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.”