• Top-line results from both the ongoing Phase III clinical study for acute gastroenteritis and gastritis and the ongoing Phase II clinical study for diarrhea-predominant irritable bowel syndrome (IBS-D) are expected in mid-2017
• Over two-thirds of the planned total of 320 subjects have been enrolled to date in the Phase III clinical study with BEKINDA® 24 mg for acute gastroenteritis and gastritis in the U.S. (the GUARD study)
• Approximately half of the planned total of 120 subjects have been enrolled to date in the Phase II clinical study with BEKINDA® 12 mg for the treatment of IBS-D in the U.S.
• Worldwide potential market for gastroenteritis and gastritis treatments are estimated to exceed $650 million annually
• U.S. potential market for IBS-D treatments is estimated to exceed $1.3 billion by 2020
Tel-Aviv, Israel, November 03, 2016 / B3C newswire / -- RedHill Biopharma Ltd. (NASDAQ: RDHL) (TASE: RDHL) (“RedHill” or the “Company”), a 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 provided an update on its ongoing Phase III and Phase II clinical studies with BEKINDA® for the treatment of acute gastroenteritis and gastritis and for diarrhea-predominant irritable bowel syndrome (IBS-D), respectively. BEKINDA® is a proprietary, extended-release, once-daily oral pill formulation of the antiemetic drug ondansetron, targeting multiple gastrointestinal indications. A Phase III study with BEKINDA® 24 mg for acute gastroenteritis and gastritis is ongoing in the U.S. (the GUARD study). A Phase II study with BEKINDA® 12 mg is also ongoing in the U.S. for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). Top-line results from both studies are expected in mid-2017.
Acute gastroenteritis and gastritis - Phase III study
The ongoing randomized, double-blind, placebo-controlled GUARD Phase III study with BEKINDA® 24 mg for acute gastroenteritis and gastritis is being conducted at up to 30 sites in the U.S. and is enrolling adults and children over the age of 12 who suffer from acute gastroenteritis and gastritis. 226 subjects, over two-thirds of the planned total of 320 subjects, have been enrolled in the study to date, and top-line results are expected in mid-2017.
The primary endpoint for the study is the absence of vomiting and the absence of the need for rescue medications or intravenous hydration after 30 minutes and through 24 hours after the first dose of the study medication. 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 FDA RedHill believes that, subject to achieving highly significant positive results, the Phase III GUARD study may be sufficient as a single study to support potential future marketing applications in the U.S., conditional upon, among other things, future review and guidance from the FDA. BEKINDA® is intended to provide patients with relief from nausea and vomiting symptoms for a full 24-hour period with a single oral tablet and, if approved, may also reduce the burden on health systems by reducing hospital readmissions. According to one estimate, there are over 179 million cases of gastroenteritis and gastritis annually in the U.S. alone(1). The worldwide potential market for gastroenteritis and gastritis treatments is estimated to exceed $650 million annually(2).
IBS-D - Phase II study
The ongoing randomized, double-blind, placebo-controlled Phase II clinical study is intended to evaluate the safety and efficacy of BEKINDA® 12 mg in adults over the age of 18 who suffer from IBS-D, at up to 16 clinical sites in the U.S. Approximately half of the total 120 planned subjects have been enrolled in the study to date, and top-line results are expected in mid-2017.
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.
IBS is one of the most common gastrointestinal disorders. It is estimated that at least 30 million Americans suffer from IBS(3), of which over 50% are cases of IBS-D4. The U.S. potential market for IBS-D treatments is estimated to exceed $1.3 billion by 2020(4). 5-HT3 antagonists such as ondansetron, the active pharmaceutical ingredient in BEKINDA®, have been shown to slow intestinal transit time in humans(5). Alosetron (Lotronex®), a 5-HT3 antagonist of the same class of drugs as ondansetron, has been approved for the treatment of women with severe chronic IBS-D but is under a restricted prescribing (REMS) program due to potential severe side effects(6). Ondansetron, approved by the FDA as an oncology support antiemetic, has demonstrated activity in IBS-D in preliminary studies(7) and, in light of its good safety profile, RedHill believes that BEKINDA®, if approved, has the potential to be a preferred once-daily treatment for a broad segment of patients suffering from IBS-D.
About BEKINDA® (RHB-102)
BEKINDA® is a proprietary, bimodal extended-release (24 hours) oral pill formulation of ondansetron covered by several issued and pending patents. A Phase III clinical study of BEKINDA® 24 mg formulation for acute gastroenteritis and gastritis (the GUARD study) is ongoing in the U.S., with top-line results expected in mid-2017. A Phase II study with BEKINDA® 12 mg formulation 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 is also pursuing a potential marketing approval of BEKINDA® in Europe for the prevention of chemotherapy and radiotherapy-induced nausea and vomiting (CINV and RINV, respectively), pending additional feedback from EU member states as to whether additional clinical and CMC work is required.
About RedHill Biopharma Ltd.
RedHill Biopharma Ltd. (NASDAQ/TASE: RDHL) is a biopharmaceutical company headquartered in Israel, primarily focused on the development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for the treatment of gastrointestinal and inflammatory diseases and cancer. RedHill’s current pipeline of proprietary products includes: (i) RHB-105- an oral combination therapy for the treatment of Helicobacter pylori infection with successful results from a first Phase III study; (ii) RHB-104- an oral combination therapy for the treatment of Crohn’s disease with an ongoing first Phase III study and an ongoing proof-of-concept Phase IIa study for multiple sclerosis; (iii) BEKINDA® (RHB-102)- a once-daily oral pill formulation of ondansetron with an ongoing Phase III study for acute gastroenteritis and gastritis and an ongoing Phase II study for IBS-D; (iv) RHB-106- an encapsulated bowel preparation licensed to Salix Pharmaceuticals, Ltd.; (v) YELIVA™ (ABC294640)- a Phase II-stage, orally-administered, first-in-class SK2 selective inhibitor targeting multiple oncology, inflammatory and gastrointestinal indications; (vi) MESUPRON - a Phase II-stage first-in-class, orally-administered uPA inhibitor, targeting gastrointestinal and other solid tumors; (vii) RP101- currently subject to an option-to-acquire by RedHill, RP101 is a Phase II-stage first-in-class, orally-administered Hsp27 inhibitor, targeting pancreatic and other gastrointestinal cancers; (viii) RIZAPORT® (RHB-103)- an oral thin film formulation of rizatriptan for acute migraines, with a U.S. NDA currently under discussion with the FDA and marketing authorization received in Germany in October 2015; and (ix) RHB-101- a once-daily oral pill formulation of the cardio drug carvedilol.
