RedHill Biopharma announced the publication of a peer-review article demonstrating the potential efficacy of RHB-104 for the treatment of Mycobacterium avium subspecies paratuberculosis (MAP) infection-associated Crohn’s disease.
The article was authored by researchers from the Burnett School of Biomedical Sciences at the University of Central Florida (UCF) College of Medicine and titled “RHB-104 triple antibiotics combination in culture is bactericidal and should be effective for treatment of Crohn’s disease associated with Mycobacterium paratuberculosis.” The study was published in the journal Gut Pathogens.
RHB-104 is a patented oral antibiotic combination therapy with strong properties at the intracellular, anti-mycobacterial and anti-inflammatory levels. RHB-104 was grounded on emerging evidence that supports the hypothesis that Crohn’s disease is caused by MAP infections in susceptible patients.
The article describes a preclinical study designed to evaluate the efficacy of RHB-104 active components (antibiotics clarithromycin, clofazimine and rifabutin) against MAP strains isolated from Crohn’s patients’ blood, tissue and milk.
The preclinical study’s results showed that the active components of RHB-104, individually or dually combined, were not as effective against all microorganisms as triple combinations at minimum inhibitory concentration levels.
Based on the results, the research team concluded that lower concentrations of the triple active components combination in RHB-104 could provide a better synergy against MAP growth activity. Consequently, the authors recommend the administration of RHB-104 for long-term treatment of Crohn’s disease.
“We are pleased with the important findings described in this article which provide further validation of the synergistic activity and potential efficacy of RHB-104 in eradicating Mycobacterium avium subspecies paratuberculosis, or MAP, – a suspected etiological agent of Crohn’s disease and possibly additional autoimmune, inflammatory and mycobacterial diseases,” Reza Fathi, RedHill’s senior vice president of Research & Development, in a press release. “The results from this study suggest that RHB-104, if approved, could become a new and effective therapy for the treatment of Crohn’s disease.”
RHB-104 is currently in a first randomized, double-blind, placebo-controlled Phase 3 clinical trial titled “Efficacy and Safety of Anti-MAP Therapy in Adult Crohn’s Disease (MAP US)” evaluating the drug candidate’s performance in the treatment of Crohn’s disease. The study is taking place in the United States, Canada, Israel and Australia, among some additional countries. Interim data is expected in the second half of 2016, after 50% of the 270 patients enrolled in the study will have completed 26 weeks of treatment.
Recently, RedHill Biopharma received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for its patent covering RHB-104.
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