These subjects have the opportunity to receive treatment with RHB-104 for a 52-week period in the open-label MAP US2 extension study.
Red Hill estimates that the development program will be shortened by approximately one year and the Company will benefit from cost savings of approximately $14 million.
RHB-104 is a proprietary, orally-administered, potentially ground-breaking, antibiotic combination therapy with potent intracellular, antimycobacterial and anti-inflammatory properties, targeting a suspected underlying bacterial infectious cause of Crohn’s disease, (MAP). If the MAP US Phase III study results are positive, Red Hill will meet with the FDA and key opinion leaders to present the data package and discuss the preferred development path.
Placebo remission rates in similar, but not identical, pivotal studies in Crohn’s disease range from approximately 7% to approximately 25%.
The Company remains blinded to the data and has no visibility into the actual treatment effect. G., renowned researcher and physician at the Baylor College of Medicine and the lead investigator of the RHB-104 MAP US Phase III study, added: “After reviewing the blinded, blended data from the patients enrolled in the Phase III MAP US study, we found that we could curtail the study and complete it earlier while still maintaining power and treatment effect.
At the second DSMB meeting, held in July 2017, safety and efficacy data from the first 222 subjects who had completed week 26 assessments of the study was reviewed.