Date: 2016-06-20
Type of information: Treatment of the first patient
phase: 2
Announcement: treatment of the first patient
Company: Redhill Biopharma (Israel)
Product: Bekinda™(extended-release formulation of ondansetron)
Action
mechanism: antiemetic/5-HT3 antagonist. Bekinda™ is a proprietary, extended-release, once-daily oral pill formulation of the antiemetic drug ondansetron, targeting multiple gastrointestinal indications.
Disease: irritable bowel syndrome
Therapeutic area: Digestive diseases - Gastrointestinal diseases - Inflammatory diseases
Country: USA
Trial details:
Latest
news: * On June 20, 2016, RedHill Biopharm announced that the first patients in the Phase II clinical study with Bekinda™ (extended-release formulation of ondansetron) 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. * On April 12, 2016, RedHill Biopharma announced that it has initiated a randomized, double-blind, 2-arm parallel group Phase II clinical study in the U.S. evaluating the safety and efficacy of Bekinda™ 12 mg in patients with diarrhea-predominant irritable bowel syndrome (IBS-D). RedHill is pursuing clinical studies with two dose strengths of Bekinda™, a 24 mg dose and a 12 mg dose. 5-HT3 antagonists such as ondansetron, the active pharmaceutical ingredient in Bekinda™, have been shown to slow intestinal transit time in humans. The randomized, double-blind, 2-arm parallel group Phase II clinical study is designed to evaluate the safety and efficacy of Bekinda™ 12 mg in patients suffering from IBS-D. The study is expected to be conducted in 12 clinical sites in the U.S. and to enroll 120 patients who 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. * On February 11, 2016, RedHill Biopharma announced the successful completion of a first-in-man pharmacokinetic (PK) study of Bekinda™ 12 mg formulation, intended to be administered in the Phase II study for the treatment of diarrhea-predominant irritable bowel syndrome (IBS-D). RedHill further announced the submission to the FDA of the Investigational New Drug (IND) protocol for the Phase II clinical study with Bekinda™12 mg for IBS-D, planned to be initiated in the coming weeks, subject to finalpreparations.
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 humans.
The PK study compared the PK profile of Bekinda™ 12 mg formulation with that of the previously studied Bekinda™ 24 mg to determine the relative bioavailability and dose-linearity between the two. The PK study confirmed the results of earlier RedHill studies demonstrating equivalent dose-adjusted bioavailability and dose-linearity between the two strengths.
