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 24, 2017 (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.

Subjects enrolled in the Phase II IBS-D study were randomized 60:40 to receive either BEKINDA® 12 mg or a placebo, once daily, for a period of eight weeks. The primary endpoint for the study is the proportion of patients in each treatment group with response in stool consistency as compared to baseline, per FDA guidance definition. Secondary endpoints include the proportion of patients in each treatment group who are pain responders and the proportion of patients in each treatment group who are responders to the combined endpoints of stool consistency and pain, per FDA guidance definition.