RedHill Biopharma has finished patient enrolment in a Phase III clinical trial (MAP US) of RHB-104 being evaluated for the treatment of Crohn’s disease.
Formulated for oral administration, RHB-104 is an antibiotic combination therapy said to possess intracellular, anti-mycobacterial and anti-inflammatory properties.
Being conducted at around 150 clinical sites across the US, Canada, Europe, Israel, Australia and New Zealand, the randomised, double-blind, placebo-controlled Phase III trial enrolled a total of 331 subjects.
Designed to investigate the safety and efficacy of RHB-104 in patients suffering from moderate to severely active Crohn’s disease, the trial will assess disease remission as the primary endpoint.
The firm is also conducting an open-label extension Phase III MAP US2 study to monitor the safety and efficacy of RHB-104 in subjects who remain with active Crohn’s disease following 26 weeks of treatment in the MAP US trial.
Patients will be treated for an additional period of 52 weeks during the extension study, with its primary endpoint being disease remission at week 16.
The MAP US2 study is set to recruit about 50-70 patients in the US, Canada, Europe, Israel, and New Zealand.
Top-line results from the Phase III MAP US trial are scheduled to be available mid-2018, with plans for additional open-label studies to support future marketing applications of RHB-104.
In the first half of next year, RedHill Biopharma intends to commence a Phase III trial of RHB-104 for treating non-tuberculous mycobacteria (NTM) infections in the US.