autoimmune diseases for which there is no available cure, such as Crohn’s disease, multiple sclerosis, rheumatoid arthritis and lupus. We are currently assessing next steps in the development program, including the possibility of a Phase IIa proof of concept clinical study with RHB-104 for the treatment of systemic lupus erythematosus.”
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (RDHL) (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 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, rheumatoid arthritis (RA), with plans for a Phase IIa proof of concept trial, and systemic lupus erythematosus; (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
SOURCE: Redhill
Post Views: 195
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The Company is assessing the possibility of a Phase IIa proof of concept study in systemic lupus erythematosus as a next step
-
RedHill expects to commence a Phase III study with RHB-104 for Crohn’s disease in the U.S. during the third quarter of 2013 (the MAP US study), and plans a second Phase III study for Crohn’s in Europe (the MAP Europe study)
-
Patients recruitment is underway in a Phase IIa study with RHB-104 for multiple sclerosis (MS)
TEL-AVIV, Israel I September 10, 2013 I RedHill Biopharma Ltd. (RDHL) (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 systemic lupus erythematosus (SLE), a systemic autoimmune disease causing inflammation and damage to tissues in various parts of the body. In light of the positive results, the Company is currently assessing the next steps in the clinical development program, including a possible Phase IIa clinical study.
The pre-clinical study was designed to evaluate the potential therapeutic effects of RHB-104 on disease development in an experimental SLE model when administered orally.
The results from the pre-clinical study demonstrated that disease severity and overall disease development were reduced in the RHB-104 arm, indicating that RHB-104 was efficacious in reducing the development of SLE in this study.
SLE is an autoimmune disease in which the body’s immune system attacks healthy cells and tissues resulting in inflammation and possible harm to multiple organs and organ systems including joints, skin, kidneys, blood, brain, heart and lungs. Symptoms of SLE may vary accordingly. The underlying cause of SLE is unknown and there is no cure for the disease, thus available therapies are aimed at controlling the symptoms. Worldwide sales of SLE therapies are estimated to have exceeded $370 million in 20121.
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 antibacterial activity against intracellular infections. RHB-104 is 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 (the MAP US study) and a planned Phase III study in Europe (the MAP Europe study), the treatment of multiple sclerosis – with an ongoing phase IIa proof of concept study, and the treatment of rheumatoid arthritis – with a planned Phase IIa proof of concept study.
Dr. Reza Fathi, RedHill’s Senior VP R&D, commented: “We are very pleased with the results of the pre-clinical study conducted with RHB-104 in the treatment of systemic lupus erythematosus. The results of this study are consistent with the hypothesis that a dysregulated immune system response to bacterial origin in genetically predisposed individuals plays a role in the pathogenesis of various autoimmune diseases for which there is no available cure, such as Crohn’s disease, multiple sclerosis, rheumatoid arthritis and lupus. We are currently assessing next steps in the development program, including the possibility of a Phase IIa proof of concept clinical study with RHB-104 for the treatment of systemic lupus erythematosus.”
About RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (RDHL) (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 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, rheumatoid arthritis (RA), with plans for a Phase IIa proof of concept trial, and systemic lupus erythematosus; (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
SOURCE: Redhill
Post Views: 195
