RedHill Biopharma Announces Enrollment of Last Patient in the BEKINDA® Phase II Study for IBS-D

• Top-line results are expected in the third quarter of 2017 
   
• The randomized, double-blind, placebo-controlled Phase II study is evaluating the safety and efficacy of BEKINDA^® (RHB-102) 12 mg in 127 U.S. patients with diarrhea-predominant irritable bowel syndrome (IBS-D)
   
• IBS is one of the most common gastrointestinal disorders; it is estimated that at least 30 million Americans suffer from IBS, of which over 40% are cases of IBS-D
   
• If approved, BEKINDA^® 12 mg has the potential to be a preferred once-daily treatment for a broad segment of patients suffering from IBS-D, targeting a U.S. potential market estimated to exceed $1 billion by 2022
   
• Top-line results from a Phase III study with BEKINDA^® 24 mg for acute gastroenteritis and gastritis (the GUARD study) are expected in the second quarter of 2017
   
• RedHill will host an R&D Day and live webcast on BEKINDA^® on Thursday, April 27, 2017 in NYC, discussing the product, indications, potential markets and the ongoing Phase III and II studies for acute gastroenteritis and IBS-D, respectively

TEL-AVIV, Israel, April 25 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) (“RedHill” or the “Company”), a specialty 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 announced enrollment of the last patient in the Phase II study with BEKINDA^® (RHB-102)¹ 12 mg for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D).

BEKINDA^® is a proprietary, bimodal extended-release, once-daily oral pill formulation of ondansetron, targeting several gastrointestinal indications.

The randomized, double-blind, placebo-controlled Phase II study is evaluating the safety and efficacy of BEKINDA^® 12 mg in adults over the age of 18 with IBS-D. The study enrolled 127 subjects in 16 U.S. clinical sites. Top-line results are expected in the third quarter of 2017.

SOURCE : RedHill Biopharma Ltd.