RedHill Biopharma Ltd, 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 III study with BEKINDAŽ 24 mg for the treatment of acute gastroenteritis and gastritis (the GUARD study).
The randomized, double-blind, placebo-controlled Phase III GUARD study with BEKINDAŽ 24 mg is conducted in 29 U.S. clinical sites and treated 320 adults and children over the age of 12 who suffered from acute gastroenteritis and gastritis. Top-line results are expected in the second quarter of 2017.
Robert A. Silverman, MD, MS, Emergency Medicine specialist at the Hofstra North Shore-LIJ Medical Center, and Associate Professor at the Hofstra North Shore-LIJ School of Medicine in New York, is the lead investigator for the study.
BEKINDAŽ is a proprietary, bimodal extended-release, once-daily oral pill formulation of the antiemetic drug ondansetron, targeting multiple gastrointestinal indications. BEKINDAŽ is intended to provide patients with relief from nausea and vomiting symptoms for a full 24-hour period with a single oral tablet.
The primary endpoint for the GUARD study is the absence of vomiting or the need for rescue medications or intravenous hydration from 30 minutes through 24 hours after the first dose of the study drug. Secondary endpoints include, among others, frequency of vomiting, severity and time to resolution of nausea and time to resumption of normal activities.
As previously announced, in light of discussions with the U.S. Food and Drug Administration (FDA), RedHill believes that, subject to achieving highly significant positive results, the Phase III GUARD study may be sufficient as a single Phase III study to support potential future marketing application in the U.S., conditional upon, among other things, future review and guidance from the FDA.
Acute gastroenteritis and gastritis are inflammations of the mucus membranes of the gastrointestinal tract leading to a combination of symptoms which include nausea, vomiting, diarrhea or abdominal pain. Acute gastroenteritis is a common infectious disease, with approximately 179 million cases annually in the U.S.. It is caused by many different infectious agents, most commonly by viral infections, accounting for up to 70% of cases. Noroviruses cause the most outbreaks of non-bacterial acute gastroenteritis in all age groups and often occur in epidemic outbreaks in schools, nursing homes and other group settings.
Gastroenteritis and gastritis are major causes of emergency room visits, with up to 474,000 estimated hospitalizations annually in the U.S. alone. Dehydration is the most frequent and dangerous complication of acute gastroenteritis. Oral rehydration is the preferred therapy in mild to moderate dehydration, whereas intravenous fluids are recommended in more severe cases(4). Adding ondansetron, the active ingredient in BEKINDAŽ, to the standard intravenous rehydration therapy has shown to significantly reduce the amount of vomiting in children with gastroenteritis, however, to the best of RedHills knowledge, its efficacy in adults has not been studied in a randomized clinical trial in the U.S.
Ondansetron is used as an antiemetic in patients suffering from chemotherapy and radiotherapy-induced nausea and vomiting and from postoperative nausea and vomiting. BEKINDAŽ may decrease the frequency of vomiting, improve the success and compliance of oral rehydration therapy and decrease the rate of intravenous therapy in patients suffering from gastroenteritis. It may also decrease the number of emergency room visits, and therefore reduce health care costs. If approved for marketing by the FDA, BEKINDAŽ could become the first 5-HT3 antiemetic drug in the U.S. indicated for the treatment of acute gastroenteritis and gastritis, targeting a potential worldwide market estimated to exceed $650 million annually.
BEKINDAŽ is being studied for additional indications. A randomized, double-blind, placebo-controlled Phase II study with BEKINDAŽ 12 mg is currently ongoing in the U.S. for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). The Phase II study is evaluating the safety and efficacy of BEKINDAŽ 12 mg in adults over the age of 18 who suffer from IBS-D at 16 clinical sites in the U.S. 96 of the planned total of 120 subjects have been enrolled to date. Top-line results are expected in mid-2017.
The Phase III GUARD study and the Phase II study with BEKINDAŽ are registered on www.ClinicalTrials.gov, a web-based service of the U.S. National Institutes of Health, which provides access to information on publicly and privately supported clinical studies.