RedHill Biopharma Ltd (RDHL)

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http://ir.redhillbio.com/releasedetail.cfm?ReleaseID=997343

RedHill Biopharma Provides Update on Ongoing Phase III and Phase II studies with BEKINDA® and Expected Timing of Top-Line Results



Top-line results from both the ongoing Phase III clinical study for acute gastroenteritis and gastritis and the ongoing Phase II clinical study for diarrhea-predominant irritable bowel syndrome (IBS-D) are expected in mid-2017

Over two-thirds of the planned total of 320 subjects have been enrolled to date in the Phase III clinical study with BEKINDA® 24 mg for acute gastroenteritis and gastritis in the U.S. (the GUARD study)


Approximately half of the planned total of 120 subjects have been enrolled to date in the Phase II clinical study with BEKINDA® 12 mg for the treatment of IBS-D in the U.S.

Worldwide potential market for gastroenteritis and gastritis treatments are estimated to exceed $650 million annually

U.S. potential market for IBS-D treatments is estimated to exceed $1.3 billion by 2020
TEL-AVIV, Israel, Nov. 03, 2016 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) (“RedHill” or the “Company”), a biopharmaceutical company primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today provided an update on its ongoing Phase III and Phase II clinical studies with BEKINDA® for the treatment of acute gastroenteritis and gastritis and for diarrhea-predominant irritable bowel syndrome (IBS-D), respectively.

BEKINDA® is a proprietary, extended-release, once-daily oral pill formulation of the antiemetic drug ondansetron, targeting multiple gastrointestinal indications. A Phase III study with BEKINDA® 24 mg for acute gastroenteritis and gastritis is ongoing in the U.S. (the GUARD study). A Phase II study with BEKINDA® 12 mg is also ongoing in the U.S. for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). Top-line results from both studies are expected in mid-2017.