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, orally administered antibiotic combination therapy, with intracellular, antimycobacterial and anti-inflammatory properties.
RHB-104, an investigational drug, 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 and presented the potential benefit of RHB-104 as an add-on therapy to standard-of-care treatments for Crohn’s disease, including anti-TNF agents. Recent
potential progress in Mycobacterium avium subspecies paratuberculosis
(MAP) diagnostic technology may enable advancement towards a confirmatory study
in MAP positive moderate-severe Crohn’s patients, subject to validation and required
regulatory input.
The company 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.