Effecting an estimated one million Americans, Crohn's disease can be highly debilitating and remains a serious burden for both patients and healthcare systems.
RHB-104 is a proprietary, oral, investigational, antibiotic combination therapy, with intracellular, antimycobacterial and anti-inflammatory properties.
RHB-104 was developed based on the hypothesis that Crohn’s disease is caused by Mycobacterium avium subspecies paratuberculosis (MAP) infection in susceptible patients. The development of RHB-104 is consistent with the growing awareness of the possibility that a bacterially-induced dysregulated immune system may contribute to the pathogenesis of various autoimmune diseases of unknown etiology.
A randomized, double-blind, placebo-controlled, Phase 3 study with RHB-104 in Crohn’s disease (the MAP US study) successfully met both its primary endpoint and key secondary endpoints. The study results, which were published in the Antibiotics journal, showed the potential benefit of RHB-104 as an add-on therapy to standard-of-care treatments for Crohn’s disease, including anti-TNF agents. Potential progress in Mycobacterium avium subspecies paratuberculosis
(MAP) diagnostic technology may enable advancement toward a confirmatory study
in MAP positive moderate-to-severe Crohn’s patients.
RedHill also reported supportive top-line results from an open-label extension Phase 3 study (MAP US2) evaluating the safety and efficacy of RHB-104 in subjects with persistent active Crohn’s disease after 26 weeks of blinded study therapy in the MAP US study.
Read more about the study results here.