RedHill Biopharma Initiates Phase II Study of BEKINDA(TM) for Irritable Bowel Syndrome - Seite 2

The randomized, double-blind, 2-arm parallel group Phase II clinical study is designed to evaluate the safety and efficacy of BEKINDA(TM) 12 mg in patients suffering from IBS-D. The study is expected to be conducted in 12 clinical sites in the U.S. and to enroll 120 patients who will be randomized 60:40 to receive either BEKINDA(TM) 12 mg or a placebo, once daily, for a period of eight weeks. The primary endpoint for the study is the proportion of patients in each treatment group with response in stool consistency as compared to baseline, per FDA guidance definition. Secondary endpoints include the proportion of patients in each treatment group who are pain responders and the proportion of patients in each treatment group who are responders to the combined endpoints of stool consistency and pain, per FDA guidance definition.

Irritable bowel syndrome (IBS) is a chronic multifactorial disorder characterized by recurrent abdominal pain or discomfort associated with altered bowel function. Diarrhea-predominant irritable bowel syndrome (IBS-D) is the most common subtype of IBS in the U.S.4 Certain factors that may alter gastrointestinal function can contribute to IBS symptoms, including stress, prior gastroenteritis and changes in the gut microbiome. However, the etiology of IBS is not well-understood and the underlying cause of IBS in many cases remains unknown. IBS negatively impacts patients' health-related quality of life and can affect patients physically, emotionally, socially and economically.

IBS is one of the most common GI disorders; it is estimated that at least 30 million Americans suffer from IBS5, of which over 50% are cases of IBS-D4. The U.S. potential market for IBS-D treatments is estimated to exceed $1.3 billion by 20206.

About BEKINDA(TM) (RHB-102):
BEKINDA(TM) is a patent-protected, extended-release (24 hours) oral pill formulation of ondansetron. A Phase III clinical study of BEKINDA(TM) for acute gastroenteritis and gastritis (the GUARD study) is ongoing in the U.S., with top-line results expected in the second half of 2016. A Phase II study has been initiated with BEKINDA(TM) for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). RedHill is also pursuing marketing approval of BEKINDA(TM) in Europe for the prevention of chemotherapy and radiotherapy-induced nausea and vomiting (CINV and RINV, respectively), pending additional feedback from EU member states as to whether additional clinical and CMC work is required.