- An independent review and analysis of the final results, provided to the Company, confirmed that the Phase II study with BEKINDA ® 12 mg successfully met its primary endpoint, improving the primary efficacy outcome of stool consistency (per FDA guidance definition) by an absolute difference of 20.7% vs. placebo (p-value=0.036). The final top-line results improve upon the previously announced top-line results (absolute difference of 19.4%, p-value=0.05).
- Results from the BEKINDA ® Phase II study suggest that they compare favorably with previously reported efficacy outcome values from studies of Xifaxan ® (rifaximin) and Viberzi ® (eluxadoline) across all three efficacy endpoints 3.
- The randomized, double-blind, placebo-controlled Phase II study evaluated the efficacy and safety of BEKINDA ® 12 mg in 126 subjects over 18 years old in the U.S., who received either BEKINDA ® 12 mg or placebo, once daily, for a period of eight weeks.
- IBS is one of the most common gastrointestinal disorders 4, affecting an estimated 30 million Americans, of which approximately 40% are estimated to be cases of IBS-D 5; The U.S. market of IBS-D therapies grew by approximately 550% between 2013-2016 6.
- RedHill plans to meet with the FDA in the first half of 2018 to discuss the design for one or two pivotal Phase III studies with BEKINDA® 12 mg for IBS-D.
|Company contact:Adi FrishSenior VP Business Development & Licensing RedHill Biopharma+972-54-6543-112 email@example.com||IR contact (U.S.): Marcy NanusSenior Vice President The Trout Group+1-646-378-2927 Mnanus@troutgroup.com|
1 Final top-line results remain subject to the Clinical Study Report (CSR).2 BEKINDA ® is an investigational new drug, not available for commercial distribution. 3 For more details see RedHill's press release dated October 3, 2017. Xifaxan® (rifaximin) prescribing information: www.accessdata.fda.gov/drugsatfda_docs/label/2010/022554lbl.pdf; Viberzi® (eluxadoline) prescribing information: www.accessdata.fda.gov/drugsatfda_docs/label/2015/206940s000lbl.pdf; Average absolute difference from reported Phase III studies; The theoretical comparison between the BEKINDA ® 12 mg Phase II study results and reported data from studies of IBS-D-approved therapies serves as a general benchmark for the effect size observed with BEKINDA ® 12 mg and should not be construed as a direct and/or equal comparison given that the studies were not identical in design, patient population and treatment period. For example, in the Xifaxan ® 550 mg Phase III studies, the referenced efficacy endpoints were evaluated over a period of 4 weeks after 2 weeks drug administration, and in the Viberzi ® 100 mg Phase III studies the referenced efficacy endpoints were evaluated after drug was administered and evaluated for 12 weeks. The studies were not conducted head-to head in the same patient population. 4 GlobalData PharmaPoint: Irritable Bowel Syndrome - Global Drug Forecast and Market Analysis to 2023. 5 Lovell RM, Ford AC, Global prevalence of and risk factors for irritable bowel syndrome: a meta-analysis, Clin Gastroenterol Hepatol (2012), 10(7)712-721; Saito YA et al, The epidemiology of irritable bowel syndrome in North America: a systemic review, Am J Gastroenterol (2002), 97(8): 1910-5. 6 EvaluatePharma - USA sales by indication (IBS-D) (July 2017).