RedHill Biopharma announced data from its Phase 2 study of RHB-102 (Bekinda), a novel, proprietary, once-daily, 12mg bimodal-release ondansetron for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D), have been published in The American Journal of Gastroenterology.
The study was conducted in 16 sites across the U.S and included 126 patients, aged 18 and older, who met the Rome III criteria for IBS-D and had a Bristol Stool Scale rating of at least six on two or more days weekly. Patients were randomly assigned at a 3:2 ratio to receive either RHB-102 (n = 75) or placebo (n = 51) once daily for eight weeks. The primary outcome measure of the study was overall stool consistency response for at least four of eight weeks. RHB-102 delivered a response rate in stool consistency of 56.0% compared to 35.3% in the placebo group. The treatment effect, the difference between response rates in patients receiving RHB-102 compared to those receiving placebo, was greater in patients with baseline CRP levels above the median for this study. This suggests that CRP may be a predictor of response. RHB-102 also demonstrated favorable outcomes versus placebo in the secondary endpoints of overall pain response (50.7% vs 39.2%) and composite response rates (40.0% vs 25.5%). RHB-102 was well tolerated with similar rates of adverse events reported for both arms of the study.
RedHill is currently finalizing the design of two pivotal Phase 3 studies utilizing RHB-102 for IBS-D.
About RHB-102 (Bekinda)
RHB-102 is a proprietary investigational bimodal release, once-daily formulation of ondansetron that is unique in its ability to combine immediate release ondansetron, for fast symptom relief, with a slow-release matrix, that maintains therapeutic effect for up to 24 hours.
About Irritable Bowel Syndrome
IBS is a common disorder that affects the large intestine. Signs and symptoms include cramping, abdominal pain, bloating, gas, and diarrhea or constipation, or both. IBS is a chronic condition that needs to be managed long term. According to the American College of Gastroenterology it is the most common disease diagnosed by gastroenterologists and one of the most common disorders seen by primary care physicians in the U.S. IBS-D accounts for around 40% of all IBS sufferers. It has a significant impact on quality of life, causing symptoms such as pain and cramping, in addition to urgency and diarrhea.