RHB-104 is a proprietary and potentially groundbreaking antibiotic combination therapy in oral capsule formulation, with potent intracellular, antimycobacterial and anti-inflammatory properties.
Crohn’s disease is an inflammatory disease of the gastrointestinal system with significant unmet needs. 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. Current therapies target symptomatic relief, are widely considered to be of limited efficacy in the long term, and are associated with numerous side effects.
The development of 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.
RedHill is currently conducting a Phase III clinical study in the U.S., Canada, Europe, Israel, Australia and New Zealand. The study is designed to evaluate the safety and efficacy of fixed-dose RHB-104 in patients with moderately to severely active Crohn's disease (the MAP US study).
A first DSMB safety-focused meeting recommended unanimously that the study continue as planned (Dec. 2016). A second independent DSMB meeting is expected in mid-2017, when half of the 410 patients expected to be enrolled in the study will have completed 26 weeks of study participation; This independent DSMB review will include safety and interim efficacy analysis, with evaluation of an early stop for success under pre-specified efficacy criteria. The primary endpoint for the study is remission at week 26 of treatment.
The MAP US 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.
Several clinical trials were conducted with earlier formulations of RHB-104, including an Australian Phase III study conducted by Pfizer. RedHill has conducted several supportive studies with the current formulation of RHB-104 and a long-term population pharmacokinetic (Pop-PK) study is ongoing as part of the Phase III MAP US study. The formulation of RHB-104 is covered by several issued and pending patents.
As part of its development efforts for RHB-104, RedHill is developing, in collaboration with Quest Diagnostics, a diagnostic test to aid in detecting the presence of MAP (Mycobacterium avium paratuberculosis) in whole blood. In January 2015 RedHill and Quest Diagnostics concluded a pre-submission meeting with the FDA regarding the development path of a commercial companion diagnostic test for the detection of MAP in Crohn’s disease patients. Ongoing work on RedHill’s companion MAP diagnostic test has led to the successful identification of MAP DNA in blood samples from Crohn’s disease patients; Further development work on the MAP companion diagnostic is in progress
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