Successful Phase III top-line results with Bekinda for acute gastroenteritis

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.

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, 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. 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. In per-protocol (PP) analysis of patients who met all protocol entry criteria and for which the diagnosis of gastroenteritis was confirmed, Bekinda improved the efficacy outcome by 27%; 69.5% of patients in the Bekinda group vs. 54.9% in the placebo group. Bekinda 24 mg was also shown to be safe and well-tolerated. Importantly, electrocardiogram results showed no adverse changes with treatment.

Robert A. Silverman, 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 US, 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, 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 analyse 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 US 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.”

Bekinda is a proprietary, bimodal extended-release, once-daily oral pill formulation of the antiemetic drug ondansetron, targeting several gastrointestinal indications. Bekinda 24 mg is intended to provide patients with relief from nausea and vomiting symptoms for a full 24-hour period with a single oral tablet. If approved for marketing by the FDA, Bekinda 24 mg could become the first 5-HT3 antiemetic drug in the US indicated for the treatment of acute gastroenteritis and gastritis.

RedHill will continue to analyse the GUARD Phase III study top-line data, including secondary endpoints, and plans to meet with the FDA to present the data and discuss the clinical and regulatory path towards potential marketing approval of Bekinda 24 mg in the US. Additional clinical studies may be required prior to potential submission of a New Drug Application (NDA).

The top-line results from the GUARD Phase III study were provided to RedHill by an independent third party following an independent analysis and remain subject to completion of the independent review and analysis of the underlying data, including all safety, secondary and other outcome measures, and completion of the Clinical Study Report (CSR), expected in the third quarter of 2017.