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
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
The 126-patient study was conducted in 16 sites across the
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
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
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
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
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.
About RedHill Biopharma
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential” or similar words. Forward-looking statements are based on certain assumptions and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control and cannot be predicted or quantified, and consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Such risks and uncertainties include, without limitation, the risk that subsequent studies, if conducted at all, will not demonstrate positive data regarding RHB-102 as well as risks and uncertainties associated with (i) the initiation, timing, progress and results of the Company’s research, manufacturing, pre-clinical studies, clinical trials, and other therapeutic candidate development efforts, and the timing of the commercial launch of its commercial products and ones it may acquire or develop in the future; (ii) the Company’s ability to advance its therapeutic candidates into clinical trials or to successfully complete its pre-clinical studies or clinical trials or the development of a commercial companion diagnostic for the detection of MAP; (iii) the extent and number and type of additional studies that the Company may be required to conduct and the Company’s receipt of regulatory approvals for its therapeutic candidates, and the timing of other regulatory filings, approvals and feedback; (iv) the manufacturing, clinical development, commercialization, and market acceptance of the Company’s therapeutic candidates and Talicia®; (v) the Company’s ability to successfully commercialize and promote Talicia®, and Aemcolo® and Movantik®; (vi) the Company’s ability to establish and maintain corporate collaborations; (vii) the Company's ability to acquire products approved for marketing in the
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1 RHB-102 (Bekinda®) is an investigational new drug, not available for commercial distribution.
2 Plasse, Terry F. MD et al; Bimodal Release Ondansetron Improves Stool Consistency and Symptomatology in Diarrhea-Predominant Irritable Bowel Syndrome,
3 For more details, see RedHill’s press releases dated
4 JAMA. 2015;313(9):949-958.
6 Lovell RM, Ford AC. Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis. Clin Gastroenterol Hepatol. 2012;10(7):712-72 doi: 10.1016/j.cgh.2012.02.029.
7 Full prescribing information for Movantik® (naloxegol) is available at: www.Movantik.com.
8 Full prescribing information for Talicia® (omeprazole magnesium, amoxicillin and rifabutin) is available at: www.Talicia.com.
9 Full prescribing information for Aemcolo® (rifamycin) is available at: www.Aemcolo.com.
Source: RedHill Biopharma Ltd.