RedHill Biopharma’s RHB-104 orally-administered antibiotic combination therapy has achieved its primary endpoint and key secondary endpoints in phase III Crohn’s disease study.
The company has announced the positive top-line safety and efficacy results from the MAP US study, which showed superiority of RHB-104 over placebo.
RHB-104 is a proprietary and orally-administered antibiotic combination therapy with potent intracellular, antimycobacterial and anti-inflammatory properties.
RedHill medical director Ira Kalfus said: “The robust results of this study demonstrate that RHB-104 could become a leading therapeutic option in Crohn’s disease and bring hope to patients worldwide.”
“This is the first global, double-blind, placebo-controlled study that demonstrates the efficacy of anti-MAP therapy in Crohn’s disease.”
The top-line results in the intent-to-treat (ITT) population showed superiority of RHB-104 over placebo in achieving remission at week 26, defined as Crohn’s Disease Active Index (CDAI) value of less than 150, the primary endpoint of the study.
RedHill’s study also achieved key secondary endpoints, showing consistent benefit to Crohn’s disease patients treated with RHB-104.
The RHB-104’s randomized, double-blind and placebo-controlled first Phase III study recruited 331 subjects with moderately to severely active Crohn’s disease in the US, Canada, Europe, Australia, New Zealand and Israel.
Subjects have been randomized 1:1 to secure RHB-104 or placebo, on-top of baseline background medication including of 5-ASAs, corticosteroids, immunomodulators or anti-TNFα agents.
The company is also currently conducting an open-label extension Phase III study called as MAP US2 study to assess the safety and efficacy of RHB-104 in subjects who remain with active Crohn’s disease (CDAI ≥ 150) after 26 weeks of blinded study therapy in the Phase III MAP US study.
In addition, the firm completed a phase IIa proof-of-concept clinical study assessing RHB-104 as an add-on therapy to interferon beta-1a in subjects treated for relapsing-remitting multiple sclerosis (CEASE MS study).
RedHill CEO Dror Ben-Asher said: “We thank the patients who participated in this global study, as well as the physicians and clinical staff who supported them. We also want to extend our deep gratitude to the lead investigator of the study, Professor David Graham, to the RedHill team and to the experts and vendors for their commitment throughout the study.”