RedHill Biopharma Announces Successful Phase III Top-Line Results with BEKINDA® for Acute Gastroenteritis

·         The positive Phase III top-line results indicate that the study successfully met its primary endpoint and BEKINDA^® 24 mg was shown to be effective, safe and well tolerated in patients with acute gastroenteritis and gastritis

·         RedHill will host a conference call and webcast to discuss the top-line results from the BEKINDA^® Phase III study on Wednesday, June 21, 2017, at 8:00 am EDT; Please visit the Company’s website for dial-in information and webcast access: http://ir.redhillbio.com/events.cfm

TEL-AVIV, Israel and RALEIGH, N.C., June 15 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) (“RedHill” or the “Company”), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary, orally-administered, small molecule drugs for gastrointestinal and inflammatory diseases and cancer, today announced positive top-line results from the Phase III GUARD study with BEKINDA^® (RHB-102)¹ 24 mg for acute gastroenteritis and gastritis. The study successfully met its primary endpoint of efficacy in treatment of acute gastroenteritis. BEKINDA^® was found to be safe and well tolerated in this indication.

The randomized, double-blind, placebo-controlled Phase III GUARD study evaluated the efficacy and safety of BEKINDA^® 24 mg in treating acute gastroenteritis and gastritis. 321 adults and children over the age of 12 were enrolled at 21 clinical sites in the U.S. and randomized in a 60:40 ratio to receive either BEKINDA^® 24 mg or placebo, respectively. The primary endpoint of the study was the proportion of patients without further vomiting, without rescue medication, and who were not given intravenous hydration from 30 minutes post first dose of the study drug until 24 hours post dose, compared to placebo.

Top-line results indicated that the Phase III GUARD study successfully met its primary endpoint in the Intent to Treat (ITT) population (p = 0.04), despite high positive outcome rate in the placebo arm. BEKINDA^® improved the efficacy outcome by 21%; 65.6% of BEKINDA^® treated patients as compared to 54.3% of placebo patients (p = 0.04; n=192 in the BEKINDA^® group and n=129 in the placebo group).  Correcting for a randomization error, the difference in effect is greater with 65.8% vs. 53.9% favoring BEKINDA^® vs. placebo in reaching the primary endpoint of the study (p = 0.03). In per-protocol (PP) analysis of patients who met all protocol entry criteria and for which the diagnosis of gastroenteritis was confirmed (n=177 in the BEKINDA^® group and n=122 in the placebo group), BEKINDA^® improved the efficacy outcome by 27%; 69.5% of patients in the BEKINDA^® group vs. 54.9% in the placebo group (p = 0.01). BEKINDA^® 24 mg was also shown to be safe and well-tolerated. Importantly, electrocardiogram results showed no adverse changes with treatment.

Robert A. Silverman, MD, MS, Emergency Medicine specialist at Northwell Health and Lead Investigator of the BEKINDA^® Phase III GUARD study, said: "The positive results of the Phase III GUARD study demonstrate that BEKINDA^® 24 mg is beneficial in the treatment of acute gastroenteritis and gastritis and can provide patients with 24 hours of relief. Gastroenteritis is a very common illness in the U.S., with approximately 179 million cases annually. If approved by FDA, BEKINDA^® may become the new standard of care helping us treat patients quickly and effectively in both the emergency and outpatient settings.”

Terry F. Plasse, MD, RedHill’s Medical Director, added: “We are excited about the positive outcome of the Phase III GUARD study, which met its efficacy primary endpoint and demonstrated the safety and tolerability of BEKINDA^® 24 mg. Notably, when looking at results by initial severity of nausea, we see a treatment effect even in patients with very severe nausea at baseline, suggesting that the drug works regardless of the initial severity of gastroenteritis. We continue to analyze the data, with the final clinical study report expected in the third quarter of 2017. We look forward to presenting the data to the FDA and discussing the potential path for marketing approval of BEKINDA^® 24 mg in the U.S. and whether additional clinical studies are required prior to NDA filing. We are also expecting top-line Phase II results from the clinical study of BEKINDA^® 12 mg in diarrhea-predominant irritable bowel syndrome (IBS-D) in September 2017. I would like to thank the patients, investigators, clinical staff and service providers who participated in the GUARD study and commend the RedHill team for achieving this important milestone.”