- First patient has been recruited and dosed in the MAP US study - a randomized, double-blind, placebo-controlled Phase III clinical study to evaluate the safety and efficacy of RHB-104 for treatment of Crohn's disease
- The Phase III study is expected to enroll 240 subjects in over 50 clinical sites in the U.S., Canada and Israel. Subjects will be treated for 52 weeks with a primary endpoint of remission at week 26
- An independent data and safety monitoring board (DSMB) will perform a futility analysis when half the subjects complete the first 26 weeks of blinded treatment
TEL-AVIV, Israel, Nov. 25, 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 that the first patient has been recruited and dosed in the MAP US study - a Phase III clinical study designed to evaluate the safety and efficacy of fixed-dose RHB-104 in patients with moderately to severely active Crohn's disease.
RHB-104 is a proprietary and potentially groundbreaking combination antibiotic therapy in oral capsule 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.
"RHB-104 presents a new and innovative approach to treating Crohn's disease, as it targets a specific pathogen believed to be the cause for the disease, rather than targeting only the symptoms like most standard therapies. We believe that RHB-104 is uniquely positioned due to its dual antibiotic and anti-inflammatory properties," said Ira Kalfus MD, RedHill's Medical Director. "Our efforts are currently focused on subject recruitment, and we are excited by the level of interest in this study by both investigators and patients."
The randomized, double-blind, placebo-controlled Phase III clinical study is expected to enroll 240 subjects with moderately to severely active Crohn's disease in over 50 clinical sites in the U.S., Canada and Israel. Subjects are randomized 1:1 to receive up to five capsules of either RHB-104 or the placebo twice daily for 52 weeks and will be assessed for remission at 26 weeks. Unblinding and assessment of primary and secondary endpoints will be performed after all subjects complete the study.
The primary endpoint for the study is the state of remission at week 26 in subjects randomized to receive RHB-104, compared to subjects randomized to receive the placebo. Secondary and exploratory endpoints include, among others, state of response at 26 weeks, maintenance of remission through week 52, and efficacy outcome measures in relation to the presence of MAP bacterial infection. The study is exploratory with respect to the clinical validation of the Company's proprietary Polymerase Chain Reaction (PCR) assay used to detect MAP. The MAP US Phase III study is registered on www.ClinicalTrials.gov, a web-based service by the U.S. National Institute of Health which provides public access to information on publicly and privately supported clinical studies.
An independent data and safety monitoring board (DSMB) will review safety intermittently throughout the study and will perform a futility analysis when half the subjects complete the first 26 weeks of blinded treatment.
The Company is planning to commence a second Phase III study with RHB-104 for Crohn's disease in Europe (the MAP Europe study) following successful Scientific Advice Meetings with the UK and Swedish pharmaceutical regulatory agencies earlier this year. The MAP Europe study is planned to commence in the first half of 2014 and to be conducted in parallel with the ongoing MAP US study.
RHB-104 is also being evaluated in multiple sclerosis - with an ongoing Phase IIa proof of concept study in Israel, and further clinical studies are being considered for the treatment of rheumatoid arthritis and systemic lupus erythematosus, following successful pre-clinical studies in these indications.
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. The RHB-104 formulation 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 the drug, 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 RedHill Biopharma Ltd.:
RedHill Biopharma Ltd. (Nasdaq:RDHL) (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 pipeline of proprietary products includes: (i) RHB-103 - an oral thin film formulation of a leading drug for the treatment of acute migraines, with a U.S. NDA accepted for review by the FDA in June 2013 and a PDUFA date of February 3, 2014, (ii) RHB-102 - a once-daily oral pill 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-104 - a combination antibiotic therapy in oral capsule formulation, with potent intracellular, antimycobacterial and anti-inflammatory properties 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, (iv) RHB-105 - a combination therapy in oral capsule formulation for Helicobacter pylori infection, with a Phase III trial currently underway, (v) RHB-106 - an encapsulated formulation for bowel preparation (laxative) ahead of colonoscopy and other GI procedures, and (vi) RHB-101 - a once-daily formulation of a leading congestive heart failure and high blood pressure drug. For more information please visit: www.redhillbio.com
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