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ARTICLE | Clinical News

RedHill's Bekinda meets in Phase III gastroenteritis trial

June 30, 2017 7:01 PM UTC

RedHill Biopharma Ltd. (Tel Aviv:RDHL; NASDAQ:RDHL) reported top-line data from the Phase III GUARD trial in 321 patients ages >12 with acute gastroenteritis and gastritis showing that once-daily oral 24 mg Bekinda ondansetron (RHB-102) met the primary endpoint of a greater proportion of patients without further vomiting, without the need for rescue medication and who were not given IV hydration from 30 minutes through 24 hours after the first dose vs. placebo (65.6% vs. 54.3%, p=0.04). In the per protocol (PP) population consisting of 299 patients who met all protocol entry criteria and for which the diagnosis of gastroenteritis was confirmed, a significantly greater proportion of patients who received Bekinda also achieved the endpoint vs. placebo (69.5% vs. 54.9%, p=0.01). Bekinda was well tolerated.

The double-blind, U.S. trial's secondary endpoints include frequency of vomiting, severity and time to resolution of nausea and time to resumption of normal activities...

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Serotonin (5-HT3) receptor