RedHill Biopharma Ltd. (NASDAQ:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company, today announced the publication of data from its previously announced Phase 2 study of RHB-102 (Bekinda®)1, a novel, proprietary, once-daily, 12mg bimodal-release ondansetron, in diarrhea-predominant irritable bowel syndrome (IBS-D), in The American Journal of Gastroenterology.
The peer-reviewed article2, entitled “Bimodal Release Ondansetron Improves Stool Consistency and Symptomatology in Diarrhea-Predominant Irritable Bowel Syndrome, A Randomized, Double-Blind, Trial,” is available online.
“The newly published positive data in patients who received RHB-102 for IBS-D, are a demonstration of RedHill’s ongoing ability to successfully execute its R&D programs to meet specified endpoints. The data are particularly encouraging given the need for new treatment options, that demonstrate both effectiveness and tolerability, in this challenging condition that significantly impacts quality of life,” said Terry Plasse, MD, Medical Director at RedHill and lead author of the publication. “In addition to the positive efficacy data, an important finding reported in the publication was the identification of baseline CRP as a potential predictive marker of RHB-102 treatment response in IBS-D, which could be a major benefit in future trials and commercialization. We intend to continue realizing the potential of RHB-102 for IBS-D patients.”
The publication reports that RHB-102 delivered a response rate in stool consistency of 56.0% compared to 35.3% in the placebo group (P = .036). 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. While not powered to show statistical significance, RHB-102 also demonstrated favorable outcomes 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.
The Phase 2 study, conducted in 16 sites across the U.S., included 126 male and female 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.
Results from the study, according to a Company analysis, suggest that outcomes for RHB-102 compare favorably with previously reported efficacy outcome values from studies of Xifaxan® (rifaximin) and Viberzi® (eluxadoline), across all three efficacy endpoints3.