On March 27, 2018 RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary drugs for gastrointestinal diseases and cancer, reported that two abstracts1 related to the successful Phase III study with BEKINDA (RHB-102)2 24 mg for acute gastroenteritis and gastritis (the GUARD study) have been accepted for oral presentations at the Society for Academic Emergency Medicine (SAEM) 2018 Annual Meeting, May 16-17, 2018, at the JW Marriott Hotel in Indianapolis, IN (Press release, RedHill Biopharma, MAR 27, 2018, View Source [SID1234525013]).
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The randomized, double-blind, placebo-controlled Phase III GUARD study with BEKINDA 24 mg successfully met its primary endpoint of efficacy in the treatment of acute gastroenteritis and gastritis, and BEKINDA 24 mg was found to be safe and well tolerated in this indication3. If approved for marketing by the FDA, BEKINDA 24 mg could become the first 5-HT3 antiemetic drug in the U.S. indicated for the treatment of acute gastroenteritis and gastritis.
The first presentation, entitled ‘Treatment of Acute Gastroenteritis-Related Emesis with Bimodal Release Ondansetron (RHB-102)’, will be presented by Robert Silverman, MD, MS, Associate Professor of Emergency Medicine, Zucker School of Medicine at Hofstra/Northwell; Northwell Health, and Lead Investigator of the BEKINDA Phase III GUARD study, on Wednesday, May 16, 2018, at 3:00 PM EDT. The abstract concludes that the Phase III GUARD study is the first study of acute gastroenteritis-related emesis showing benefit from any ondansetron preparation in adolescents and adults and suggests that acute gastroenteritis can be treated with a long-acting, bimodal release tablet, potentially avoiding the need for intravenous access.
The second presentation, entitled ‘A 24 mg bimodal-release ondansetron pill (RHB-102) shows no evidence of QT interval prolongation’, will be presented by Joseph Miller, MD, MS, Associate Clinical Professor, Emergency Medicine, Henry Ford Hospital and Investigator of the BEKINDA Phase III GUARD study, on Thursday, May 17, 2018, from 9:00 AM EDT. The abstract concludes that in patients with normal baseline corrected QT interval (QTc), 24 mg bimodal extended-release ondansetron caused no QTc prolongation in comparison to placebo.
About BEKINDA (RHB-102):
BEKINDA is a proprietary, bimodal extended-release (24 hours) oral pill formulation of ondansetron, covered by several issued and pending patents and targets several gastrointestinal indications. A first Phase III clinical study with BEKINDA 24 mg for the treatment of acute gastroenteritis and gastritis (the GUARD study) successfully met its primary endpoint. A Phase II study with BEKINDA 12 mg for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D) successfully met its primary endpoint.