MedicalResearch.com Interview with:
Co-Founder, Chairman & CEO
RedHill Biopharma Ltd.
MedicalResearch.com: Your presentation at United European Gastroenterology Week (UEGW) covered top-line data from your recently completed Phase 3 study of RHB-104 in Crohn’s disease. Can you please briefly remind us of the background for this study and what results you previously announced?
Response: Crohn’s disease is a devastating gastrointestinal disorder that affects millions of people worldwide. Crohn’s is a chronic relapsing disorder that plagues people throughout their lives with a variety of symptoms including severe abdominal pain, diarrhea, bleeding, bowel obstruction, fever and weight loss. The existing treatments for Crohn’s disease leave a lot to be desired – they are only partially effective in the long-term control of Crohn’s and are associated with serious side effects. In addition, the existing therapies only target treating the symptomatic inflammation associated with Crohn’s.
We began developing RHB-104 with the MAP hypothesis in mind, a theory that suggests Crohn’s is caused by infection by a bacteria, Mycobacterium avium subspecies paratuberculosis (MAP), in susceptible patients. RHB-104 is a patent-protected orally-administered combination of three antibiotics (clarithromycin, clofazimine and rifabutin) in a single oral capsule that has demonstrated its potential to benefit Crohn’s patients.
When we announced top-line results from the MAP US study, our Phase 3 trial of RHB-104 in patients with moderate to severe Crohn’s disease, we showed that RHB-104 demonstrated a significant clinical benefit to patients versus placebo control. Patients treated with RHB-104 showed significant increase in remission at 26-weeks post treatment initiation in addition to being generally safe and well tolerated. Continue reading