About two-thirds of the participants have already completed the study, the company announced.
RHB-104 is an oral antibiotic combination therapy with potent anti-bacterial and anti-inflammatory properties. It is based on the premise that a bacteria causes the immune system dysfunction in Crohn’s disease. Scientists have identified the potential culprit as the Mycobacterium avium species paratuberculosis, or MAP.
The placebo-controlled MAP US Phase 3 trial (NCT01951326) continues to evaluate the safety and effectiveness of RHB-104 in people with moderate to severe Crohn’s. The primary objective of the study is to put the disease into remission, which researchers define as a Crohn’s Disease Active Index score of less than 150 at week 26. RedHill expects the full trial results in mid-2018.
Researchers have enrolled trial participants at 150 sites in the United States, Canada, Israel, Australia, New Zealand, Bulgaria, the Czech Republic, Poland, Serbia, and Slovakia. Patients receive five capsules a day of RHB-104 or a placebo.
An independent review panel, the Data and Safety Monitoring Board, has recommended that RedHill make no changes to its original plan as it continues to conduct the trial.
The first review board meeting in December 2016 looked at whether there were any safety problems with RHB-104. In addition to safety, the second meeting examined the treatment’s effectiveness. At that point, 222 patients had completed the 26 weeks of the trial.
An extension trial, MAP US2 (NCT03009396), has been running parallel with MAP US. It is focusing on patients whose Crohn’s disease is still active at week 26.
The U.S. Food and Drug Administration is likely to ask for data beyond what RedHill has accumulated so far to support the company’s New Drug Application for RHB-104. If the Phase 3 results are promising, RedHill is likely to meet with the FDA to discuss the next steps in the drug’s development plan.
RedHill Biopharma works mostly on the development and commercialization of treatments for gastrointestinal and inflammatory diseases and cancer.