RedHill Biopharma Completes Treatment of Last Patient in BEKINDA® Phase III Study for Acute Gastroenteritis
GlobeNewswire•February 21, 2017
Top-line results are expected in the second quarter of 2017
The randomized, double-blind, placebo-controlled Phase III study is evaluating the safety and efficacy of BEKINDA® 24 mg in patients with acute gastroenteritis and gastritis (the GUARD study)
Acute gastroenteritis and gastritis are inflammations of the mucus membranes of the gastrointestinal tract which may lead to nausea, vomiting, diarrhea or abdominal pain; acute gastroenteritis is a common infectious disease, with approximately 179 million cases annually in the U.S.
If approved, BEKINDA® 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
Additionally, a Phase II study with BEKINDA® 12 mg is ongoing in the U.S. for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D), with top-line results expected in mid-2017
RedHill will host an R&D Day for analysts and investors on Thursday, April 27, 2017 in NYC with live webcast on BEKINDA®, discussing the product, indications, potential markets and the ongoing Phase III and II studies for acute gastroenteritis and IBS-D, respectively
TEL-AVIV, Israel, Feb. 21, 2017 (GLOBE NEWSWIRE) -- RedHill Biopharma Ltd. (RDHL) (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 that the last patient enrolled in the Phase III study with BEKINDA® 24 mg for the treatment of acute gastroenteritis and gastritis (the GUARD study) has completed the treatment course and observation period for the primary endpoint evaluation.
The randomized, double-blind, placebo-controlled Phase III GUARD study with BEKINDA® 24 mg is being conducted in 29 U.S. clinical sites and has treated 320 adults and children over the age of 12 with 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 GUARD study.
BEKINDA® is a proprietary, bimodal extended-release, once-daily oral pill formulation of the antiemetic drug ondansetron, targeting multiple gastrointestinal indications. BEKINDA® is intended to provide patients with relief from nausea and vomiting symptoms for a full 24-hour period with a single oral tablet.
Following the completion of patient treatment in the Phase III study with BEKINDA® for acute gastroenteritis and gastritis and in light of the advanced stage of enrollment in the Phase II study with BEKINDA® for IBS-D, RedHill will host an R&D Day with a live webcast for analysts and investors. The event will take place on Thursday, April 27, 2017 in NYC, and will discuss BEKINDA®, its indications, potential markets and the ongoing Phase III and II studies for acute gastroenteritis and IBS-D, respectively. Additional details will be provided in the coming weeks.
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 receiving the first dose of the GUARD 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 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.1 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 settings2. Gastroenteritis and gastritis are major causes of emergency room visits, with up to 474,000 estimated hospitalizations annually in the U.S. alone3. Dehydration is the most frequent and dangerous complication of acute gastroenteritis4. Oral rehydration is the preferred therapy in mild to moderate dehydration, whereas intravenous fluids are recommended in more severe cases5. Adding ondansetron, the active ingredient in BEKINDA®, to the standard intravenous rehydration therapy has shown to significantly reduce the amount of vomiting in children with gastroenteritis6, however, to the best of RedHill’s knowledge, its efficacy in adults has not been studied in a randomized clinical trial.
Ondansetron is used as an antiemetic in patients suffering from chemotherapy and radiotherapy-induced nausea and vomiting and from postoperative nausea and vomiting7. BEKINDA® 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 may reduce health care costs. If approved for marketing by the FDA, BEKINDA® 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 annually8.
