The last patient in the Phase II BEKINDA (RBH-102) study has completed the treatment and follow-up, RedHill Biopharma Ltd. announced on Monday.
RedHill expects top-line results from the study in September.
The extended-release, once daily BEKINDA (ondansetron) pill was being evaluated for efficacy and safety for patients suffering from diarrhea-predominant irritable bowel syndrome (IBS-D). One hundred and twenty-seven adults participated in the study at 16 U.S. sites.
The participants were divided into two groups with a 60/40 ratio of patients receiving BEKINDA 12 mg or a placebo, respectively. The active ingredient in BEKINDA, ondansetron, slows intestinal transit time. It has shown potential in preliminary IBS-D studies.
The primary endpoint is the stool consistency response and pain. Researchers are looking for a decrease in the days per week with one or more stools with a 6 or 7 on the Bristol stool scale and no increase in abdominal pain.
A different medication from the same class of drugs has been approved for treatment of IBS-D under a restricted prescribing program due to potential side effects by the Food and Drug Administration. Ondansetraon has a better safety profile and potential to become the preferred treatment for IBS-D patients.
BEKINDA 24 mg was the subject of a Phase III clinical trial focused on acute gastroenteritis and gastritis. Positive top-line results were released in June.