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.

Acute gastroenteritis and gastritis - Phase III study

The ongoing randomized, double-blind, placebo-controlled GUARD Phase III study with BEKINDA ® 24 mg for acute gastroenteritis and gastritis is being conducted at up to 30 sites in the U.S. and is enrolling adults and children over the age of 12 who suffer from acute gastroenteritis and gastritis. 226 subjects, over two-thirds of the planned total of 320 subjects, have been enrolled in the study to date, and top-line results are expected in mid-2017.

The primary endpoint for the study is the absence of vomiting and the absence of the need for rescue medications or intravenous hydration after 30 minutes and through 24 hours after the first dose of the study medication. Secondary endpoints include, among others, frequency of vomiting, severity and time to resolution of nausea and time to resumption of normal activities.

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