RHB-102 (Bekinda®) is a proprietary, oral, extended-release (24 hours), once-daily pill formulation of the antiemetic drug ondansetron, under development for multiple indications. 

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 is the most common subtype of IBS in the U.S. 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 understood and the underlying cause of IBS remains unknown. IBS negatively impacts patients’ quality of life and can affect patients physically, emotionally, socially and economically.

RedHill announced positive final results from a randomized, double-blind, placebo-controlled Phase 2 study in the U.S. The study evaluated the efficacy and safety of RHB-102 (Bekinda®) 12 mg in patients with diarrhea-predominant irritable bowel syndrome (IBS-D).

The Phase 2 study successfully met its primary endpoint, improving the primary efficacy outcome of stool consistency response (per FDA guidance definition).