RedHill Biopharma Initiates Phase II Study of BEKINDA(TM) for Irritable Bowel Syndrome

• The randomized, double-blind, 2-arm parallel group Phase II study of BEKINDA(TM) 12 mg is expected to enroll 120 patients suffering from diarrhea-predominant irritable bowel syndrome (IBS-D) in 12 clinical sites in the U.S. 
  
  
• The U.S. potential market for IBS-D treatments is estimated to exceed $1.3 billion by 2020
   
• A Phase III study with BEKINDA(TM) 24 mg for acute gastroenteritis and gastritis is ongoing in the U.S., with top-line results expected in the second half of 2016    

TEL-AVIV, Israel, April 11, 2016 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (TASE:RDHL) ("RedHill" or the "Company"), a biopharmaceutical company primarily focused on development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases, including cancer, today announced that it has initiated a randomized, double-blind, 2-arm parallel group Phase II clinical study in the U.S. evaluating the safety and efficacy of BEKINDA(TM) 12 mg in patients with diarrhea-predominant irritable bowel syndrome (IBS-D).

"We are excited to initiate this study of BEKINDA(TM) for IBS-D, a debilitating disorder affecting millions of people worldwide with few approved therapies and a significant unmet medical need," said Gilead Raday, RedHill's Chief Operating Officer. "This study follows publications demonstrating that ondansetron, the active ingredient in BEKINDA(TM), may be an effective and safe treatment for IBS-D. We also continue to advance the Phase III GUARD study of BEKINDA(TM) for acute gastroenteritis and gastritis, currently ongoing in the U.S., with top-line results expected during the second half of this year."

BEKINDA(TM) is a proprietary, extended-release, once-daily oral pill formulation of the antiemetic drug ondansetron, targeting multiple gastrointestinal indications. RedHill is pursuing clinical studies with two dose strengths of BEKINDA(TM), a 24 mg dose and a 12 mg dose. 5-HT3 antagonists such as ondansetron, the active pharmaceutical ingredient in BEKINDA(TM), have been shown to slow intestinal transit time in humans1. Alosetron (Lotronex®), a 5-HT3 antagonist of the same class of drugs as ondansetron, the active ingredient in BEKINDA(TM), has been approved for the treatment of women with severe chronic IBS-D but is under a restricted prescribing (REMS) program due to potential severe side effects2. Ondansetron, approved by the U.S. FDA as an oncology support antiemetic, has demonstrated activity in IBS-D in preliminary studies3 and, in light of its good safety profile, RedHill believes that BEKINDA(TM), if approved, has the potential to be a preferred once-daily treatment for a broad segment of patients suffering from IBS-D.