RedHill Biopharma has announced positive results from the first Phase III study of its Crohn's disease drug RHB-104 - making it the first global, double-blind, placebo-controlled study to demonstrates the efficacy of anti-MAP therapy in this hard-to-treat disease area..

“The availability of antibiotic therapy for treating Crohn’s disease could be transformative,” said Ira Kalfus, RedHill’s medical director. “The results from the MAP US study are excellent, successfully meeting the primary endpoint at week 26 and demonstrating that treatment with RHB-104 also has an early benefit at week 16, which is persistent though week 52. The study results compare favourably to existing standard-of-care therapies.”

Top-line results in the intent-to-treat (ITT) population demonstrated 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. The proportion of patients meeting the primary endpoint was significantly greater in the RHB-104 group compared to placebo (37% vs. 23%, p= 0.013).

Patients treated with RHB-104 also achieved a statistically significant greater response at week 26 (defined as a decrease of ≥100 in CDAI from baseline) compared to placebo (44% vs. 31%, p= 0.028), as well as a statistically significant benefit in achieving early remission defined as remission at week 16 (42% vs. 29%, p= 0.019).

At 52 weeks of treatment, remission in the RHB-104 arm continued to be favourable to placebo (27% vs. 20%, p= 0.155).
Professor David Graham, lead investigator of the study, added: “I am impressed and extremely pleased with the results of the study, which indicate that RHB-104 could lead to a paradigm shift in the treatment of Crohn’s disease, a chronic and debilitating and currently incurable condition with a strong unmet medical need.

“Many patients with Crohn’s disease do not achieve remission on current standard-of-care therapies, which are accompanied with poor side effects. RHB-104 appears to have the potential to become a promising, new, orally-administered therapy for this important debilitating disease.”

As of 2017, approximately 1.5 million people worldwide had been diagnosed with Crohn's disease. Global sales of Crohn’s disease therapies are estimated to exceed $10 billion in 2018.