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IBS is one of the most common gastrointestinal disorders, estimated to affect at least 30 million Americans of which over 50% suffer from IBS-D
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A Phase III study with BEKINDA™ 24 mg for acute gastroenteritis and gastritis is ongoing in the U.S., with top-line results expected in late 2016
TEL-AVIV, Israel I June 20, 2016 I RedHill Biopharma Ltd. (RDHL) (RDHL) (“RedHill” or the “Company”), a biopharmaceutical company primarily focused on development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases and cancer, today announced that the first patients in the Phase II clinical study with BEKINDA™ 12 mg for diarrhea-predominant irritable bowel syndrome (IBS-D) have been dosed.
The randomized, double-blind, placebo-controlled Phase II clinical study is expected to enroll 120 subjects in 12 clinical sites in the U.S. and is intended to evaluate the safety and efficacy of BEKINDA™ 12 mg in patients with IBS-D.
BEKINDA™ is a proprietary, extended-release, once-daily oral pill formulation of the antiemetic drug ondansetron, targeting multiple gastrointestinal indications. RedHill is pursuing clinical studies with two dose strengths of BEKINDA™, a 24 mg dose and a 12 mg dose, for two different indications. A Phase III study of BEKINDA™ 24 mg for acute gastroenteritis and gastritis is ongoing in the U.S. (the GUARD study), with top-line results expected in late 2016.
Subjects enrolled in the Phase II study will be randomized 60:40 to receive either BEKINDA™ 12 mg or a placebo, once daily, for a period of eight weeks. 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.
5-HT3 antagonists such as ondansetron, the active pharmaceutical ingredient in BEKINDA™, have been shown to slow intestinal transit time in humans1. 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 effects2. Ondansetron, approved by the U.S. FDA as an oncology support antiemetic, has demonstrated activity in IBS-D in preliminary studies3 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.
IBS is a chronic multifactorial disorder characterized by recurrent abdominal pain or discomfort associated with altered bowel function. Diarrhea-predominant irritable bowel syndrome is the most common subtype of IBS in the U.S.4 Certain factors that may alter gastrointestinal function can contribute to IBS symptoms, including stress, prior gastroenteritis and changes in the gut microbiome. However, the etiology of IBS is not understood and the underlying cause of IBS remains unknown. IBS negatively impacts patients’ quality of life and can affect patients physically, emotionally, socially and economically.
IBS is one of the most common GI disorders; it is estimated that at least 30 million Americans suffer from IBS5, 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 20206.
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 late 2016. 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). RedHill is also pursuing 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. (RDHL) (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 inflammatory and gastrointestinal 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 in the U.S. 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 uPA inhibitor, administered by oral capsule, 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 Hsp27 inhibitor, administered by oral tablet, 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.
SOURCE: RedHill Biopharma
Post Views: 162
-
IBS is one of the most common gastrointestinal disorders, estimated to affect at least 30 million Americans of which over 50% suffer from IBS-D
-
A Phase III study with BEKINDA™ 24 mg for acute gastroenteritis and gastritis is ongoing in the U.S., with top-line results expected in late 2016
TEL-AVIV, Israel I June 20, 2016 I RedHill Biopharma Ltd. (RDHL) (RDHL) (“RedHill” or the “Company”), a biopharmaceutical company primarily focused on development and commercialization of late clinical-stage, proprietary, orally-administered, small molecule drugs for inflammatory and gastrointestinal diseases and cancer, today announced that the first patients in the Phase II clinical study with BEKINDA™ 12 mg for diarrhea-predominant irritable bowel syndrome (IBS-D) have been dosed.
The randomized, double-blind, placebo-controlled Phase II clinical study is expected to enroll 120 subjects in 12 clinical sites in the U.S. and is intended to evaluate the safety and efficacy of BEKINDA™ 12 mg in patients with IBS-D.
BEKINDA™ is a proprietary, extended-release, once-daily oral pill formulation of the antiemetic drug ondansetron, targeting multiple gastrointestinal indications. RedHill is pursuing clinical studies with two dose strengths of BEKINDA™, a 24 mg dose and a 12 mg dose, for two different indications. A Phase III study of BEKINDA™ 24 mg for acute gastroenteritis and gastritis is ongoing in the U.S. (the GUARD study), with top-line results expected in late 2016.
Subjects enrolled in the Phase II study will be randomized 60:40 to receive either BEKINDA™ 12 mg or a placebo, once daily, for a period of eight weeks. 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.
5-HT3 antagonists such as ondansetron, the active pharmaceutical ingredient in BEKINDA™, have been shown to slow intestinal transit time in humans1. 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 effects2. Ondansetron, approved by the U.S. FDA as an oncology support antiemetic, has demonstrated activity in IBS-D in preliminary studies3 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.
IBS is a chronic multifactorial disorder characterized by recurrent abdominal pain or discomfort associated with altered bowel function. Diarrhea-predominant irritable bowel syndrome is the most common subtype of IBS in the U.S.4 Certain factors that may alter gastrointestinal function can contribute to IBS symptoms, including stress, prior gastroenteritis and changes in the gut microbiome. However, the etiology of IBS is not understood and the underlying cause of IBS remains unknown. IBS negatively impacts patients’ quality of life and can affect patients physically, emotionally, socially and economically.
IBS is one of the most common GI disorders; it is estimated that at least 30 million Americans suffer from IBS5, 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 20206.
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 late 2016. 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). RedHill is also pursuing 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. (RDHL) (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 inflammatory and gastrointestinal 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 in the U.S. 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 uPA inhibitor, administered by oral capsule, 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 Hsp27 inhibitor, administered by oral tablet, 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.
SOURCE: RedHill Biopharma
Post Views: 162
