RedHill Biopharma Publishes Positive IBS-D Phase 2 Study Data in The American Journal of Gastroenterology
Publication of the Phase 2 U.S. study data show that RHB-102 (Bekinda®) 12mg delivers a clinically meaningful improvement in overall stool consistency response versus placebo in patients with diarrhea-predominant irritable bowel syndrome (IBS-D), meeting the study’s primary endpoint
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In addition, the publication highlights that elevated baseline C-reactive protein (CRP) may be used to identify treatment responders in this complex disease, which lacks reliable predictive markers
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The 126-patient study was conducted in 16 sites across the U.S.
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RHB-102, a novel, proprietary, once-daily bimodal release formulation of ondansetron that allows for both immediate relief and 24-hour maintenance of effect, is also in Phase 3 development for acute gastroenteritis and gastritis
TEL AVIV, Israel and RALEIGH, N.C., July 28, 2020 (GLOBE NEWSWIRE) -- 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.
About Irritable Bowel Syndrome
Irritable bowel syndrome (IBS) is a complex and debilitating condition, reported to affect in excess of 10% of Americans4. 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.5. IBS-D accounts for around 40% of all IBS sufferers6. It has a significant impact on quality of life, causing symptoms such as pain and cramping, in addition to urgency and diarrhea.
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.
Following the successful Phase 2 study of RHB-102 (12mg) in IBS-D, RedHill is currently finalizing the design of two pivotal Phase 3 studies for IBS-D.
RedHill is also developing RHB-102 as a (24mg) formulation, for acute gastroenteritis and gastritis. The Phase 3 GUARD study with RHB-102 (24mg) in acute gastroenteritis and gastritis successfully met its primary endpoint of prevention of vomiting for at least 24 hours in adolescent and adult patients with gastroenteritis-related emesis without the use of IV hydration or rescue medication. The Company is currently working towards a confirmatory Phase 3 study to support a potential New Drug Application (NDA) for this indication. RHB-102 is covered by several issued and pending patents.
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